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A Study to Evaluate the Safety and Tolerability of ABBV-951 in Subjects With Parkinson's Disease (PD)

Primary Purpose

Parkinson's Disease (PD)

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
ABBV-951
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease (PD) focused on measuring Parkinson's Disease (PD), ABBV-951, Levodopa/Carbidopa

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participants with diagnosis of idiopathic Parkinson's Disease (PD) that is levodopa -responsive
  • Participants must be judged by the investigator to be inadequately controlled by current therapy, have recognizable/identifiable "Off" and "On" states (motor fluctuations), and have a minimum of 2.5 hours of "Off" time per day

Exclusion Criteria:

  • Participant is cognitively impaired and is not able to safely and effectively manage the drug delivery system and the diaries and is not able to adhere to the study.
  • Participant is considered by the investigator to be an unsuitable candidate to receive ABBV-951 for any reason.

Sites / Locations

  • University of Alabama at Birmingham - Main /ID# 207996
  • Banner Sun Health Res Inst /ID# 208811
  • The Parkinson's & Movement Disorder Institute - Fountain Valley /ID# 216126
  • University of Colorado Hospital /ID# 207968
  • Parkinson's Disease and Movement Disorders Center of Boca Raton /ID# 207677
  • Northwestern University Feinberg School of Medicine /ID# 208812
  • Indiana Clinical Research Cent /ID# 207952
  • Univ Kansas Med Ctr /ID# 208963
  • University of Kentucky Chandler Medical Center /ID# 207603
  • Massachusetts General Hospital /ID# 207993
  • Health Partners /ID# 207950
  • University of Missouri /ID# 209043
  • Washington University-School of Medicine /ID# 207525
  • Dartmouth-Hitchcock Medical Center /ID# 207972
  • Wake Radiology UNC REX Healthcare - Raleigh Office /ID# 209784
  • Legacy Medical Group - Neurology /ID# 208031
  • Prisma Health Cancer Institute-Faris Road /ID# 207650
  • Neurology Consultants of Dallas - LBJ Fwy /ID# 207619
  • Baylor College of Medicine /ID# 207620
  • Central Texas Neurology Consul /ID# 216918
  • Univ Texas HSC San Antonio /ID# 208958
  • Booth Gardner Parkinson's Care Center /ID# 208026
  • Inland Northwest Research /ID# 208122
  • Medical College of Wisconsin /ID# 207999
  • Concord Repatriation General Hospital /ID# 207628
  • Westmead Hospital /ID# 207633
  • Royal Adelaide Hospital /ID# 207634
  • Alfred Health /ID# 207632
  • Perron Institute /ID# 207627
  • Universitair Ziekenhuis Leuven /ID# 209058
  • AZ Sint-Jan Brugge /ID# 208178
  • Groupe Sante CHC - Clinique du MontLegia /ID# 208177
  • University of Calgary - Movement Disorders Clinic /ID# 207342
  • Centre de Recherche St-Louis /ID# 207344
  • Bispebjerg and Frederiksberg Hospital /ID# 207669
  • Aarhus University Hospital /ID# 207668
  • Odense University Hospital /ID# 207871
  • Universitaetsklinikum Ulm /ID# 208602
  • Kliniken Beelitz GmbH /ID# 208600
  • InnKlinikum Haag /ID# 208601
  • IRCCS Centro Neurolesi Bonino Pulejo /ID# 207975
  • Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 207955
  • Azienda Ospedaliera di Padova /ID# 208077
  • National Hospital Organization Asahikawa Medical Center /ID# 210914
  • National Hospital Organization Utano National Hospital /ID# 210912
  • Osaka University Hospital /ID# 210913
  • Juntendo University Hospital /ID# 210915
  • National Center of Neurology and Psychiatry /ID# 210911
  • Erasmus Medisch Centrum /ID# 208168
  • St. Antonius Ziekenhuis /ID# 208529
  • City Clinical Hospital #40 /ID# 216301
  • Academician I.P. Pavlov First St. Petersburg State Medical University /ID# 216303
  • Hospital General Universitario de Elche /ID# 209777
  • Hospital Universitario de Bellvitge /ID# 209539
  • Hospital Universitario A Coruna - CHUAC /ID# 212147
  • Hospital Santa Creu i Sant Pau /ID# 208240
  • Hospital Universitario Virgen de las Nieves /ID# 208242
  • Hospital Universitario Ramon y Cajal /ID# 208241
  • Hospital Universitario Virgen del Rocio /ID# 208239
  • Skane University Hospital Lund /ID# 207811
  • Centrum for neurologi /ID# 207716
  • Sahlgrenska University Hospital /ID# 207718
  • NHS Tayside /ID# 209242
  • King's College Hospital NHS Foundation Trust /ID# 208413
  • University Hospital Plymouth NHS Trust /ID# 208447

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

ABBV-951 Low Dose Subgroup

ABBV-951 High Dose Subgroup

Arm Description

After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was < 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup.

After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup.

