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Open Label Continuation Treatment Study With Levodopa-Carbidopa Intestinal Gel in Advanced Parkinson's Disease

Primary Purpose

Advanced Parkinson's Disease

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Levodopa-Carbidopa Intestinal Gel (LCIG)

CADD-Legacy® 1400 ambulatory infusion pump

Percutaneous Endoscopic Gastrostomy with jejunal extension tube (PEG-J)

About this trial

This is an interventional treatment trial for Advanced Parkinson's Disease focused on measuring levodopa/carbidopa intestinal gel, Severe Motor Fluctuations, Levodopa, Carbidopa, Parkinson's Disease, Dyskinesia

Eligibility Criteria

30 Years - 99 Years (Adult, Older Adult)Does not accept healthy volunteers

Inclusion Criteria:

The subject should have completed participation in Study S187.3.003 or S187.3.004; and, in the opinion of the Principal Investigator, would benefit from long-term treatment with LCIG. - For Canada, subjects will be allowed to participate in the S187.3.005 study with a minimum of 6 months of exposure to LCIG in the S187.3.004 study.
The subject must be able to understand the nature of the study and must provide written informed consent prior to the conduct of any study related procedures. If the subject does not have the capacity to provide informed consent, full informed consent must be obtained from the subject's legally authorized representative. Consenting will be performed according to local regulations.

Exclusion Criteria:

Medical, laboratory, psychiatric, or surgical issues deemed by the investigator to be clinically significant and which could interfere with the subjects participation in the study.

Sites / Locations

University of Alabama at Birmingham /ID# 49941
The Research Center of Southern California /ID# 49928
The Parkinson's & Movement Disorder Institute - Fountain Valley /ID# 49915
Universtiy of Southern California /ID# 49913
Colorado Neurological Institute /ID# 49927
Georgetown University Hospital /ID# 49931
Bradenton Research Center, Inc /ID# 49929
Neurologic Consultants, PA /ID# 49918
University of Florida - Archer /ID# 49935
University of Florida /ID# 49922
Charlotte Neurological Service /ID# 49916
University of South Florida /ID# 49919
Georgia Regents University /ID# 49938
Northwestern University Feinberg School of Medicine /ID# 49944
Rush University Medical Center /ID# 49930
University of Kentucky Chandler Medical Center /ID# 49940
Louisiana State Univ HSC /ID# 49945
Univ Maryland School Medicine /ID# 49934
Johns Hopkins University /ID# 49937
Washington University-School of Medicine /ID# 49933
University of Nebraska Medical Center /ID# 49911
North Shore University Hospital /ID# 49932
The Mount Sinai Hospital /ID# 49942
Columbia Univ Medical Center /ID# 49943
Raleigh Neurology Associates /ID# 49923
Wake Forest Univ HS /ID# 49939
University of Cincinnati /ID# 49914
Cleveland Clinic Main Campus /ID# 76173
University of Vermont Medical Center /ID# 49912
King County Public Hospital /ID# 49917
Froedtert Memorial Lutheran Hospital /ID# 49924
Westmead Hospital /ID# 50081
Royal Adelaide Hospital /ID# 50083
Austin Hospital /ID# 50082
University of Alberta /ID# 78476
Toronto Western Hospital /ID# 75913
CHUM - Notre-Dame Hospital /ID# 74513
Fakultni Nemocnice u Svate Anny /ID# 50085
Fakultni nemocnice Hradec Kralove /ID# 50088
Pardubicka krajska nemocnice, a.s.
Vseobecna fakultni nemocnice v Praze /ID# 50086
Fakultni Nemocnice v Motole /ID# 50084
Tel Aviv Sourasky Medical Center /ID# 50089
Waikato Hospital /ID# 50091
Auckland City Hospital /ID# 50093
New Zealand Brain Research Institute/ID# 50090
Wellington Hospital /ID# 50092
Miejskie Centrum Medyczne im. dr. Karola Jonschera w Lodzi /ID# 50096
NZOZ Centrum Medyczne HCP /ID# 50094
Hospitais da Universidade de Coimbra /ID# 50098
Hospital de Santa Maria /ID# 50099
Centro Hospitalar Universitario de Sao Joao, EPE /ID# 50101
Scientific Research Medical Complex Your Health /ID# 50104
Institution of the Russian Academy of Medical Sciences Scientific Centre of Neurology /ID# 50102
Military Medical Academy n.a. Kirov /ID# 50103
I.P. Pavlov First St. Petersburg State Medical University /ID# 50107
City Clinical Hospital #40 /ID# 50106
King Chulalongkorn Mem Hosp /ID# 50108
Siriraj Hospital /ID# 50109
The Walton Centre NHS Foundation /ID# 50003
National Hospital for Neurology & Neurosurgery

