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Safety/Efficacy Study of Levodopa-Carbidopa Intestinal Gel in Parkinson's Subjects

Primary Purpose

Dyskinesias, Parkinson's Disease, Severe Motor Fluctuations

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Levodopa-carbidopa intestinal gel

CADD-Legacy® 1400 ambulatory infusion pump

PEG tube

J-tube

About this trial

This is an interventional treatment trial for Dyskinesias focused on measuring carbidopa, severe motor fluctuations, intestinal gel, levodopa, efficacy, levodopa carbidopa intestinal gel, dyskinesia, Parkinson's Disease, Duodopa, levodopa-carbidopa, DUOPA

Eligibility Criteria

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

Inclusion Criteria: Idiopathic Parkinson's disease (PD) according to United Kingdon Parkinson's Disease Society (UKPDS) Brain Bank Criteria Levodopa-responsive with severe motor fluctuations Completion of protocol S187.3.001 (NCT00357994) or S187.3.002 (NCT00660387) and continue to meet the inclusion criteria for the preceding study Exclusion Criteria: Patients with medically relevant abnormal findings (labs, electrocardiogram [ECG], physical examination, adverse events, psychiatric, neurological or behavioral disorders, etc.) at end of the double-blind phase (Week 12) of Study S187.3.001 (NCT00357994) or Study S187.3.002 (NCT00660387)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Levodopa-Carbidopa Intestinal Gel (LCIG)

Arm Description

All participants received LCIG, delivered through a percutaneous endoscopic gastrostomy with jejunal extension (PEG-J), administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the participant's optimized oral levodopa-carbidopa dose that the subject was receiving just prior to randomization in Study S187.3.001 (NCT00357994) or Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of either of these 2 previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.

Outcomes

Primary Outcome Measures

Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths and Discontinuations Due to AEs

AE=any untoward medical occurrence which does not necessarily have a causal relationship with this treatment. SAE=any untoward medical occurrence that: results in death; is life-threatening (an event in which the subject was at risk of death at the time of the event); requires inpatient hospitalization or prolongation of an existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or other important medical events. Treatment-emergent events (TEAE or TESAE)=those starting after the first dose of study drug. Severe=severity reported as 'severe' or missing. Possibly or Probably Treatment Related=drug-event relationship reported as 'possible', 'probable' or missing. Death=a fatal outcome of an SAE or AE.

Number of Participants With Device Complications

Complications of the infusion device were collected. Pump, intestinal tube, PEG, stoma, and other complications included (but were not limited to) device breakage, device leakage, device malfunction, device misuse, device occlusion, intentional and unintentional device removal by participant, complication of device insertion, device dislocation, device breakage, device dislocation, and device site reaction.

Number of Participants With Potentially Clinically Significant Values for Hematology Parameters

Terms abbreviated in the table include females (f) and males (m).

Number of Participants With Potentially Clinically Significant Values for Clinical Chemistry Parameters

Terms abbreviated in the table include upper limit of normal (ULN), male (m), and female (f).

Number of Participants With Potentially Clinically Significant Vital Sign Parameters

Terms abbreviated in the table include supine systolic blood pressure (SuSBP), standing systolic blood pressure (StSBP), orthostatic systolic blood pressure (OSBP), supine diastolic blood pressure (SuDBP), standing diastolic blood pressure (StDBP), orthostatic diastolic blood pressure (ODBP), supine pulse (SuP) in beats per minute (bpm), standing pulse (StP), and body temperature (Temp). Increase and decrease are signified by ↑ and ↓, respectively.

Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Parameters

Terms abbreviated in the table include heart rate (HR) in beats per minute (bpm), PR interval (PRI), QT interval corrected for heart rate using Bazett's formula (QTcB), and QT interval corrected for heart rate using Fridericia's formula (QTcF). Increase and decrease are signified by ↑ and ↓, respectively.