Outcomes

Primary Outcome Measures

Number of Participants With Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.
Number of Participants With Adverse Events of Special Interest
Treatment emergent adverse events of special interest are defined as any adverse event of infusion site infections, infusion site reactions, hallucinations/psychosis, falls and associated injuries, polyneuropathy (peripheral neuropathy), weight loss, or somnolence from the first dose of study drug until 30 days following last dose of study drug.
Number of Participants With Numeric Grade Equal to or Higher Than 5 and With Letter Grade Equal to or Higher Than D on the Infusion Site Evaluation Scale
Skin tolerability was assessed using the Infusion Site Evaluation Scale, a 2-part numeric (0-7) and letter (A-G) grade scale, where a notable skin reaction is defined as a reaction with a numeric grade of 6 or 7 or a letter grade of D, E, F, or G. Any observation of infusion site reaction with irritation criteria > 2 or > C was recorded as an adverse event (AE).
Hematocrit (Hematology): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Hemoglobin (Hematology): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Red Blood Cell (RBC) Count (Hematology): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
White Blood Cell (WBC) Count (Hematology): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Neutrophils (Hematology): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Lymphocytes (Hematology): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Monocytes (Hematology): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Absolute Platelet Count (Hematology): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Mean Corpuscular Hemoglobin (Hematology): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Mean Corpuscular Volume Concentration (MCHC) (Hematology): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Prothrombin Time (PT) (Hematology): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Activated Partial Thromboplastin Time (Hematology): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Blood Urea Nitrogen (BUN) (Clinical Chemistry): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Creatinine (Clinical Chemistry): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Creatine Phosphokinase (Clinical Chemistry): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Total Bilirubin (Clinical Chemistry): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Serum Alanine Aminotransferase (Clinical Chemistry): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Serum Aspartate Aminotransferase (Clinical Chemistry): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Serum Lactate Dehydrogenase (LDH) (Clinical Chemistry): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Gamma-glutamyl Transferase (Clinical Chemistry): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Alkaline Phosphatase (Clinical Chemistry): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Sodium (Clinical Chemistry): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Potassium (Clinical Chemistry): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Calcium (Clinical Chemistry): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Inorganic Phosphorus (Clinical Chemistry): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Uric Acid (Clinical Chemistry): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Total Cholesterol (Clinical Chemistry): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Albumin (Clinical Chemistry): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Glucose (Clinical Chemistry): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Sodium Bicarbonate/CO2 (Clinical Chemistry): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Magnesium (Clinical Chemistry): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Creatinine Clearance (Clinical Chemistry): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Homocysteine (Clinical Chemistry): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Vitamin B6 (Clinical Chemistry): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Vitamin B12 (Clinical Chemistry): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
pH (Urinalysis): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Specific Gravity (Urinalysis): Change From Baseline to End of Study
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Orthostatic Systolic Blood Pressure (Vital Signs): Change From Baseline to End of Study
Orthostatic blood pressure was measured after the participant had been supine (lying down with their face up) for at least 5 minutes and then, after the participant had been standing for 2 minutes. When vital sign measurements were scheduled at the same time as a blood collection, vital sign measurements were obtained prior to blood collection.
Orthostatic Diastolic Blood Pressure (Vital Signs): Change From Baseline to End of Study
Orthostatic blood pressure was measured after the participant had been supine (lying down with their face up) for at least 5 minutes and then, after the participant had been standing for 2 minutes. When vital sign measurements were scheduled at the same time as a blood collection, vital sign measurements were obtained prior to blood collection.
Orthostatic Pulse Rate (Vital Signs): Change From Baseline to End of Study
Orthostatic pulse rate was measured after the participant had been supine (lying down with their face up) for at least 5 minutes and then, after the participant had been standing for 2 minutes. When vital sign measurements were scheduled at the same time as a blood collection, vital sign measurements were obtained prior to blood collection.
Electrocardiogram (ECG) Mean Heart Rate: Change From Baseline to End of Study
12-lead electrocardiograms (ECGs) were recorded at study visits after the participant had been supine for at least 5 minutes. Participants were instructed to remain stationary (no talking, laughing, deep breathing, sleeping, or swallowing) for approximately 10 seconds during the ECG recording. When an ECG was recorded at a time near that of a blood collection, the ECG was obtained prior to the blood collection. ECGs on Day 1 were recorded after initiation of the continuous subcutaneous infusion (CSCI) of ABBV-951 prior to the end of the study visit.
Electrocardiogram (ECG) Aggregate PR Interval: Change From Baseline to End of Study
12-lead electrocardiograms (ECGs) were recorded at study visits after the participant had been supine for at least 5 minutes. Participants were instructed to remain stationary (no talking, laughing, deep breathing, sleeping, or swallowing) for approximately 10 seconds during the ECG recording. When an ECG was recorded at a time near that of a blood collection, the ECG was obtained prior to the blood collection. ECGs on Day 1 were recorded after initiation of the continuous subcutaneous infusion (CSCI) of ABBV-951 prior to the end of the study visit.
Electrocardiogram (ECG) Aggregate QRS Duration: Change From Baseline to End of Study
12-lead electrocardiograms (ECGs) were recorded at study visits after the participant had been supine for at least 5 minutes. Participants were instructed to remain stationary (no talking, laughing, deep breathing, sleeping, or swallowing) for approximately 10 seconds during the ECG recording. When an ECG was recorded at a time near that of a blood collection, the ECG was obtained prior to the blood collection. ECGs on Day 1 were recorded after initiation of the continuous subcutaneous infusion (CSCI) of ABBV-951 prior to the end of the study visit.
Electrocardiogram (ECG) Aggregate QT Interval: Change From Baseline to End of Study
12-lead electrocardiograms (ECGs) were recorded at study visits after the participant had been supine for at least 5 minutes. Participants were instructed to remain stationary (no talking, laughing, deep breathing, sleeping, or swallowing) for approximately 10 seconds during the ECG recording. When an ECG was recorded at a time near that of a blood collection, the ECG was obtained prior to the blood collection. ECGs on Day 1 were recorded after initiation of the continuous subcutaneous infusion (CSCI) of ABBV-951 prior to the end of the study visit.
Electrocardiogram (ECG) Aggregate QTcB Interval: Change From Baseline to End of Study
12-lead electrocardiograms (ECGs) were recorded at study visits after the participant had been supine for at least 5 minutes. Participants were instructed to remain stationary (no talking, laughing, deep breathing, sleeping, or swallowing) for approximately 10 seconds during the ECG recording. When an ECG was recorded at a time near that of a blood collection, the ECG was obtained prior to the blood collection. ECGs on Day 1 were recorded after initiation of the continuous subcutaneous infusion (CSCI) of ABBV-951 prior to the end of the study visit.
Electrocardiogram (ECG) Aggregate QTcF Interval: Change From Baseline to End of Study
12-lead electrocardiograms (ECGs) were recorded at study visits after the participant had been supine for at least 5 minutes. Participants were instructed to remain stationary (no talking, laughing, deep breathing, sleeping, or swallowing) for approximately 10 seconds during the ECG recording. When an ECG was recorded at a time near that of a blood collection, the ECG was obtained prior to the blood collection. ECGs on Day 1 were recorded after initiation of the continuous subcutaneous infusion (CSCI) of ABBV-951 prior to the end of the study visit.
Electrocardiogram (ECG) Aggregate RR Interval: Change From Baseline to End of Study
12-lead electrocardiograms (ECGs) were recorded at study visits after the participant had been supine for at least 5 minutes. Participants were instructed to remain stationary (no talking, laughing, deep breathing, sleeping, or swallowing) for approximately 10 seconds during the ECG recording. When an ECG was recorded at a time near that of a blood collection, the ECG was obtained prior to the blood collection. ECGs on Day 1 were recorded after initiation of the continuous subcutaneous infusion (CSCI) of ABBV-951 prior to the end of the study visit.