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Levodopa-Carbidopa Intestinal Gel

Arm Description

Initial dosing is based on the dosing regimen that the participant received during the previous LCIG study. Dosing is individually optimized and can be adjusted at any time during the study as clinically indicated. The total dose/day of LCIG is composed of 3 individually adjusted doses. The morning dose is administered as a bolus infusion, usually 5 to 10 mL (100 to 200 mg levodopa). The maintenance dose is adjustable in steps of 2 mg/hour (0.1 mL/hour), within a range of 1 to 10 mL/hour (20 to 200 mg levodopa/hour) and is usually 2 to 6 mL/hour (40 to 120 mg levodopa/hour). Participants will be allowed to self-administer extra doses of LCIG to address immediate medical needs, normally 0.5 to 2.0 mL. Participants will receive LCIG until it is commercially available.

Outcomes

Primary Outcome Measures

Number of Participants With Treatment-emergent Adverse Events

Treatment-emergent adverse events (TEAEs) are defined as adverse events (AEs) which started on or after the date of the first LCIG Infusion in this study and within 30 days of the date of the last PEG-J exposure. At least possibly drug-related is defined as TEAEs assessed as having a "Possible" or "Probable" or missing relationship to study drug. Serious AEs included any untoward medical occurrence that: Resulted in death Was life-threatening Required inpatient hospitalization or prolongation of an existing hospitalization Resulted in persistent or significant disability/incapacity was a congenital anomaly/birth defect The severity of all AEs was characterized as mild, moderate or severe according to the following definitions: Mild: usually transient and do not interfere with daily activities. Moderate: low level of inconvenience or concern to the subject, may interfere with daily activities. Severe: events interrupt the subject's usual daily activity.

Secondary Outcome Measures

Number of Participants With Device Complications

Device complications include complications with the pump, intestinal tube, PEG-J or stoma.

Number of Participants With Sleep Attacks

Participants were asked whether they 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. If yes, participants were asked if they suffered any "bad" outcome or problem from the falling asleep event.

Number of Participants With Intense Impulsive Behavior

To monitor for the development of intense impulsive behavior the Minnesota Impulsive Disorder Interview (MIDI) was administered. The MIDI is a semi-structured clinical interview assessing pathological gambling, trichotillomania, kleptomania, pyromania, intermittent explosive disorder, compulsive buying, and compulsive sexual behavior.

Number of Participants Who Developed Melanoma

A comprehensive assessment for the presence of melanoma was performed at least once a year by a dermatologist.

Number of Participants With Treatment-emergent Adverse Events of Special Interest (TE AESI)

Adverse events of special interest (AESIs) were identified using standardized Medical Dictionary for Regulatory Activities (MedDRA) queries (SMQ) or company MedDRA queries (CMQs). The AESI in the following categories were identified on the basis of review of the clinical program and postmarketing observations where the treatment system is commercially available. Procedure and device associated events Polyneuropathy, included preferred terms in either the peripheral neuropathy or GuillainBarre syndrome standardized MedDRA query (narrow search), such as polyneuropathy, decreased vibratory sense, peripheral neuropathy, peripheral sensory neuropathy, neuralgia, demyelinating polyneuropathy, and sensory disturbance Weight loss Cardiovascular fatalities Respiratory tract aspiration including aspiration pneumonia/pneumonitis.

Number of Participants With Any Suicidal Ideation or Behavior

The Columbia-Suicide Severity Rating Scale (C-SSRS) was implemented with Protocol Amendment 3 (20 March 2012) in order to assess suicidal behavior and ideation. Suicidal ideation includes the wish to be dead, nonspecific active suicidal thoughts, active ideation without intent to act, active ideation with some intent to act, and active ideation with specific plan or intent. Suicidal behavior includes actual attempts, interrupted attempts, aborted attempts, completed suicide, and preparatory acts or behaviors. The number of participants with affirmative responses on the C-SSRS at any time during the treatment period is reported.

Number of Participants With Potentially Clinically Significant Vital Sign Values

A vital sign value was considered potentially clinically significant if it satisfied the pre-specified criteria presented in the table and was also more extreme than the participant's corresponding Baseline value.

Number of Participants With Potentially Clinically Significant Hematology Laboratory Values

A laboratory value was considered potentially clinically significant if it satisfied the pre-specified criteria presented in the table and was also more extreme than the participant's corresponding Baseline value.