Number of Participants With Sleep Attacks at Baseline and Endpoint

To prospectively monitor for the possible development of sleep attacks, participants were asked if they had experienced any events in which they fell asleep suddenly or unexpectedly, including while engaged in some activity (e.g., eating/drinking, speaking, or driving) or at rest, with or without any previous warning of sleepiness.

Summary of Minnesota Impulsive Disorder Interview (MIDI) Assessment of Intense Impulsive Behavior at Baseline (BL) and Post-baseline (PBL)

The MIDI is a validated assessment of impulsive behavior consisting of a semistructured clinical interview assessing pathological gambling, trichotillomania (compulsive hair-pulling), kleptomania (compulsive stealing), pyromania (compulsive fire-setting), intermittent explosive disorder, compulsive buying, and compulsive sexual behavior.

Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score at Endpoint

The AIMS is an investigator-completed rating scale that has a total of 12 items rating involuntary movements of various areas of the participant's body. Items 1 through 10 are rated on a 5-point scale of severity from 0 (none), 1 (minimal), 2 (mild), 3 (moderate), to 4 (severe), and items 11 and 12 are yes/no questions concerning problems with teeth or dentures. The total AIMS score was calculated by summing items 1-10, with a possible range of 0-40; a negative change indicates improvement. The AIMS was to be performed at consistent times, when the subject was experiencing his/her worst "On" time (dyskinesia [involuntary muscle movement]).

Number of Participants With Confirmed Cases of Melanoma

A comprehensive assessment for the presence of melanoma was performed during the screening period and at early termination/end of study by a dermatologist experienced with the diagnosis of the condition. If a suspicious lesion was present, a biopsy was obtained for proper diagnosis.

Number of Participants With Clinically Significant Neurological Examination Findings

The neurologic examination was to be done during "On" time. The neurological examination assessed: cranial nerves - assessment of cranial nerves II - XII, excluding fundoscopic examination; motor system - assessment of tone, strength, and abnormal movements; sensory system - including light touch, pinprick, joint position, and vibratory sense; reflexes - assessment of deep tendon reflexes and plantar responses (Babinski sign); coordination - assessment of upper and lower extremities; gait - assessment of base and tandem gait; station - assessment of posture and stability.

Columbia-Suicide Severity Rating Scale (C-SSRS) Findings

The Columbia-Suicide Severity Rating Scale (C-SSRS) is a systematically administered instrument developed to track suicidal adverse events across a treatment study. The instrument is designed to assess suicidal behavior and ideation, track and assess all suicidal events, as well as the lethality of attempts. Suicidal ideation categories include the following: wish to be dead; nonspecific active suicidal thoughts; active suicidal ideation without intent to act; active suicidal ideation with some intent to act but no plan; active suicidal ideation with plan and intent. Suicidal behavior categories include the following: actual attempt; interrupted attempt; aborted attempt; preparatory acts or behavior; suicidal behavior; completed suicide.

Number of Participants Taking at Least 1 Concomitant Medication During the Study

Concomitant medications include medications started on or after the first open-label LCIG infusion as well as medications started prior to the first open-label infusion but continued during the study.

Secondary Outcome Measures

Change From Baseline in Average Daily "Off" Time at Endpoint

Based on the Parkinson's Disease Symptom Diary. "On" time is when PD symptoms are well controlled by the drug. "Off" time is when PD symptoms are not adequately controlled by the drug. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis. Negative change from baseline for "off" time indicates improvement.

Change From Baseline in Average Daily Normalized "On" Time With Troublesome Dyskinesia at Endpoint

Based on the Parkinson's Disease Symptom Diary. "On" time is when PD symptoms are well controlled by the drug. "Off" time is when PD symptoms are not adequately controlled by the drug. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis.

Change From Baseline in Average Daily "On" Time Without Troublesome Dyskinesia at Month 12

Based on the Parkinson's Disease Symptom Diary. "On" time is when PD symptoms are well controlled by the drug. "Off" time is when PD symptoms are not adequately controlled by the drug. "On" time without troublesome dyskinesia (involuntary muscle movement) is defined as "on" time without dyskinesia and "on" time with non-troublesome dyskinesia. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis. Positive change from Baseline for "on" time without troublesome dyskinesia indicates improvement.