Secondary Outcome Measures

Average Daily Normalized "Off" Time: Change From Baseline to End of Study
Upon awakening and every 30 minutes during their normal waking time, participants recorded their state in the Parkinson's Disease Diary (PD Diary) for 2 consecutive days prior to study visits. "Off" time is defined as periods of poor mobility, tremor, slowness, and stiffness. The daily "On" and "Off" times were normalized to a typical waking day (16 hours) to account for different sleep patterns across participants. When "Off" was the first morning symptom upon awakening, this was considered morning akinesia in this study. Baseline value is defined as the average of normalized "Off" time collected over the 2 PD Diary days before the Enrollment visit. Negative changes from Baseline indicate improvement.
Average Daily Normalized "On" Time With Troublesome Dyskinesia: Change From Baseline to End of Study
Upon awakening and every 30 minutes during their normal waking time, participants recorded their state in the Parkinson's Disease Diary (PD Diary) for 2 consecutive days prior to study visits. "On" time is defined as periods of good motor symptom control. The daily "On" and "Off" times were normalized to a typical waking day (16 hours) to account for different sleep patterns across participants. Baseline value is defined as the average of normalized "On" time with troublesome dyskinesia collected over the 2 PD Diary days before the Enrollment visit. Negative changes from Baseline indicate improvement.
Average Daily Normalized "On" Time Without Troublesome Dyskinesia: Change From Baseline to End of Study
Upon awakening and every 30 minutes during their normal waking time, participants recorded their state in the Parkinson's Disease Diary (PD Diary) for 2 consecutive days prior to study visits. "On" time is defined as periods of good motor symptom control. The daily "On" and "Off" times were normalized to a typical waking day (16 hours) to account for different sleep patterns across participants. Baseline value is defined as the average of normalized "On" time without troublesome dyskinesia collected over the 2 PD Diary days before the Enrollment visit. Positive changes from Baseline indicate improvement.
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I Score: Change From Baseline to End of Study
The Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is an investigator-used rating tool to follow the longitudinal course of Parkinson's Disease (PD). Part I assesses the participant's non-motor aspects of experiences of daily living (nM-EDL) with 13 questions. (The numeric score for each question is between 0-4; 0=Normal,1=Slight,2=Mild,3=Moderate,4=Severe). Part I scores range from 0 to 52, with higher scores indicating more severe symptoms of PD. Negative changes from Baseline indicate improvement.
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II Score: Change From Baseline to End of Study
The Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is an investigator-used rating tool to follow the longitudinal course of Parkinson's Disease (PD). Part II assesses the participant's motor experiences of daily living (M-EDL) with 13 questions. (The numeric score for each question is between 0-4; 0=Normal,1=Slight,2=Mild,3=Moderate,4=Severe). Part II scores range from 0 to 52, with higher scores indicating more severe symptoms of PD. Negative changes from Baseline indicate improvement.
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Score: Change From Baseline to End of Study
The Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is an investigator-used rating tool to follow the longitudinal course of Parkinson's Disease (PD). Part III assesses the participant's motor examination (including Hoehn and Yahr stage) with 33 questions. (The numeric score for each question is between 0-4; 0=Normal,1=Slight,2=Mild,3=Moderate,4=Severe). Part III scores range from 0 to 132, with higher scores indicating more severe symptoms of PD. Negative changes from Baseline indicate improvement.
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV Score: Change From Baseline to End of Study
The Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is an investigator-used rating tool to follow the longitudinal course of Parkinson's Disease (PD). Part IV assesses the participant's motor complications with 6 questions. (The numeric score for each question is between 0-4; 0=Normal,1=Slight,2=Mild,3=Moderate,4=Severe). Part IV scores range from 0 to 24, with higher scores indicating more severe symptoms of PD. Negative changes from Baseline indicate improvement.
Sleep Symptoms as Assessed by the Parkinson's Disease Sleep Scale-2 (PDSS-2) Total Score: Change From Baseline to End of Study
The PDSS-2 consists of 15 questions that evaluate motor and non-motor symptoms at night and upon wakening, as well as disturbed sleep grouped into 3 domains: motor symptoms at night (5 items), Parkinson's Disease (PD) symptoms at night (5 items), and disturbed sleep (5 items). The frequency is assessed for the 15 sleep problems based on a 5-point Likert-type scale (ranging from 0 [never] to 4 [very often] with the exception of Question 1 score ranging from 0 [very often] to 4 [never]). Scores are calculated for each of the 3 domains as well as a total score. The PDSS-2 domain scores range from 0 to 20 and the total score is a sum of the 3 domains and ranges from 0 to 60. Higher scores indicate higher frequency and more severe impact of PD on sleep. Negative changes indicate improvement from Baseline.
Quality of Life Assessed by the Parkinson's Disease Questionnaire-39 Items (PDQ-39) Summary Index Score: Change From Baseline to End of Study
The Parkinson's Disease Questionnaire (PDQ-39) is a disease-specific instrument designed to measure aspects of health that are relevant to participants with Parkinson's Disease (PD), and which may not be included in general health status questionnaires. Each item is scored on the following 5-point scale: 0 = never, 1 = occasionally, 2 = sometimes, 3 = often, 4 = always (or cannot do at all, if applicable). Higher scores are consistently associated with more severe symptoms of the disease such as tremors and stiffness. The results can be presented in either domain scores or as a summary index score. The full range of the PDQ-39 summary index score is from 0 (no patient-related symptoms/quality of life unaffected) to 100 (highest patient-related symptoms/low quality of life). Negative changes indicate improvement from Baseline.
The EuroQol 5-Dimension Questionnaire (EQ-5D-5L) Quality of Life Summary Index: Change From Baseline to End of Study
The EuroQol 5-dimension questionnaire (EQ-5D-5L) is a standardized non-disease specific instrument for describing and valuing health-related quality of life. The EQ-5D-5L descriptive system comprises 5 dimensions of health (mobility, self -care, usual activities, pain/discomfort, and anxiety/depression) to describe the participant's current health state. Each dimension comprises 5 levels with corresponding numeric scores, where 1 indicates no problems, and 5 indicates extreme problems. The health status is converted to an index value using the country-specific weighted scoring algorithm for the United States (US). The summary index value for the US ranges from a worst score of -0.109 to a best score of 1. An increase in the EQ-5D-5L total score indicates improvement.