Number of Participants With Potentially Clinically Significant Chemistry Laboratory Values

Number of Participants With Vitamin Levels Outside of the Normal Range

Special tests for vitamin deficiencies (folic acid, vitamin B6, vitamin B12, methylmalonic acid [MMA], and homocysteine) were implemented with Protocol Amendment 2 (27 July 2011). The number of participants with vitamin levels outside of the normal range at any time post-baseline is reported for each vitamin tested.

Number of Participants Receiving Concomitant Anti-Parkinson's Disease Medications by Treatment Year

Participants could use oral levodopa-carbidopa for scheduled or supplemental bedtime/overnight doses after the pump was disconnected for the night, or as rescue medication in case of acute deterioration caused by failure of the LCIG system such as tubes and/or the pump or the onset of an acute illness. The initiation of additional concomitant PD medication was allowed at the discretion of the Investigator if medically indicated.

Change in Average Daily "Off" Time Based on the Parkinson's Disease Symptom Diary at End of Treatment

The PD symptom diary asks participants (or their caregivers) to indicate their status upon waking and every 30 minutes during their normal waking time according to the following categories: asleep, "off", "on" without dyskinesia, "on" with non-troublesome dyskinesia, or "on" with troublesome dyskinesia. "Off" time was defined as time when medication had worn off and was no longer providing benefit with regard to mobility, slowness, and stiffness. PD diary times were normalized to a 16-hour waking day and averaged for the 3 days prior to each study visit. A negative change for "off" time indicates improvement. The PD diary assessment was implemented with Protocol amendment 4 (December 2013) for participants at United States (US) sites only.

Change in Average Daily "On" Time Without Troublesome Dyskinesia Based on the Parkinson's Disease Symptom Diary at End of Treatment

The PD diary asks participants (or their caregivers) to indicate their status upon waking and every 30 minutes during their normal waking time according to the following categories: asleep, "off", "on" without dyskinesia, "on" with non-troublesome dyskinesia, or "on" with troublesome dyskinesia. "On" time is when medication is providing benefit with regard to mobility, slowness and stiffness. Dyskinesia is involuntary twisting, turning movements which are an effect of medication and occur during "on" time. Non-troublesome dyskinesia does not interfere with function or cause meaningful discomfort. "On" time without troublesome dyskinesia is the sum of "on" time without dyskinesia and "on" time with non-troublesome dyskinesia. PD diary times were normalized to a 16-hour waking day and averaged for the 3 days prior to each study visit. A positive change indicates improvement. The PD diary was implemented with Protocol amendment 4 (December 2013) for participants at US sites only.

Change in Average Daily "On" Time With Troublesome Dyskinesia Based on the Parkinson's Disease Symptom Diary at End of Treatment

The PD diary asks participants (or their caregivers) to indicate their status upon waking and every 30 minutes during their normal waking time according to the following categories: asleep, "off", "on" without dyskinesia, "on" with non-troublesome dyskinesia, or "on" with troublesome dyskinesia. "On" time is when medication is providing benefit with regard to mobility, slowness and stiffness. Dyskinesia is involuntary twisting, turning movements which are an effect of medication and occur during "on" time. Troublesome dyskinesia interferes with function or causes meaningful discomfort. PD diary times were normalized to a 16-hour waking day and averaged for the 3 days prior to each study visit. A positive change indicates improvement. The PD diary was implemented with Protocol amendment 4 (December 2013) for participants at US sites only.

Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part I Score at End of Treatment

The UPDRS is an Investigator-used rating tool to follow the longitudinal course of PD. It is made up of the following sections: I) Mentation, Behavior, and Mood; II) Activities of Daily Living; III) Motor Examinations; IV) Complications of Therapy sections (including dyskinesias). 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. A negative change from Baseline indicates improvement. The UPDRS was implemented with Protocol amendment 4 (December 2013) for participants at US sites only.

Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score at End of Treatment

The UPDRS is an Investigator-used rating tool to follow the longitudinal course of PD. It is made up of the following sections: I) Mentation, Behavior, and Mood; II) Activities of Daily Living; III) Motor Examinations; IV) Complications of Therapy sections (including dyskinesias). 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. A negative change from Baseline indicates improvement. The UPDRS was implemented with Protocol amendment 4 (December 2013) for participants at US sites only.

Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score at End of Treatment

The UPDRS is an Investigator-used rating tool to follow the longitudinal course of PD. It is made up of the following sections: I) Mentation, Behavior, and Mood; II) Activities of Daily Living; III) Motor Examinations; IV) Complications of Therapy sections (including dyskinesias). UPDRS Part III consists of 14 questions. Questions 20 - 26 are multi-part questions in that they are evaluated separately for multiple body parts. Counting each of these assessments leads to a total of 27 answers for Part III. The UPDRS 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. A negative change from Baseline indicates improvement. The UPDRS was implemented with Protocol amendment 4 (December 2013) for participants at US sites only.

Change in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score at End of Treatment

The UPDRS is an Investigator-used rating tool to follow the longitudinal course of PD. It is made up of the following sections: I) Mentation, Behavior, and Mood; II) Activities of Daily Living; III) Motor Examinations; IV) Complications of Therapy sections (including dyskinesias). The UPDRS 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 ranges from 0 - 176 with 176 representing the worst (total) disability, and 0 no disability. A negative change from Baseline indicates improvement. The UPDRS was implemented with Protocol amendment 4 (December 2013) for participants at US sites only.

Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Score at End of Treatment

The UPDRS is an Investigator-used rating tool to follow the longitudinal course of PD. It is made up of the following sections: I) Mentation, Behavior, and Mood; II) Activities of Daily Living; III) Motor Examinations; IV) Complications of Therapy sections (including Dyskinesias). The UPDRS Part IV Score is the sum of all answers to the 11 questions that comprise Part IV, 4 of which are measured on a 5-point scale (0 - 4) and 7 which are measured on a 2-point scale (0 - 1). The Part IV score ranges from 0 - 23 with higher scores associated with more disability. A negative change from Baseline indicates improvement. The UPDRS was implemented with Protocol amendment 4 (December 2013) for participants at US sites only.

Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Dyskinesia Score at End of Treatment

The UPDRS is an Investigator-used rating tool to follow the longitudinal course of PD. It is made up of the following sections: I) Mentation, Behavior, and Mood; II) Activities of Daily Living; III) Motor Examinations; IV) Complications of Therapy sections (including Dyskinesias); and The UPDRS Part IV dyskinesia Score is the sum of Questions 32 (What proportion of the waking day are dyskinesias present?), 33 (How disabling are the dyskinesias? ), and 34 (How painful are the dyskinesias?) on UPDRS Part IV, each of which are measured on a 5-point scale (0-4). The Part IV dyskinesia score ranges from 0 - 12 and higher scores are associated with more disability. A negative change from Baseline indicates improvement. The UPDRS was implemented with Protocol amendment 4 (December 2013) for participants at US sites only.

Change in Parkinson's Disease Questionnaire (PDQ-39) Scores at End of Treatment

The PDQ-39 is a self-administered questionnaire that comprises 39 items addressing the following eight domains of health that patients consider to be adversely affected by the disease: Mobility (e.g., fear of falling when walking) - 10 questions Activities of daily living (e.g., difficulty cutting food) - 6 questions Emotional well-being (e.g., feelings of isolation) - 6 questions Stigma (e.g., social embarrassment) - 4 questions Social support - 3 questions Cognition - 4 questions Communication - 3 questions Bodily discomfort - 3 questions Each question is answered on a 5-point scale from 0 (Never) to 4 (Always / Cannot Do At All). Scores are calculated by summing the answers to the questions in the domain and converting to a scale from 0 to 100. Higher scores are associated with the more severe symptoms of the disease such as tremor and stiffness. The PDQ-39 summary index (range 0-100) includes responses to all 39 items. A negative change indicates improvement.

Full Information

NCT ID

NCT00660673

First Posted

April 15, 2008

Last Updated

November 15, 2022

Sponsor

AbbVie

Collaborators

IQVIA, formerly Quintiles

1. Study Identification

Unique Protocol Identification Number

NCT00660673

Brief Title

Open Label Continuation Treatment Study With Levodopa-Carbidopa Intestinal Gel in Advanced Parkinson's Disease

Official Title

Open-Label Continuation Treatment Study With Levodopa - Carbidopa Intestinal Gel In Subjects With Advanced Parkinson's Disease And Severe Motor-Fluctuations Who Have Exhibited A Persistent And Positive Effect To Treatment In Previous Studies

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Completed

Study Start Date

November 13, 2009 (Actual)

Primary Completion Date

November 30, 2021 (Actual)

Study Completion Date

November 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AbbVie

Collaborators

IQVIA, formerly Quintiles

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

The primary objective of this study is to provide continued access to levodopa-carbidopa intestinal gel (LCIG), to participants who have already participated in an open-label efficacy and safety study with the same treatment (Study S187.3.003 [NCT00360568] or Study S187.3.004 [NCT00335153]).

