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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00360568




Registration number
NCT00360568
Ethics application status
Date submitted
3/08/2006
Date registered
4/08/2006
Date last updated
16/01/2015

Titles & IDs
Public title
Safety/Efficacy Study of Levodopa-Carbidopa Intestinal Gel in Parkinson's Subjects
Scientific title
Open-Label, 12-Month Safety and Efficacy Study of Levodopa - Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Disease Subjects
Secondary ID [1] 0 0
2006-000578-53
Secondary ID [2] 0 0
S187.3.003
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dyskinesias 0 0
Parkinson's Disease 0 0
Severe Motor Fluctuations 0 0
Condition category
Condition code
Neurological 0 0 0 0
Parkinson's disease
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Levodopa-carbidopa intestinal gel
Treatment: Devices - PEG tube
Treatment: Devices - J-tube

Experimental: Levodopa-Carbidopa Intestinal Gel (LCIG) - 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.


Treatment: Drugs: Levodopa-carbidopa intestinal gel
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).

Treatment: Devices: PEG tube
percutaneous endoscopic gastrostomy tube

Treatment: Devices: J-tube
jejunal tube
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths and Discontinuations Due to AEs
Timepoint [1] 0 0
From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J, plus 30 days.
Primary outcome [2] 0 0
Number of Participants With Device Complications
Timepoint [2] 0 0
12 months
Primary outcome [3] 0 0
Number of Participants With Potentially Clinically Significant Values for Hematology Parameters
Timepoint [3] 0 0
12 months
Primary outcome [4] 0 0
Number of Participants With Potentially Clinically Significant Values for Clinical Chemistry Parameters
Timepoint [4] 0 0
12 months
Primary outcome [5] 0 0
Number of Participants With Potentially Clinically Significant Vital Sign Parameters
Timepoint [5] 0 0
12 months
Primary outcome [6] 0 0
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Parameters
Timepoint [6] 0 0
12 months
Primary outcome [7] 0 0
Number of Participants With Sleep Attacks at Baseline and Endpoint
Timepoint [7] 0 0
Baseline, Endpoint (Month 12 or last post-baseline visit)
Primary outcome [8] 0 0
Summary of Minnesota Impulsive Disorder Interview (MIDI) Assessment of Intense Impulsive Behavior at Baseline (BL) and Post-baseline (PBL)
Timepoint [8] 0 0
Baseline, Post-baseline (up to Month 12)
Primary outcome [9] 0 0
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score at Endpoint
Timepoint [9] 0 0
Baseline, Endpoint (Month 12 or last post-baseline visit)
Primary outcome [10] 0 0
Number of Participants With Confirmed Cases of Melanoma
Timepoint [10] 0 0
up to Month 12
Primary outcome [11] 0 0
Number of Participants With Clinically Significant Neurological Examination Findings
Timepoint [11] 0 0
up to 12 months
Primary outcome [12] 0 0
Columbia-Suicide Severity Rating Scale (C-SSRS) Findings
Timepoint [12] 0 0
up to 12 months
Primary outcome [13] 0 0
Number of Participants Taking at Least 1 Concomitant Medication During the Study
Timepoint [13] 0 0
12 months
Secondary outcome [1] 0 0
Change From Baseline in Average Daily "Off" Time at Endpoint
Timepoint [1] 0 0
Baseline, Endpoint (Month 12 or last post-baseline visit)
Secondary outcome [2] 0 0
Change From Baseline in Average Daily Normalized "On" Time With Troublesome Dyskinesia at Endpoint
Timepoint [2] 0 0
Baseline, Endpoint (Month 12 or last post-baseline visit)
Secondary outcome [3] 0 0
Change From Baseline in Average Daily "On" Time Without Troublesome Dyskinesia at Month 12
Timepoint [3] 0 0
Baseline, Endpoint (Month 12 or last post-baseline visit)
Secondary outcome [4] 0 0
Clinical Global Impression - Status (CGI-S) Score at Baseline and Clinical Global Impression - Improvement (CGI-I) Score at Endpoint
Timepoint [4] 0 0
Baseline, Endpoint (Month 12 or last post-baseline visit)
Secondary outcome [5] 0 0
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part I Score at Endpoint
Timepoint [5] 0 0
Baseline, Endpoint (Month 12 or last post-baseline visit)
Secondary outcome [6] 0 0
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score at Endpoint
Timepoint [6] 0 0
Baseline, Endpoint (Month 12 or last post-baseline visit)
Secondary outcome [7] 0 0
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score at Endpoint
Timepoint [7] 0 0
Baseline, Endpoint (Month 12 or last post-baseline visit)
Secondary outcome [8] 0 0
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score at Endpoint
Timepoint [8] 0 0
Baseline, Endpoint (Month 12 or last post-baseline visit)
Secondary outcome [9] 0 0
Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Score at Endpoint
Timepoint [9] 0 0
Baseline, Endpoint (Month 12 or last post-baseline visit)
Secondary outcome [10] 0 0
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Summary Index at Endpoint
Timepoint [10] 0 0
Baseline, Endpoint (Month 12 or last post-baseline visit)
Secondary outcome [11] 0 0
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Mobility Domain Score at Endpoint
Timepoint [11] 0 0
Baseline, Endpoint (Month 12 or last post-baseline visit)
Secondary outcome [12] 0 0
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Activities of Daily Living Domain Score at Endpoint
Timepoint [12] 0 0
Baseline, Endpoint (Month 12 or last post-baseline visit)
Secondary outcome [13] 0 0
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Emotional Well-Being Domain Score at Endpoint
Timepoint [13] 0 0
Baseline, Endpoint (Month 12 or last post-baseline visit)
Secondary outcome [14] 0 0
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Stigma Domain Score at Endpoint
Timepoint [14] 0 0
Baseline, Endpoint (Month 12 or last post-baseline visit)
Secondary outcome [15] 0 0
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Social Support Domain Score at Endpoint
Timepoint [15] 0 0
Baseline, Endpoint (Month 12 or last post-baseline visit)
Secondary outcome [16] 0 0
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Cognition Domain Score at Endpoint
Timepoint [16] 0 0
Baseline, Endpoint (Month 12 or last post-baseline visit)
Secondary outcome [17] 0 0
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Communication Domain Score at Endpoint
Timepoint [17] 0 0
Baseline, Endpoint (Month 12 or last post-baseline visit)
Secondary outcome [18] 0 0
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Bodily Discomfort Domain Score at Endpoint
Timepoint [18] 0 0
Baseline, Endpoint (Month 12 or last post-baseline visit)
Secondary outcome [19] 0 0
Change From Baseline in EuroQol Quality of Life Scale (EQ-5D) Summary Index at Endpoint
Timepoint [19] 0 0
Baseline, Endpoint (Month 12 or last post-baseline visit)
Secondary outcome [20] 0 0
Change From Baseline in EuroQol Quality of Life Scale (EQ-5D) Visual Analogue Scale (VAS) at Endpoint
Timepoint [20] 0 0
Baseline, Endpoint (Month 12 or last post-baseline visit)
Secondary outcome [21] 0 0
Change From Baseline in Zarit Burden Interview (ZBI) Total Score at Endpoint
Timepoint [21] 0 0
Baseline, Endpoint (Month 12 months or last post-baseline visit)

Eligibility
Key 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
Minimum age
30 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2012
Sample size
Target
Accrual to date
Final
62
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
District of Columbia
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Kentucky
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
Missouri
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
Ohio
Country [11] 0 0
United States of America
State/province [11] 0 0
Vermont
Country [12] 0 0
Germany
State/province [12] 0 0
Bochum
Country [13] 0 0
Germany
State/province [13] 0 0
Bremerhaven
Country [14] 0 0
Germany
State/province [14] 0 0
Hanover
Country [15] 0 0
Germany
State/province [15] 0 0
Tuebingen
Country [16] 0 0
New Zealand
State/province [16] 0 0
Auckland
Country [17] 0 0
New Zealand
State/province [17] 0 0
Hamilton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AbbVie (prior sponsor, Abbott)
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Quintiles, Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Long term safety and efficacy (12 months) of levodopa-carbidopa intestinal gel.
Trial website
https://clinicaltrials.gov/study/NCT00360568
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janet Benesh
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00360568