Full Information

First Posted
December 18, 2018
Last Updated
September 27, 2023
Sponsor
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT03781167
Brief Title
A Study to Evaluate the Safety and Tolerability of ABBV-951 in Subjects With Parkinson's Disease (PD)
Official Title
A 52-Week, Open-label, Single-arm Study to Evaluate the Safety and Tolerability of 24-hour Daily Exposure of Continuous Subcutaneous Infusion of ABBV-951 in Subjects With Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
April 29, 2019 (Actual)
Primary Completion Date
August 17, 2022 (Actual)
Study Completion Date
August 17, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study was to assess the safety and tolerability of ABBV-951 (Foslevodopa/Foscarbidopa) in participants with Parkinson's disease (PD). This was a single-arm study with preplanned analyses conducted by dose subgroup (Low Dose or High Dose) based on the modal total daily dose (most frequent dose) over the treatment period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease (PD)
Keywords
Parkinson's Disease (PD), ABBV-951, Levodopa/Carbidopa

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
244 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ABBV-951 Low Dose Subgroup
Arm Type
Experimental
Arm Description
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was < 2530 mg of Foslevodopa/day were analyzed as the Low Dose Subgroup.
Arm Title
ABBV-951 High Dose Subgroup
Arm Type
Experimental
Arm Description
After a 4-week Optimization Period, participants continued receiving ABBV-951 by continuous subcutaneous infusion (CSCI) during the 48-week Maintenance Period. Participants whose modal total daily dose (most frequent dose) over the entire study was ≥ 2530 mg of Foslevodopa/day were analyzed as the High Dose Subgroup.
Intervention Type
Drug
Intervention Name(s)
ABBV-951
Other Intervention Name(s)
Foslevodopa/Foscarbidopa
Intervention Description
Solution for continuous subcutaneous infusion (CSCI)
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events
Description
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.
Time Frame
From first dose of study drug until 30 days following last dose of study drug (up to 480 days)
Title
Number of Participants With Adverse Events of Special Interest
Description
Treatment emergent adverse events of special interest are defined as any adverse event of infusion site infections, infusion site reactions, hallucinations/psychosis, falls and associated injuries, polyneuropathy (peripheral neuropathy), weight loss, or somnolence from the first dose of study drug until 30 days following last dose of study drug.
Time Frame
From first dose of study drug until 30 days following last dose of study drug (up to 480 days)
Title
Number of Participants With Numeric Grade Equal to or Higher Than 5 and With Letter Grade Equal to or Higher Than D on the Infusion Site Evaluation Scale
Description
Skin tolerability was assessed using the Infusion Site Evaluation Scale, a 2-part numeric (0-7) and letter (A-G) grade scale, where a notable skin reaction is defined as a reaction with a numeric grade of 6 or 7 or a letter grade of D, E, F, or G. Any observation of infusion site reaction with irritation criteria > 2 or > C was recorded as an adverse event (AE).
Time Frame
Day 1, Day 2, Week 1, Week 2, Week 3, Week 4, Week 6, Week 13, Week 26, Week 39, and Week 52
Title
Hematocrit (Hematology): Change From Baseline to End of Study
Description
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time Frame
Baseline, Weeks 6, 26, 39, and 52
Title
Hemoglobin (Hematology): Change From Baseline to End of Study
Description
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time Frame
Baseline, Weeks 6, 26, 39, and 52
Title
Red Blood Cell (RBC) Count (Hematology): Change From Baseline to End of Study
Description
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time Frame
Baseline, Weeks 6, 26, 39, and 52
Title
White Blood Cell (WBC) Count (Hematology): Change From Baseline to End of Study
Description
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time Frame
Baseline, Weeks 6, 26, 39, and 52
Title
Neutrophils (Hematology): Change From Baseline to End of Study
Description
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time Frame
Baseline, Weeks 6, 26, 39, and 52
Title
Lymphocytes (Hematology): Change From Baseline to End of Study
Description
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time Frame
Baseline, Weeks 6, 26, 39, and 52
Title
Monocytes (Hematology): Change From Baseline to End of Study
Description
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time Frame
Baseline, Weeks 6, 26, 39, and 52
Title
Absolute Platelet Count (Hematology): Change From Baseline to End of Study
Description
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time Frame
Baseline, Weeks 6, 26, 39, and 52
Title
Mean Corpuscular Hemoglobin (Hematology): Change From Baseline to End of Study
Description
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time Frame
Baseline, Weeks 6, 26, 39, and 52
Title
Mean Corpuscular Volume Concentration (MCHC) (Hematology): Change From Baseline to End of Study
Description
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time Frame
Baseline, Weeks 6, 26, 39, and 52
Title
Prothrombin Time (PT) (Hematology): Change From Baseline to End of Study
Description
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time Frame
Baseline, Weeks 6, 26, 39, and 52
Title
Activated Partial Thromboplastin Time (Hematology): Change From Baseline to End of Study
Description
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time Frame
Baseline, Weeks 6, 26, 39, and 52
Title
Blood Urea Nitrogen (BUN) (Clinical Chemistry): Change From Baseline to End of Study
Description
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time Frame
Baseline, Weeks 6, 26, 39, and 52
Title
Creatinine (Clinical Chemistry): Change From Baseline to End of Study
Description
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time Frame
Baseline, Weeks 6, 26, 39, and 52
Title
Creatine Phosphokinase (Clinical Chemistry): Change From Baseline to End of Study
Description
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time Frame
Baseline, Weeks 6, 26, 39, and 52
Title
Total Bilirubin (Clinical Chemistry): Change From Baseline to End of Study
Description
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time Frame
Baseline, Weeks 6, 26, 39, and 52
Title
Serum Alanine Aminotransferase (Clinical Chemistry): Change From Baseline to End of Study
Description
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time Frame
Baseline, Weeks 6, 26, 39, and 52
Title
Serum Aspartate Aminotransferase (Clinical Chemistry): Change From Baseline to End of Study
Description
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time Frame
Baseline, Weeks 6, 26, 39, and 52
Title