6. Conditions and Keywords

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

Advanced Parkinson's Disease

Keywords

levodopa/carbidopa intestinal gel, Severe Motor Fluctuations, Levodopa, Carbidopa, Parkinson's Disease, Dyskinesia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

262 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Levodopa-Carbidopa Intestinal Gel

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Levodopa-Carbidopa Intestinal Gel (LCIG)

Other Intervention Name(s)

Carbidopa-Levodopa Enteral Suspension (CLES), Duopa®, Duodopa®

Intervention Description

LCIG for upper-intestinal infusion is a suspension of levodopa (20 mg/mL) and carbidopa (5 mg/mL) in an aqueous gel that is dispensed in a medication cassette reservoir containing 100 mL of LCIG.

Intervention Type

Device

Intervention Name(s)

CADD-Legacy® 1400 ambulatory infusion pump

Intervention Description

Portable infusion pump (CADD-Legacy Pump Model 1400) connected to the LCIG medication cassette reservoir.

Intervention Type

Device

Intervention Name(s)

Percutaneous Endoscopic Gastrostomy with jejunal extension tube (PEG-J)

Intervention Description

All participants previously had a PEG-J placed in one of the prior LCIG studies.

Primary Outcome Measure Information:

Title

Number of Participants With Treatment-emergent Adverse Events

Description

Time Frame

From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, with a maximum of 4217 days (11.5 years).

Secondary Outcome Measure Information:

Title

Number of Participants With Device Complications

Description

Device complications include complications with the pump, intestinal tube, PEG-J or stoma.

Time Frame

From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days.

Title

Number of Participants With Sleep Attacks

Description

Time Frame

Baseline (final assessment period of the previous open-label LCIG study) and every 6 months until final visit; median duration of treatment was 1178 days.

Title

Number of Participants With Intense Impulsive Behavior

Description

Time Frame

Baseline (final assessment of the previous open-label LCIG study) and every 6 months until final visit; median duration of treatment was 1178 days.

Title

Number of Participants Who Developed Melanoma

Description

A comprehensive assessment for the presence of melanoma was performed at least once a year by a dermatologist.

Time Frame

Once per year during the study; median duration of treatment was 1178 days.

Title

Number of Participants With Treatment-emergent Adverse Events of Special Interest (TE AESI)

Description

Time Frame

From first dose of LCIG in this study up to 30 days after the date of last PEG-J exposure; median duration of treatment was 1178 days, with a maximum of 4217 days (11.5 years).

Title

Number of Participants With Any Suicidal Ideation or Behavior

Description

Time Frame

Every 6 months (beginning with implementation of Protocol Amendment 3) until final visit; median duration of treatment was 1178 days.

Title

Number of Participants With Potentially Clinically Significant Vital Sign Values

Description

Time Frame

Baseline and every 6 months until final visit; median duration of treatment was 1178 days.

Title

Number of Participants With Potentially Clinically Significant Hematology Laboratory Values

Description

Time Frame

Baseline and every 6 months until final visit; median duration of treatment was 1178 days.

Title

Number of Participants With Potentially Clinically Significant Chemistry Laboratory Values

Description

Time Frame

Baseline and every 6 months until final visit; median duration of treatment was 1178 days.

Title

Number of Participants With Vitamin Levels Outside of the Normal Range

Description

Time Frame

Every 6 months (beginning with implementation of Protocol Amendment 2) until final visit; median duration of treatment was 1178 days.

Title

Number of Participants Receiving Concomitant Anti-Parkinson's Disease Medications by Treatment Year

Description

Time Frame

Year 1, Year 2, Year 3, Year 4, Year 5, Year 6, Year 7, Year 8, Year 9, Year 10, > Year 10 (maximum time on treatment was approximately 11.5 years).

Title

Change in Average Daily "Off" Time Based on the Parkinson's Disease Symptom Diary at End of Treatment

Description

Time Frame

Prior to initial LCIG infusion (in the previous study, before the first LCIG infusion), Baseline (final assessment of the previous open-label LCIG study), and end of treatment; median duration of treatment was 1178 days.

Title

Change in Average Daily "On" Time Without Troublesome Dyskinesia Based on the Parkinson's Disease Symptom Diary at End of Treatment

Description

Time Frame

Title

Change in Average Daily "On" Time With Troublesome Dyskinesia Based on the Parkinson's Disease Symptom Diary at End of Treatment

Description

The PD diary asks participants (or their caregivers) to indicate their status upon waking and every 30 minutes during their normal waking time according to the following categories: asleep, "off", "on" without dyskinesia, "on" with non-troublesome dyskinesia, or "on" with troublesome dyskinesia. "On" time is when medication is providing benefit with regard to mobility, slowness and stiffness. Dyskinesia is involuntary twisting, turning movements which are an effect of medication and occur during "on" time. Troublesome dyskinesia interferes with function or causes meaningful discomfort. PD diary times were normalized to a 16-hour waking day and averaged for the 3 days prior to each study visit. A positive change indicates improvement. The PD diary was implemented with Protocol amendment 4 (December 2013) for participants at US sites only.