Clinical Global Impression - Status (CGI-S) Score at Baseline and Clinical Global Impression - Improvement (CGI-I) Score at Endpoint

The CGI-S is a global assessment by the Investigator of current symptomatology and impact of illness on functioning. The ratings of the CGI-S are as follows: 1 = normal, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, and 7 = among the most extremely ill. The CGI-I is a global assessment by the Investigator of the change in clinical status since the start of treatment. The CGI-I ratings are as follows: 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse.

Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part I Score at Endpoint

The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part I Score is the sum of the answers to the 4 questions that comprise Part I, each of which are measured on a 5-point scale (0-4). The Part I score ranges from 0-16 and higher scores are associated with more disability.

Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score at Endpoint

The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part II score is the sum of the answers to the 13 questions that comprise Part II, each of which are measured on a 5-point scale (0-4). The Part II score ranges from 0-52 and higher scores are associated with more disability.

Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score at Endpoint

The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part III score is the sum of the 27 answers provided to the 14 Part III questions, each of which are measured on a 5-point scale (0-4). The Part III score ranges from 0-108 and higher scores are associated with more disability.

Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score at Endpoint

The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The total score is the sum of the responses to the 31 questions (44 answers) that comprise Parts I-III of the scale. The total score will range from 0-176, with 176 representing the worst (total) disability, and 0 representing no disability.

Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Score at Endpoint

The UPDRS is an Investigator-used rating tool to follow the longitudinal course of Parkinson's disease. The Part IV Score is the sum of the answers to the 11 questions that comprise Part IV, each of which are measured on a 5-point scale (0-4) or a 2-point scale (0 or 1). The Part IV score ranges from 0-23 and higher scores are associated with more disability.

Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Summary Index at Endpoint

The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. These include: mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. The PDQ-39 Summary Index is the sum of all answers divided by the highest score possible (i.e. number of answers multiplied by 4) which is multiplied by 100 to put the score on a 0-100 scale. Higher scores are associated with more severe symptoms.

Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Mobility Domain Score at Endpoint

The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Mobility (e.g., fear of falling when walking) includes 10 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.

Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Activities of Daily Living Domain Score at Endpoint

The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Activities of Daily Living (e.g., difficulty cutting food) includes 6 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.

Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Emotional Well-Being Domain Score at Endpoint

The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Emotional Well-being (e.g., feelings of isolation) includes 6 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.

Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Stigma Domain Score at Endpoint

The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Stigma (e.g., social embarrassment) consists of 4 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.

Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Social Support Domain Score at Endpoint

The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Social Support includes 3 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.

Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Cognition Domain Score at Endpoint

The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Cognition includes 4 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.

Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Communication Domain Score at Endpoint

The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Communication includes 3 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.

Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Bodily Discomfort Domain Score at Endpoint

The PDQ-39 is a self-administered questionnaire which comprises 39 items addressing 8 domains of health in Parkinson's disease patients. The PDQ-39 Domain: Bodily Discomfort includes 3 questions, each answered on a 5-point scale. The domain scores are calculated by first summing the answers to the questions in the domain. The sum is divided by the highest score possible (i.e., number of answers multiplied by 4) and the quotient is multiplied by 100 to put the score on a scale from 0 to 100, where lower scores indicate a better perceived health status. Higher scores are consistently associated with the more severe symptoms of the disease such as tremor and stiffness.

Change From Baseline in EuroQol Quality of Life Scale (EQ-5D) Summary Index at Endpoint

The EQ-5D is a participant answered questionnaire scoring 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by applying a formula that essentially attaches values (also called QOL weights or QOL utilities) to each of the levels in each dimension. EQ-5D Summary Index values range from -0.11 to 1.00 with positive change indicating improvement.

Change From Baseline in EuroQol Quality of Life Scale (EQ-5D) Visual Analogue Scale (VAS) at Endpoint

The EQ-5D VAS records the participant's self-rated health on a scale from 0-100 where 100 is the 'best imaginable health state' and 0 is the 'worst imaginable health state.'