Serum Lactate Dehydrogenase (LDH) (Clinical Chemistry): Change From Baseline to End of Study
Description
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time Frame
Baseline, Weeks 6, 26, 39, and 52
Title
Gamma-glutamyl Transferase (Clinical Chemistry): Change From Baseline to End of Study
Description
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time Frame
Baseline, Weeks 6, 26, 39, and 52
Title
Alkaline Phosphatase (Clinical Chemistry): Change From Baseline to End of Study
Description
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time Frame
Baseline, Weeks 6, 26, 39, and 52
Title
Sodium (Clinical Chemistry): Change From Baseline to End of Study
Description
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time Frame
Baseline, Weeks 6, 26, 39, and 52
Title
Potassium (Clinical Chemistry): Change From Baseline to End of Study
Description
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time Frame
Baseline, Weeks 6, 26, 39, and 52
Title
Calcium (Clinical Chemistry): Change From Baseline to End of Study
Description
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time Frame
Baseline, Weeks 6, 26, 39, and 52
Title
Inorganic Phosphorus (Clinical Chemistry): Change From Baseline to End of Study
Description
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time Frame
Baseline, Weeks 6, 26, 39, and 52
Title
Uric Acid (Clinical Chemistry): Change From Baseline to End of Study
Description
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time Frame
Baseline, Weeks 6, 26, 39, and 52
Title
Total Cholesterol (Clinical Chemistry): Change From Baseline to End of Study
Description
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time Frame
Baseline, Weeks 6, 26, 39, and 52
Title
Albumin (Clinical Chemistry): Change From Baseline to End of Study
Description
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time Frame
Baseline, Weeks 6, 26, 39, and 52
Title
Glucose (Clinical Chemistry): Change From Baseline to End of Study
Description
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time Frame
Baseline, Weeks 6, 26, 39, and 52
Title
Sodium Bicarbonate/CO2 (Clinical Chemistry): Change From Baseline to End of Study
Description
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time Frame
Baseline, Weeks 6, 26, 39, and 52
Title
Magnesium (Clinical Chemistry): Change From Baseline to End of Study
Description
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time Frame
Baseline, Weeks 6, 26, 39, and 52
Title
Creatinine Clearance (Clinical Chemistry): Change From Baseline to End of Study
Description
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time Frame
Baseline, Weeks 6, 26, 39, and 52
Title
Homocysteine (Clinical Chemistry): Change From Baseline to End of Study
Description
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time Frame
Baseline, Weeks 6, 26, and 52
Title
Vitamin B6 (Clinical Chemistry): Change From Baseline to End of Study
Description
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time Frame
Baseline, Weeks 6, 26, and 52
Title
Vitamin B12 (Clinical Chemistry): Change From Baseline to End of Study
Description
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time Frame
Baseline, Weeks 6, 26, and 52
Title
pH (Urinalysis): Change From Baseline to End of Study
Description
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time Frame
Baseline, Weeks 6, 26, 39, and 52
Title
Specific Gravity (Urinalysis): Change From Baseline to End of Study
Description
Samples for clinical laboratory tests were collected at study visits, and a certified central laboratory was used to process the samples and provide results.
Time Frame
Baseline, Weeks 6, 26, 39, and 52
Title
Orthostatic Systolic Blood Pressure (Vital Signs): Change From Baseline to End of Study
Description
Orthostatic blood pressure was measured after the participant had been supine (lying down with their face up) for at least 5 minutes and then, after the participant had been standing for 2 minutes. When vital sign measurements were scheduled at the same time as a blood collection, vital sign measurements were obtained prior to blood collection.
Time Frame
Baseline, Weeks 1, 6, 26, and 52 (orthostatic and standing); Baseline, Weeks 2, 4, 13, and 39 (supine)
Title
Orthostatic Diastolic Blood Pressure (Vital Signs): Change From Baseline to End of Study
Description
Orthostatic blood pressure was measured after the participant had been supine (lying down with their face up) for at least 5 minutes and then, after the participant had been standing for 2 minutes. When vital sign measurements were scheduled at the same time as a blood collection, vital sign measurements were obtained prior to blood collection.
Time Frame
Baseline, Weeks 1, 6, 26, and 52 (orthostatic and standing); Baseline, Weeks 2, 4, 13, and 39 (supine)
Title
Orthostatic Pulse Rate (Vital Signs): Change From Baseline to End of Study
Description
Orthostatic pulse rate was measured after the participant had been supine (lying down with their face up) for at least 5 minutes and then, after the participant had been standing for 2 minutes. When vital sign measurements were scheduled at the same time as a blood collection, vital sign measurements were obtained prior to blood collection.
Time Frame
Baseline, Weeks 1, 6, 26, and 52 (orthostatic and standing); Baseline, Weeks 2, 4, 13, and 39 (supine)
Title
Electrocardiogram (ECG) Mean Heart Rate: Change From Baseline to End of Study
Description
12-lead electrocardiograms (ECGs) were recorded at study visits after the participant had been supine for at least 5 minutes. Participants were instructed to remain stationary (no talking, laughing, deep breathing, sleeping, or swallowing) for approximately 10 seconds during the ECG recording. When an ECG was recorded at a time near that of a blood collection, the ECG was obtained prior to the blood collection. ECGs on Day 1 were recorded after initiation of the continuous subcutaneous infusion (CSCI) of ABBV-951 prior to the end of the study visit.
Time Frame
Baseline, Day 1 (postdose), Weeks 6 and 52
Title
Electrocardiogram (ECG) Aggregate PR Interval: Change From Baseline to End of Study
Description
12-lead electrocardiograms (ECGs) were recorded at study visits after the participant had been supine for at least 5 minutes. Participants were instructed to remain stationary (no talking, laughing, deep breathing, sleeping, or swallowing) for approximately 10 seconds during the ECG recording. When an ECG was recorded at a time near that of a blood collection, the ECG was obtained prior to the blood collection. ECGs on Day 1 were recorded after initiation of the continuous subcutaneous infusion (CSCI) of ABBV-951 prior to the end of the study visit.
Time Frame
Baseline, Day 1 (postdose), Weeks 6 and 52
Title
Electrocardiogram (ECG) Aggregate QRS Duration: Change From Baseline to End of Study
Description