Time Frame

Title

Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part I Score at End of Treatment

Description

Time Frame

Title

Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score at End of Treatment

Description

The UPDRS is an Investigator-used rating tool to follow the longitudinal course of PD. It is made up of the following sections: I) Mentation, Behavior, and Mood; II) Activities of Daily Living; III) Motor Examinations; IV) Complications of Therapy sections (including dyskinesias). 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. A negative change from Baseline indicates improvement. The UPDRS was implemented with Protocol amendment 4 (December 2013) for participants at US sites only.

Time Frame

Title

Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score at End of Treatment

Description

The UPDRS is an Investigator-used rating tool to follow the longitudinal course of PD. It is made up of the following sections: I) Mentation, Behavior, and Mood; II) Activities of Daily Living; III) Motor Examinations; IV) Complications of Therapy sections (including dyskinesias). UPDRS Part III consists of 14 questions. Questions 20 - 26 are multi-part questions in that they are evaluated separately for multiple body parts. Counting each of these assessments leads to a total of 27 answers for Part III. The UPDRS 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. A negative change from Baseline indicates improvement. The UPDRS was implemented with Protocol amendment 4 (December 2013) for participants at US sites only.

Time Frame

Title

Change in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score at End of Treatment

Description

The UPDRS is an Investigator-used rating tool to follow the longitudinal course of PD. It is made up of the following sections: I) Mentation, Behavior, and Mood; II) Activities of Daily Living; III) Motor Examinations; IV) Complications of Therapy sections (including dyskinesias). The UPDRS 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 ranges from 0 - 176 with 176 representing the worst (total) disability, and 0 no disability. A negative change from Baseline indicates improvement. The UPDRS was implemented with Protocol amendment 4 (December 2013) for participants at US sites only.

Time Frame

Title

Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Score at End of Treatment

Description

The UPDRS is an Investigator-used rating tool to follow the longitudinal course of PD. It is made up of the following sections: I) Mentation, Behavior, and Mood; II) Activities of Daily Living; III) Motor Examinations; IV) Complications of Therapy sections (including Dyskinesias). The UPDRS Part IV Score is the sum of all answers to the 11 questions that comprise Part IV, 4 of which are measured on a 5-point scale (0 - 4) and 7 which are measured on a 2-point scale (0 - 1). The Part IV score ranges from 0 - 23 with higher scores associated with more disability. A negative change from Baseline indicates improvement. The UPDRS was implemented with Protocol amendment 4 (December 2013) for participants at US sites only.

Time Frame

Title

Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Dyskinesia Score at End of Treatment

Description

The UPDRS is an Investigator-used rating tool to follow the longitudinal course of PD. It is made up of the following sections: I) Mentation, Behavior, and Mood; II) Activities of Daily Living; III) Motor Examinations; IV) Complications of Therapy sections (including Dyskinesias); and The UPDRS Part IV dyskinesia Score is the sum of Questions 32 (What proportion of the waking day are dyskinesias present?), 33 (How disabling are the dyskinesias? ), and 34 (How painful are the dyskinesias?) on UPDRS Part IV, each of which are measured on a 5-point scale (0-4). The Part IV dyskinesia score ranges from 0 - 12 and higher scores are associated with more disability. A negative change from Baseline indicates improvement. The UPDRS was implemented with Protocol amendment 4 (December 2013) for participants at US sites only.

Time Frame

Title

Change in Parkinson's Disease Questionnaire (PDQ-39) Scores at End of Treatment

Description

Time Frame

10. Eligibility

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: The participant should have completed participation in Study S187.3.003 or S187.3.004; and, in the opinion of the Principal Investigator, would benefit from long-term treatment with LCIG. For Canada, participants will be allowed to participate in the S187.3.005 study with a minimum of 6 months of exposure to LCIG in the S187.3.004 study. The participant must be able to understand the nature of the study and must provide written informed consent prior to the conduct of any study related procedures. If the participant does not have the capacity to provide informed consent, full informed consent must be obtained from the participant's legally authorized representative. Consenting will be performed according to local regulations. Exclusion Criteria: Medical, laboratory, psychiatric, or surgical issues deemed by the investigator to be clinically significant and which could interfere with the participant's participation in the study.