Change From Baseline in Zarit Burden Interview (ZBI) Total Score at Endpoint

The ZBI is a 22-item questionnaire regarding the caregiver/subject relationship and evaluates the caregiver's health condition, psychological well-being, finances and social life. Each question is answered on a 5-point scale (0=never, 1=rarely, 2=sometimes, 3=quite frequently, and 4=nearly always). The caregiver burden is evaluated by the total score (range 0 to 88) obtained from the sum of the answers to the 22 questions. Higher scores are associated with a higher level of burden for the caregiver.

Full Information

NCT ID

NCT00360568

First Posted

August 3, 2006

Last Updated

January 12, 2015

Sponsor

AbbVie (prior sponsor, Abbott)

Collaborators

Quintiles, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00360568

Brief Title

Safety/Efficacy Study of Levodopa-Carbidopa Intestinal Gel in Parkinson's Subjects

Official Title

Open-Label, 12-Month Safety and Efficacy Study of Levodopa - Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Disease Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

January 2015

Overall Recruitment Status

Completed

Study Start Date

June 2009 (undefined)

Primary Completion Date

October 2012 (Actual)

Study Completion Date

October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AbbVie (prior sponsor, Abbott)

Collaborators

Quintiles, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Long term safety and efficacy (12 months) of levodopa-carbidopa intestinal gel.

Detailed Description

Study S187.3.003 (NCT00360568) is a Phase 3, 12-month, open-label, multicenter continuation treatment study of the safety, tolerability, and efficacy of levodopa-carbidopa intestinal gel (LCIG) in the treatment of participants with levodopa-responsive Parkinson's disease (PD) with persistent motor fluctuations despite optimized treatment with available PD medications. All participants received LCIG. Only participants who completed 12 weeks of double-blind, double-dummy treatment in Study S187.3.001 or S187.3.002 (NCT00357994/ NCT00660387) qualified for enrollment in this 12-month continuation treatment study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dyskinesias, Parkinson's Disease, Severe Motor Fluctuations

Keywords

carbidopa, severe motor fluctuations, intestinal gel, levodopa, efficacy, levodopa carbidopa intestinal gel, dyskinesia, Parkinson's Disease, Duodopa, levodopa-carbidopa, DUOPA

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

62 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Levodopa-Carbidopa Intestinal Gel (LCIG)

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Levodopa-carbidopa intestinal gel

Intervention Description

Infusion should be kept within a range of 0.5-10 mL/hour (10-200 mg levodopa/hour) and is usually 2-6 mL/hour (40-120 mg levodopa/hour).

Intervention Type

Device

Intervention Name(s)

CADD-Legacy® 1400 ambulatory infusion pump

Intervention Type

Device

Intervention Name(s)

PEG tube

Intervention Description

percutaneous endoscopic gastrostomy tube

Intervention Type

Device

Intervention Name(s)

J-tube

Intervention Description

jejunal tube

Primary Outcome Measure Information:

Title

Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths and Discontinuations Due to AEs

Description

Time Frame

From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J, plus 30 days.

Title

Number of Participants With Device Complications

Description

Time Frame

12 months

Title

Number of Participants With Potentially Clinically Significant Values for Hematology Parameters

Description

Terms abbreviated in the table include females (f) and males (m).

Time Frame

12 months

Title

Number of Participants With Potentially Clinically Significant Values for Clinical Chemistry Parameters

Description

Terms abbreviated in the table include upper limit of normal (ULN), male (m), and female (f).