12-lead electrocardiograms (ECGs) were recorded at study visits after the participant had been supine for at least 5 minutes. Participants were instructed to remain stationary (no talking, laughing, deep breathing, sleeping, or swallowing) for approximately 10 seconds during the ECG recording. When an ECG was recorded at a time near that of a blood collection, the ECG was obtained prior to the blood collection. ECGs on Day 1 were recorded after initiation of the continuous subcutaneous infusion (CSCI) of ABBV-951 prior to the end of the study visit.
Time Frame
Baseline, Day 1 (postdose), Weeks 6 and 52
Title
Electrocardiogram (ECG) Aggregate QT Interval: Change From Baseline to End of Study
Description
12-lead electrocardiograms (ECGs) were recorded at study visits after the participant had been supine for at least 5 minutes. Participants were instructed to remain stationary (no talking, laughing, deep breathing, sleeping, or swallowing) for approximately 10 seconds during the ECG recording. When an ECG was recorded at a time near that of a blood collection, the ECG was obtained prior to the blood collection. ECGs on Day 1 were recorded after initiation of the continuous subcutaneous infusion (CSCI) of ABBV-951 prior to the end of the study visit.
Time Frame
Baseline, Day 1 (postdose), Weeks 6 and 52
Title
Electrocardiogram (ECG) Aggregate QTcB Interval: Change From Baseline to End of Study
Description
12-lead electrocardiograms (ECGs) were recorded at study visits after the participant had been supine for at least 5 minutes. Participants were instructed to remain stationary (no talking, laughing, deep breathing, sleeping, or swallowing) for approximately 10 seconds during the ECG recording. When an ECG was recorded at a time near that of a blood collection, the ECG was obtained prior to the blood collection. ECGs on Day 1 were recorded after initiation of the continuous subcutaneous infusion (CSCI) of ABBV-951 prior to the end of the study visit.
Time Frame
Baseline, Day 1 (postdose), Weeks 6 and 52
Title
Electrocardiogram (ECG) Aggregate QTcF Interval: Change From Baseline to End of Study
Description
12-lead electrocardiograms (ECGs) were recorded at study visits after the participant had been supine for at least 5 minutes. Participants were instructed to remain stationary (no talking, laughing, deep breathing, sleeping, or swallowing) for approximately 10 seconds during the ECG recording. When an ECG was recorded at a time near that of a blood collection, the ECG was obtained prior to the blood collection. ECGs on Day 1 were recorded after initiation of the continuous subcutaneous infusion (CSCI) of ABBV-951 prior to the end of the study visit.
Time Frame
Baseline, Day 1 (postdose), Weeks 6 and 52
Title
Electrocardiogram (ECG) Aggregate RR Interval: Change From Baseline to End of Study
Description
12-lead electrocardiograms (ECGs) were recorded at study visits after the participant had been supine for at least 5 minutes. Participants were instructed to remain stationary (no talking, laughing, deep breathing, sleeping, or swallowing) for approximately 10 seconds during the ECG recording. When an ECG was recorded at a time near that of a blood collection, the ECG was obtained prior to the blood collection. ECGs on Day 1 were recorded after initiation of the continuous subcutaneous infusion (CSCI) of ABBV-951 prior to the end of the study visit.
Time Frame
Baseline, Day 1 (postdose), Weeks 6 and 52
Secondary Outcome Measure Information:
Title
Average Daily Normalized "Off" Time: Change From Baseline to End of Study
Description
Upon awakening and every 30 minutes during their normal waking time, participants recorded their state in the Parkinson's Disease Diary (PD Diary) for 2 consecutive days prior to study visits. "Off" time is defined as periods of poor mobility, tremor, slowness, and stiffness. The daily "On" and "Off" times were normalized to a typical waking day (16 hours) to account for different sleep patterns across participants. When "Off" was the first morning symptom upon awakening, this was considered morning akinesia in this study. Baseline value is defined as the average of normalized "Off" time collected over the 2 PD Diary days before the Enrollment visit. Negative changes from Baseline indicate improvement.
Time Frame
Baseline, Weeks 1, 6, 13, 26, 39, and 52
Title
Average Daily Normalized "On" Time With Troublesome Dyskinesia: Change From Baseline to End of Study
Description
Upon awakening and every 30 minutes during their normal waking time, participants recorded their state in the Parkinson's Disease Diary (PD Diary) for 2 consecutive days prior to study visits. "On" time is defined as periods of good motor symptom control. The daily "On" and "Off" times were normalized to a typical waking day (16 hours) to account for different sleep patterns across participants. Baseline value is defined as the average of normalized "On" time with troublesome dyskinesia collected over the 2 PD Diary days before the Enrollment visit. Negative changes from Baseline indicate improvement.
Time Frame
Baseline, Weeks 1, 6, 13, 26, 39, and 52
Title
Average Daily Normalized "On" Time Without Troublesome Dyskinesia: Change From Baseline to End of Study
Description
Upon awakening and every 30 minutes during their normal waking time, participants recorded their state in the Parkinson's Disease Diary (PD Diary) for 2 consecutive days prior to study visits. "On" time is defined as periods of good motor symptom control. The daily "On" and "Off" times were normalized to a typical waking day (16 hours) to account for different sleep patterns across participants. Baseline value is defined as the average of normalized "On" time without troublesome dyskinesia collected over the 2 PD Diary days before the Enrollment visit. Positive changes from Baseline indicate improvement.
Time Frame
Baseline, Weeks 1, 6, 13, 26, 39, and 52
Title
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I Score: Change From Baseline to End of Study
Description
The Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is an investigator-used rating tool to follow the longitudinal course of Parkinson's Disease (PD). Part I assesses the participant's non-motor aspects of experiences of daily living (nM-EDL) with 13 questions. (The numeric score for each question is between 0-4; 0=Normal,1=Slight,2=Mild,3=Moderate,4=Severe). Part I scores range from 0 to 52, with higher scores indicating more severe symptoms of PD. Negative changes from Baseline indicate improvement.
Time Frame
Baseline, Day 2, Weeks 1, 2, 3, 4, 6, 13, 26, 39, and 52
Title
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II Score: Change From Baseline to End of Study
Description
The Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is an investigator-used rating tool to follow the longitudinal course of Parkinson's Disease (PD). Part II assesses the participant's motor experiences of daily living (M-EDL) with 13 questions. (The numeric score for each question is between 0-4; 0=Normal,1=Slight,2=Mild,3=Moderate,4=Severe). Part II scores range from 0 to 52, with higher scores indicating more severe symptoms of PD. Negative changes from Baseline indicate improvement.
Time Frame
Baseline, Day 2, Weeks 1, 2, 3, 4, 6, 13, 26, 39, and 52
Title
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Score: Change From Baseline to End of Study
Description
The Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is an investigator-used rating tool to follow the longitudinal course of Parkinson's Disease (PD). Part III assesses the participant's motor examination (including Hoehn and Yahr stage) with 33 questions. (The numeric score for each question is between 0-4; 0=Normal,1=Slight,2=Mild,3=Moderate,4=Severe). Part III scores range from 0 to 132, with higher scores indicating more severe symptoms of PD. Negative changes from Baseline indicate improvement.
Time Frame
Baseline, Day 2, Weeks 1, 2, 3, 4, 6, 13, 26, 39, and 52
Title
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV Score: Change From Baseline to End of Study
Description
The Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is an investigator-used rating tool to follow the longitudinal course of Parkinson's Disease (PD). Part IV assesses the participant's motor complications with 6 questions. (The numeric score for each question is between 0-4; 0=Normal,1=Slight,2=Mild,3=Moderate,4=Severe). Part IV scores range from 0 to 24, with higher scores indicating more severe symptoms of PD. Negative changes from Baseline indicate improvement.
Time Frame
Baseline, Day 2, Weeks 1, 2, 3, 4, 6, 13, 26, 39, and 52
Title
Sleep Symptoms as Assessed by the Parkinson's Disease Sleep Scale-2 (PDSS-2) Total Score: Change From Baseline to End of Study
Description
The PDSS-2 consists of 15 questions that evaluate motor and non-motor symptoms at night and upon wakening, as well as disturbed sleep grouped into 3 domains: motor symptoms at night (5 items), Parkinson's Disease (PD) symptoms at night (5 items), and disturbed sleep (5 items). The frequency is assessed for the 15 sleep problems based on a 5-point Likert-type scale (ranging from 0 [never] to 4 [very often] with the exception of Question 1 score ranging from 0 [very often] to 4 [never]). Scores are calculated for each of the 3 domains as well as a total score. The PDSS-2 domain scores range from 0 to 20 and the total score is a sum of the 3 domains and ranges from 0 to 60. Higher scores indicate higher frequency and more severe impact of PD on sleep. Negative changes indicate improvement from Baseline.
Time Frame
Baseline, Weeks 6, 13, 26, 39, and 52
Title
Quality of Life Assessed by the Parkinson's Disease Questionnaire-39 Items (PDQ-39) Summary Index Score: Change From Baseline to End of Study
Description
The Parkinson's Disease Questionnaire (PDQ-39) is a disease-specific instrument designed to measure aspects of health that are relevant to participants with Parkinson's Disease (PD), and which may not be included in general health status questionnaires. Each item is scored on the following 5-point scale: 0 = never, 1 = occasionally, 2 = sometimes, 3 = often, 4 = always (or cannot do at all, if applicable). Higher scores are consistently associated with more severe symptoms of the disease such as tremors and stiffness. The results can be presented in either domain scores or as a summary index score. The full range of the PDQ-39 summary index score is from 0 (no patient-related symptoms/quality of life unaffected) to 100 (highest patient-related symptoms/low quality of life). Negative changes indicate improvement from Baseline.
Time Frame
Baseline, Weeks 6, 13, 26, 39, and 52
Title
The EuroQol 5-Dimension Questionnaire (EQ-5D-5L) Quality of Life Summary Index: Change From Baseline to End of Study
Description
The EuroQol 5-dimension questionnaire (EQ-5D-5L) is a standardized non-disease specific instrument for describing and valuing health-related quality of life. The EQ-5D-5L descriptive system comprises 5 dimensions of health (mobility, self -care, usual activities, pain/discomfort, and anxiety/depression) to describe the participant's current health state. Each dimension comprises 5 levels with corresponding numeric scores, where 1 indicates no problems, and 5 indicates extreme problems. The health status is converted to an index value using the country-specific weighted scoring algorithm for the United States (US). The summary index value for the US ranges from a worst score of -0.109 to a best score of 1. An increase in the EQ-5D-5L total score indicates improvement.
Time Frame
Baseline, Weeks 6, 13, 26, 39, and 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants with diagnosis of idiopathic Parkinson's Disease (PD) that is levodopa-responsive Participants must be judged by the investigator to be inadequately controlled by current therapy, have recognizable/identifiable "Off" and "On" states (motor fluctuations), and have a minimum of 2.5 hours of "Off" time per day Exclusion Criteria: Participant is cognitively impaired and is not able to safely and effectively manage the drug delivery system and the diaries and is not able to adhere to the study Participant is considered by the investigator to be an unsuitable candidate to receive ABBV-951 for any reason
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham - Main /ID# 207996
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Banner Sun Health Res Inst /ID# 208811
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85351
Country
United States
Facility Name
The Parkinson's & Movement Disorder Institute - Fountain Valley /ID# 216126
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
University of Colorado Hospital /ID# 207968
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Parkinson's Disease and Movement Disorders Center of Boca Raton /ID# 207677
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Northwestern University Feinberg School of Medicine /ID# 208812
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611-2927
Country
United States
Facility Name
Indiana Clinical Research Cent /ID# 207952
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Univ Kansas Med Ctr /ID# 208963
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
University of Kentucky Chandler Medical Center /ID# 207603
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Massachusetts General Hospital /ID# 207993
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Health Partners /ID# 207950
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55130-2400
Country
United States
Facility Name
University of Missouri /ID# 209043
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65203
Country
United States
Facility Name
Washington University-School of Medicine /ID# 207525