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 /ID# 49941

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35294

Country

United States

Facility Name

The Research Center of Southern California /ID# 49928

City

Encinitas

State/Province

California

ZIP/Postal Code

92024

Country

United States

Facility Name

The Parkinson's & Movement Disorder Institute - Fountain Valley /ID# 49915

City

Fountain Valley

State/Province

California

ZIP/Postal Code

92708

Country

United States

Facility Name

Universtiy of Southern California /ID# 49913

City

Los Angeles

State/Province

California

ZIP/Postal Code

90033

Country

United States

Facility Name

Colorado Neurological Institute /ID# 49927

City

Englewood

State/Province

Colorado

ZIP/Postal Code

80113

Country

United States

Facility Name

Georgetown University Hospital /ID# 49931

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20007

Country

United States

Facility Name

Bradenton Research Center, Inc /ID# 49929

City

Bradenton

State/Province

Florida

ZIP/Postal Code

34205

Country

United States

Facility Name

Neurologic Consultants, PA /ID# 49918

City

Fort Lauderdale

State/Province

Florida

ZIP/Postal Code

33308

Country

United States

Facility Name

University of Florida - Archer /ID# 49935

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32610

Country

United States

Facility Name

University of Florida /ID# 49922

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32209

Country

United States

Facility Name

Charlotte Neurological Service /ID# 49916

City

Port Charlotte

State/Province

Florida

ZIP/Postal Code

33980

Country

United States

Facility Name

University of South Florida /ID# 49919

City

Tampa

State/Province

Florida

ZIP/Postal Code

33612

Country

United States

Facility Name

Georgia Regents University /ID# 49938

City

Augusta

State/Province

Georgia

ZIP/Postal Code

30912

Country

United States

Facility Name

Northwestern University Feinberg School of Medicine /ID# 49944

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611-2927

Country

United States

Facility Name

Rush University Medical Center /ID# 49930

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60612

Country

United States

Facility Name

University of Kentucky Chandler Medical Center /ID# 49940

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40536

Country

United States

Facility Name

Louisiana State Univ HSC /ID# 49945

City

Shreveport

State/Province

Louisiana

ZIP/Postal Code

71130

Country

United States

Facility Name

Univ Maryland School Medicine /ID# 49934

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21201

Country

United States

Facility Name

Johns Hopkins University /ID# 49937

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21287

Country

United States

Facility Name

Washington University-School of Medicine /ID# 49933

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

University of Nebraska Medical Center /ID# 49911

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68198

Country

United States

Facility Name

North Shore University Hospital /ID# 49932

City

Manhasset

State/Province

New York

ZIP/Postal Code

11030

Country

United States

Facility Name

The Mount Sinai Hospital /ID# 49942

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

Facility Name

Columbia Univ Medical Center /ID# 49943

City

New York

State/Province

New York

ZIP/Postal Code

10032-3725

Country

United States

Facility Name

Raleigh Neurology Associates /ID# 49923

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27607

Country

United States

Facility Name

Wake Forest Univ HS /ID# 49939

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27157

Country

United States

Facility Name

University of Cincinnati /ID# 49914

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45267-0585

Country

United States

Facility Name

Cleveland Clinic Main Campus /ID# 76173

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

Facility Name

University of Vermont Medical Center /ID# 49912

City

Burlington

State/Province

Vermont

ZIP/Postal Code

05401-1473

Country

United States

Facility Name

King County Public Hospital /ID# 49917

City

Kirkland

State/Province

Washington

ZIP/Postal Code

98034

Country

United States

Facility Name

Froedtert Memorial Lutheran Hospital /ID# 49924

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53226

Country

United States

Facility Name

Westmead Hospital /ID# 50081

City

Westmead

State/Province

New South Wales

ZIP/Postal Code

2145

Country

Australia

Facility Name

Royal Adelaide Hospital /ID# 50083

City

Adelaide

State/Province

South Australia

ZIP/Postal Code

5000

Country

Australia

Facility Name

Austin Hospital /ID# 50082

City

Heidelberg

State/Province

Victoria

ZIP/Postal Code

3084

Country

Australia

Facility Name

University of Alberta /ID# 78476

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 2B7

Country

Canada

Facility Name

Toronto Western Hospital /ID# 75913

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5T 2S8

Country

Canada

Facility Name

CHUM - Notre-Dame Hospital /ID# 74513

City

Montréal

State/Province

Quebec

ZIP/Postal Code

H2X 0A9

Country

Canada

Facility Name

Fakultni Nemocnice u Svate Anny /ID# 50085

City

Brno

ZIP/Postal Code

656 91

Country

Czechia

Facility Name

Fakultni nemocnice Hradec Kralove /ID# 50088

City

Hradec Králové

ZIP/Postal Code

500 05

Country

Czechia

Facility Name

Pardubicka krajska nemocnice, a.s.

City

Pardubice

ZIP/Postal Code

532 03

Country

Czechia

Facility Name

Vseobecna fakultni nemocnice v Praze /ID# 50086

City

Praha

ZIP/Postal Code

128 21

Country

Czechia

Facility Name

Fakultni Nemocnice v Motole /ID# 50084

City

Praha

ZIP/Postal Code

150 06

Country

Czechia

Facility Name

Tel Aviv Sourasky Medical Center /ID# 50089

City

Tel-Aviv

ZIP/Postal Code

64239

Country

Israel

Facility Name

Waikato Hospital /ID# 50091

City

Hamilton

State/Province

Waikato

ZIP/Postal Code

3240

Country

New Zealand

Facility Name

Auckland City Hospital /ID# 50093

City

Auckland

ZIP/Postal Code

1023

Country

New Zealand

Facility Name

New Zealand Brain Research Institute/ID# 50090

City

Christchurch

ZIP/Postal Code

8011

Country

New Zealand

Facility Name

Wellington Hospital /ID# 50092

City

Wellington

ZIP/Postal Code

6021

Country

New Zealand

Facility Name

Miejskie Centrum Medyczne im. dr. Karola Jonschera w Lodzi /ID# 50096

City

Łódź

State/Province

Lodzkie

ZIP/Postal Code

93-113

Country

Poland

Facility Name

NZOZ Centrum Medyczne HCP /ID# 50094

City

Poznań

State/Province

Wielkopolskie

ZIP/Postal Code

61-485

Country

Poland

Facility Name

Hospitais da Universidade de Coimbra /ID# 50098

City

Coimbra

ZIP/Postal Code

3000-075

Country

Portugal

Facility Name

Hospital de Santa Maria /ID# 50099

City

Lisboa

ZIP/Postal Code

1649-035

Country

Portugal

Facility Name

Centro Hospitalar Universitario de Sao Joao, EPE /ID# 50101

City

Porto

ZIP/Postal Code

4200-319

Country

Portugal

Facility Name

Scientific Research Medical Complex Your Health /ID# 50104

City

Kazan

ZIP/Postal Code

420097

Country

Russian Federation

Facility Name

Institution of the Russian Academy of Medical Sciences Scientific Centre of Neurology /ID# 50102

City

Moscow

ZIP/Postal Code

125367

Country

Russian Federation

Facility Name

Military Medical Academy n.a. Kirov /ID# 50103

City

Saint Petersburg

ZIP/Postal Code

194044

Country

Russian Federation

Facility Name

I.P. Pavlov First St. Petersburg State Medical University /ID# 50107

City

Saint Petersburg

ZIP/Postal Code

197022

Country

Russian Federation

Facility Name

City Clinical Hospital #40 /ID# 50106

City

Saint Petersburg

ZIP/Postal Code

197706

Country

Russian Federation

Facility Name

King Chulalongkorn Mem Hosp /ID# 50108

City

Bangkok

ZIP/Postal Code

10330

Country

Thailand

Facility Name

Siriraj Hospital /ID# 50109

City

Bangkok

ZIP/Postal Code

10700

Country

Thailand

Facility Name

The Walton Centre NHS Foundation /ID# 50003

City

Liverpool

ZIP/Postal Code

L9 7LJ

Country

United Kingdom

Facility Name

National Hospital for Neurology & Neurosurgery

City

London

ZIP/Postal Code

WC1N 3BG

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://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html

Citations:

PubMed Identifier

29570853

Citation

Fernandez HH, Boyd JT, Fung VSC, Lew MF, Rodriguez RL, Slevin JT, Standaert DG, Zadikoff C, Vanagunas AD, Chatamra K, Eaton S, Facheris MF, Hall C, Robieson WZ, Benesh J, Espay AJ. Long-term safety and efficacy of levodopa-carbidopa intestinal gel in advanced Parkinson's disease. Mov Disord. 2018 Jul;33(6):928-936. doi: 10.1002/mds.27338. Epub 2018 Mar 23.

Results Reference

result

Links:

URL

http://rxabbvie.com

Description

Related Info

Learn more about this trial

Open Label Continuation Treatment Study With Levodopa-Carbidopa Intestinal Gel in Advanced Parkinson's Disease

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