Time Frame

12 months

Title

Number of Participants With Potentially Clinically Significant Vital Sign Parameters

Description

Time Frame

12 months

Title

Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Parameters

Description

Time Frame

12 months

Title

Number of Participants With Sleep Attacks at Baseline and Endpoint

Description

Time Frame

Baseline, Endpoint (Month 12 or last post-baseline visit)

Title

Summary of Minnesota Impulsive Disorder Interview (MIDI) Assessment of Intense Impulsive Behavior at Baseline (BL) and Post-baseline (PBL)

Description

Time Frame

Baseline, Post-baseline (up to Month 12)

Title

Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score at Endpoint

Description

Time Frame

Baseline, Endpoint (Month 12 or last post-baseline visit)

Title

Number of Participants With Confirmed Cases of Melanoma

Description

Time Frame

up to Month 12

Title

Number of Participants With Clinically Significant Neurological Examination Findings

Description

Time Frame

up to 12 months

Title

Columbia-Suicide Severity Rating Scale (C-SSRS) Findings

Description

Time Frame

up to 12 months

Title

Number of Participants Taking at Least 1 Concomitant Medication During the Study

Description

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Change From Baseline in Average Daily "Off" Time at Endpoint

Description

Time Frame

Baseline, Endpoint (Month 12 or last post-baseline visit)

Title

Change From Baseline in Average Daily Normalized "On" Time With Troublesome Dyskinesia at Endpoint

Description

Based on the Parkinson's Disease Symptom Diary. "On" time is when PD symptoms are well controlled by the drug. "Off" time is when PD symptoms are not adequately controlled by the drug. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis.

Time Frame

Baseline, Endpoint (Month 12 or last post-baseline visit)

Title

Change From Baseline in Average Daily "On" Time Without Troublesome Dyskinesia at Month 12

Description

Based on the Parkinson's Disease Symptom Diary. "On" time is when PD symptoms are well controlled by the drug. "Off" time is when PD symptoms are not adequately controlled by the drug. "On" time without troublesome dyskinesia (involuntary muscle movement) is defined as "on" time without dyskinesia and "on" time with non-troublesome dyskinesia. The diary is completed every 30 minutes for the full 24 hours of each of 3 days prior to selected clinic visits. It reflects both time awake and time asleep. Daily totals are normalized to a 16-hour scale (i.e. 16 hours of awake time). The normalized totals for the 3 days prior to the visit are averaged for the analysis. Positive change from Baseline for "on" time without troublesome dyskinesia indicates improvement.

Time Frame

Baseline, Endpoint (Month 12 or last post-baseline visit)

Title

Clinical Global Impression - Status (CGI-S) Score at Baseline and Clinical Global Impression - Improvement (CGI-I) Score at Endpoint

Description

Time Frame

Baseline, Endpoint (Month 12 or last post-baseline visit)

Title

Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part I Score at Endpoint

Description

Time Frame

Baseline, Endpoint (Month 12 or last post-baseline visit)

Title

Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score at Endpoint

Description

Time Frame

Baseline, Endpoint (Month 12 or last post-baseline visit)

Title

Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score at Endpoint

Description

Time Frame

Baseline, Endpoint (Month 12 or last post-baseline visit)

Title

Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score at Endpoint

Description

Time Frame

Baseline, Endpoint (Month 12 or last post-baseline visit)

Title

Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Score at Endpoint

Description

Time Frame

Baseline, Endpoint (Month 12 or last post-baseline visit)

Title

Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Summary Index at Endpoint

Description

Time Frame

Baseline, Endpoint (Month 12 or last post-baseline visit)

Title

Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Mobility Domain Score at Endpoint

Description

Time Frame

Baseline, Endpoint (Month 12 or last post-baseline visit)

Title

Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Activities of Daily Living Domain Score at Endpoint

Description

Time Frame

Baseline, Endpoint (Month 12 or last post-baseline visit)

Title

Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Emotional Well-Being Domain Score at Endpoint

Description

Time Frame

Baseline, Endpoint (Month 12 or last post-baseline visit)

Title

Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Stigma Domain Score at Endpoint

Description

Time Frame

Baseline, Endpoint (Month 12 or last post-baseline visit)

Title

Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Social Support Domain Score at Endpoint

Description

Time Frame

Baseline, Endpoint (Month 12 or last post-baseline visit)

Title

Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Cognition Domain Score at Endpoint

Description

Time Frame

Baseline, Endpoint (Month 12 or last post-baseline visit)

Title

Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Communication Domain Score at Endpoint