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center /ID# 207972
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Wake Radiology UNC REX Healthcare - Raleigh Office /ID# 209784
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Legacy Medical Group - Neurology /ID# 208031
City
Portland
State/Province
Oregon
ZIP/Postal Code
97232-2003
Country
United States
Facility Name
Prisma Health Cancer Institute-Faris Road /ID# 207650
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605-4255
Country
United States
Facility Name
Neurology Consultants of Dallas - LBJ Fwy /ID# 207619
City
Dallas
State/Province
Texas
ZIP/Postal Code
75243-1188
Country
United States
Facility Name
Baylor College of Medicine /ID# 207620
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4202
Country
United States
Facility Name
Central Texas Neurology Consul /ID# 216918
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78681
Country
United States
Facility Name
Univ Texas HSC San Antonio /ID# 208958
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229-3901
Country
United States
Facility Name
Booth Gardner Parkinson's Care Center /ID# 208026
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98034-3029
Country
United States
Facility Name
Inland Northwest Research /ID# 208122
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202-1342
Country
United States
Facility Name
Medical College of Wisconsin /ID# 207999
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226-3522
Country
United States
Facility Name
Concord Repatriation General Hospital /ID# 207628
City
Concord
State/Province
New South Wales
ZIP/Postal Code
2139
Country
Australia
Facility Name
Westmead Hospital /ID# 207633
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Royal Adelaide Hospital /ID# 207634
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Alfred Health /ID# 207632
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Perron Institute /ID# 207627
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Universitair Ziekenhuis Leuven /ID# 209058
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium
Facility Name
AZ Sint-Jan Brugge /ID# 208178
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
Groupe Sante CHC - Clinique du MontLegia /ID# 208177
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
University of Calgary - Movement Disorders Clinic /ID# 207342
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N1
Country
Canada
Facility Name
Centre de Recherche St-Louis /ID# 207344
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1W 4R4
Country
Canada
Facility Name
Bispebjerg and Frederiksberg Hospital /ID# 207669
City
Copenhagen NV
State/Province
Hovedstaden
ZIP/Postal Code
2400
Country
Denmark
Facility Name
Aarhus University Hospital /ID# 207668
City
Aarhus N
State/Province
Midtjylland
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Odense University Hospital /ID# 207871
City
Odense C
State/Province
Syddanmark
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Universitaetsklinikum Ulm /ID# 208602
City
Ulm
State/Province
Baden-Wuerttemberg
ZIP/Postal Code
89081
Country
Germany
Facility Name
Kliniken Beelitz GmbH /ID# 208600
City
Beelitz-Heilstaetten
ZIP/Postal Code
14547
Country
Germany
Facility Name
InnKlinikum Haag /ID# 208601
City
Haag
ZIP/Postal Code
83527
Country
Germany
Facility Name
IRCCS Centro Neurolesi Bonino Pulejo /ID# 207975
City
Messina
ZIP/Postal Code
98124
Country
Italy
Facility Name
Fondazione IRCCS Istituto Neurologico Carlo Besta /ID# 207955
City
Milan
ZIP/Postal Code
20133
Country
Italy
Facility Name
Azienda Ospedaliera di Padova /ID# 208077
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
National Hospital Organization Asahikawa Medical Center /ID# 210914
City
Asahikawa-shi
State/Province
Hokkaido
ZIP/Postal Code
070-8644
Country
Japan
Facility Name
National Hospital Organization Utano National Hospital /ID# 210912
City
Kyoto-shi
State/Province
Kyoto
ZIP/Postal Code
616-8255
Country
Japan
Facility Name
Osaka University Hospital /ID# 210913
City
Suita-shi
State/Province
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
Juntendo University Hospital /ID# 210915
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8431
Country
Japan
Facility Name
National Center of Neurology and Psychiatry /ID# 210911
City
Kodaira-shi
State/Province
Tokyo
ZIP/Postal Code
187-8551
Country
Japan
Facility Name
Erasmus Medisch Centrum /ID# 208168
City
Rotterdam
State/Province
Zuid-Holland
ZIP/Postal Code
3015 GD
Country
Netherlands
Facility Name
St. Antonius Ziekenhuis /ID# 208529
City
Nieuwegein
ZIP/Postal Code
3435 CM
Country
Netherlands
Facility Name
City Clinical Hospital #40 /ID# 216301
City
Sestroretsk
State/Province
Sankt-Peterburg
ZIP/Postal Code
197706
Country
Russian Federation
Facility Name
Academician I.P. Pavlov First St. Petersburg State Medical University /ID# 216303
City
St. Petersburg
State/Province
Sankt-Peterburg
ZIP/Postal Code
197101
Country
Russian Federation
Facility Name
Hospital General Universitario de Elche /ID# 209777
City
Elche
State/Province
Alicante
ZIP/Postal Code
03203
Country
Spain
Facility Name
Hospital Universitario de Bellvitge /ID# 209539
City
L'Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital Universitario A Coruna - CHUAC /ID# 212147
City
A Coruna
ZIP/Postal Code
15006
Country
Spain
Facility Name
Hospital Santa Creu i Sant Pau /ID# 208240
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Hospital Universitario Virgen de las Nieves /ID# 208242
City
Granada
ZIP/Postal Code
18014
Country
Spain
Facility Name
Hospital Universitario Ramon y Cajal /ID# 208241
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio /ID# 208239
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Skane University Hospital Lund /ID# 207811
City
Lund
State/Province
Skane Lan
ZIP/Postal Code
SE 221 41
Country
Sweden
Facility Name
Centrum for neurologi /ID# 207716
City
Stockholm
State/Province
Stockholms Lan
ZIP/Postal Code
113 65
Country
Sweden
Facility Name
Sahlgrenska University Hospital /ID# 207718
City
Gothenburg
State/Province
Vastra Gotalands Lan
ZIP/Postal Code
413 46
Country
Sweden
Facility Name
NHS Tayside /ID# 209242
City
Dundee
State/Province
Scotland
ZIP/Postal Code
DD2 1UB
Country
United Kingdom
Facility Name
King's College Hospital NHS Foundation Trust /ID# 208413
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
University Hospital Plymouth NHS Trust /ID# 208447
City
Plymouth
ZIP/Postal Code
PL6 5FP
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD Sharing Time Frame
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
IPD Sharing Access Criteria
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
IPD Sharing URL
https://vivli.org/ourmember/abbvie/

Learn more about this trial

A Study to Evaluate the Safety and Tolerability of ABBV-951 in Subjects With Parkinson's Disease (PD)

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