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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00360568
• Date of registration: 03/08/2006
• Prospective Registration: Yes
• Primary sponsor: AbbVie (prior sponsor, Abbott)
• 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
• Date of first enrolment: June 2009
• Target sample size: 62
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00360568
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Germany, New Zealand, United States

Contacts

• Name: Janet Benesh
• Affiliation: AbbVie

Key inclusion & exclusion criteria

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)



Age minimum: 30 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Dyskinesias

Parkinson's Disease

Severe Motor Fluctuations

Intervention(s)

Device: J-tube

Device: PEG tube

Device: CADD-Legacy® 1400 ambulatory infusion pump

Drug: Levodopa-carbidopa intestinal gel

Primary Outcome(s)

Number of Participants With Clinically Significant Neurological Examination Findings [Time Frame: up to 12 months]

Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score at Endpoint [Time Frame: Baseline, Endpoint (Month 12 or last post-baseline visit)]

Number of Participants With Confirmed Cases of Melanoma [Time Frame: up to Month 12]

Number of Participants With Potentially Clinically Significant Values for Clinical Chemistry Parameters [Time Frame: 12 months]

Number of Participants With Potentially Clinically Significant Vital Sign Parameters [Time Frame: 12 months]

Number of Participants With Potentially Clinically Significant Values for Hematology Parameters [Time Frame: 12 months]

Number of Participants Taking at Least 1 Concomitant Medication During the Study [Time Frame: 12 months]

Number of Participants With Sleep Attacks at Baseline and Endpoint [Time Frame: Baseline, Endpoint (Month 12 or last post-baseline visit)]

Columbia-Suicide Severity Rating Scale (C-SSRS) Findings [Time Frame: up to 12 months]

Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Deaths and Discontinuations Due to AEs [Time Frame: From study enrollment to the end of study or early termination of treatment, including the removal of PEG-J, plus 30 days.]

Number of Participants With Device Complications [Time Frame: 12 months]

Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Parameters [Time Frame: 12 months]

Summary of Minnesota Impulsive Disorder Interview (MIDI) Assessment of Intense Impulsive Behavior at Baseline (BL) and Post-baseline (PBL) [Time Frame: Baseline, Post-baseline (up to Month 12)]

Secondary Outcome(s)

Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part I Score at Endpoint [Time Frame: Baseline, Endpoint (Month 12 or last post-baseline visit)]

Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Mobility Domain Score at Endpoint [Time Frame: Baseline, Endpoint (Month 12 or last post-baseline visit)]

Change From Baseline in Average Daily "Off" Time at Endpoint [Time Frame: Baseline, Endpoint (Month 12 or last post-baseline visit)]

Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score at Endpoint [Time Frame: Baseline, Endpoint (Month 12 or last post-baseline visit)]

Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Activities of Daily Living Domain Score at Endpoint [Time Frame: Baseline, Endpoint (Month 12 or last post-baseline visit)]

Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Score at Endpoint [Time Frame: Baseline, Endpoint (Month 12 or last post-baseline visit)]

Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Emotional Well-Being Domain Score at Endpoint [Time Frame: Baseline, Endpoint (Month 12 or last post-baseline visit)]

Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Cognition Domain Score at Endpoint [Time Frame: Baseline, Endpoint (Month 12 or last post-baseline visit)]

Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Bodily Discomfort Domain Score at Endpoint [Time Frame: Baseline, Endpoint (Month 12 or last post-baseline visit)]

Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Social Support Domain Score at Endpoint [Time Frame: Baseline, Endpoint (Month 12 or last post-baseline visit)]

Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Score at Endpoint [Time Frame: Baseline, Endpoint (Month 12 or last post-baseline visit)]

Change From Baseline in Average Daily Normalized "On" Time With Troublesome Dyskinesia at Endpoint [Time Frame: Baseline, Endpoint (Month 12 or last post-baseline visit)]

Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Summary Index at Endpoint [Time Frame: Baseline, Endpoint (Month 12 or last post-baseline visit)]

Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score at Endpoint [Time Frame: Baseline, Endpoint (Month 12 or last post-baseline visit)]

Change From Baseline in Average Daily "On" Time Without Troublesome Dyskinesia at Month 12 [Time Frame: Baseline, Endpoint (Month 12 or last post-baseline visit)]

Change From Baseline in EuroQol Quality of Life Scale (EQ-5D) Visual Analogue Scale (VAS) at Endpoint [Time Frame: Baseline, Endpoint (Month 12 or last post-baseline visit)]

Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Communication Domain Score at Endpoint [Time Frame: Baseline, Endpoint (Month 12 or last post-baseline visit)]

Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Stigma Domain Score at Endpoint [Time Frame: Baseline, Endpoint (Month 12 or last post-baseline visit)]

Change From Baseline in Zarit Burden Interview (ZBI) Total Score at Endpoint [Time Frame: Baseline, Endpoint (Month 12 months or last post-baseline visit)]

Clinical Global Impression - Status (CGI-S) Score at Baseline and Clinical Global Impression - Improvement (CGI-I) Score at Endpoint [Time Frame: Baseline, Endpoint (Month 12 or last post-baseline visit)]

Change From Baseline in EuroQol Quality of Life Scale (EQ-5D) Summary Index at Endpoint [Time Frame: Baseline, Endpoint (Month 12 or last post-baseline visit)]

Secondary ID(s)

2006-000578-53

S187.3.003

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Quintiles, Inc.

Results

• Results available: Yes
• Date Posted: 16/01/2015
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00360568