Description

Time Frame

Baseline, Endpoint (Month 12 or last post-baseline visit)

Title

Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Bodily Discomfort Domain Score at Endpoint

Description

Time Frame

Baseline, Endpoint (Month 12 or last post-baseline visit)

Title

Change From Baseline in EuroQol Quality of Life Scale (EQ-5D) Summary Index at Endpoint

Description

Time Frame

Baseline, Endpoint (Month 12 or last post-baseline visit)

Title

Change From Baseline in EuroQol Quality of Life Scale (EQ-5D) Visual Analogue Scale (VAS) at Endpoint

Description

The EQ-5D VAS records the participant's self-rated health on a scale from 0-100 where 100 is the 'best imaginable health state' and 0 is the 'worst imaginable health state.'

Time Frame

Baseline, Endpoint (Month 12 or last post-baseline visit)

Title

Change From Baseline in Zarit Burden Interview (ZBI) Total Score at Endpoint

Description

Time Frame

Baseline, Endpoint (Month 12 months or last post-baseline visit)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Janet Benesh

Organizational Affiliation

AbbVie

Official's Role

Study Director

Facility Information:

Facility Name

Site Reference ID/Investigator# 45869

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35222

Country

United States

Facility Name

Site Reference ID/Investigator# 45834

City

Fountain Valley

State/Province

California

ZIP/Postal Code

92708

Country

United States

Facility Name

Site Reference ID/Investigator# 45854

City

Los Angeles

State/Province

California

ZIP/Postal Code

90033

Country

United States

Facility Name

Site Reference ID/Investigator# 45856

City

Oceanside

State/Province

California

ZIP/Postal Code

92056

Country

United States

Facility Name

Site Reference ID/Investigator# 45859

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20007

Country

United States

Facility Name

Site Reference ID/Investigator# 45857

City

Bradenton

State/Province

Florida

ZIP/Postal Code

34205

Country

United States

Facility Name

Site Reference ID/Investigator# 45863

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32610

Country

United States

Facility Name

Site Reference ID/Investigator# 45836

City

Port Charlotte

State/Province

Florida

ZIP/Postal Code

33890

Country

United States

Facility Name

Site Reference ID/Investigator# 45874

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Facility Name

Site Reference ID/Investigator# 45868

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40536

Country

United States

Facility Name

Site Reference ID/Investigator# 45862

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21201

Country

United States

Facility Name

Site Reference ID/Investigator# 45861

City

St. Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

Site Reference ID/Investigator# 45873

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

Facility Name

Site Reference ID/Investigator# 45878

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45267

Country

United States

Facility Name

Site Reference ID/Investigator# 45850

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195-0001

Country

United States

Facility Name

Site Reference ID/Investigator# 45887

City

Burlington

State/Province

Vermont

ZIP/Postal Code

05401

Country

United States

Facility Name

Site Reference ID/Investigator# 45828

City

Bochum

ZIP/Postal Code

44791

Country

Germany

Facility Name

Site Reference ID/Investigator# 45829

City

Bremerhaven

ZIP/Postal Code

27574

Country

Germany

Facility Name

Site Reference ID/Investigator# 45825

City

Hanover

ZIP/Postal Code

30625

Country

Germany

Facility Name

Site Reference ID/Investigator# 54402

City

Tuebingen

ZIP/Postal Code

72076

Country

Germany

Facility Name

Site Reference ID/Investigator# 45884

City

Auckland

ZIP/Postal Code

1010

Country

New Zealand

Facility Name

Site Reference ID/Investigator# 45885

City

Hamilton

ZIP/Postal Code

3204

Country

New Zealand

12. IPD Sharing Statement

Links:

URL

http://rxabbvie.com

Description

Related Info

Learn more about this trial

Safety/Efficacy Study of Levodopa-Carbidopa Intestinal Gel in Parkinson's Subjects

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Safety/Efficacy Study of Levodopa-Carbidopa Intestinal Gel in Parkinson's Subjects

Dyskinesias, Parkinson's Disease, Severe Motor Fluctuations

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial