Study of Efficacy, Safety and Tolerability of Levodopa-Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Subjects
Information source: AbbVie
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Advanced Parkinson's Disease
Intervention: Levodopa carbidopa intestinal gel (LCIG) (Drug); Placebo Gel (Drug); Levodopa-carbidopa (LC) oral encapsulated immediate release (IR) tablets (Drug); Placebo (PBO) oral capsules (Drug); CADD-Legacy® 1400 ambulatory infusion pump (Device); PEG tube (Device); J-tube (Device)
Phase: Phase 3
Status: Completed
Sponsored by: AbbVie (prior sponsor, Abbott) Official(s) and/or principal investigator(s): Janet Benesh, Study Director, Affiliation: AbbVie
Summary
The primary objective of this study was to demonstrate the superiority of levodopa -
carbidopa intestinal gel over treatment with optimized oral levodopa/carbidopa during 12
weeks.
Clinical Details
Official title: A Randomized, Double-Blind, Double-Dummy, Efficacy, Safety and Tolerability Study of Levodopa - Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Subjects Receiving Optimized Treatments With Parkinson Medicinal Products Who Continue to Experience Persistent Motor Fluctuations
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Change From Baseline to Week 12 in Average Daily Normalized "Off" Time
Secondary outcome: Change From Baseline in Average Daily Normalized "On" Time Without Troublesome Dyskinesia at Week 12Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Summary Index at Week 12 Clinical Global Impression - Status (CGI-S) Score at Baseline and Clinical Global Impression - Improvement (CGI-I) Score at Week 12 Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score at Week 12 Change From Baseline in UPDRS Part III Score at Week 12 Change From Baseline in EuroQual Quality of Life - 5 Dimensions (EQ-5D) Summary Index at Week 12 Change From Baseline in Zarit Burden Interview (ZBI) Total Score at Week 12 Change From Baseline in Average Daily Normalized "On" Time With Troublesome Dyskinesia at Week 12 Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Mobility Domain Score at Week 12 Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Activities of Daily Living Domain Score at Week 12 Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Emotional Well-Being Domain Score at Week 12 Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Stigma Domain Score at Week 12 Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Social Support Domain Score at Week 12 Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Cognition Domain Score at Week 12 Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Communication Domain Score at Week 12 Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Bodily Discomfort Domain Score at Week 12 Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part I Score at Week 12 Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Score at Week 12 Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part IV Questions 32, 33, and 34 at Week 12 Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Total Score at Week 12 Change From Baseline in EuroQol Quality of Life Scale (EQ-5D) Visual Analogue Scale (VAS) at Week 12 Employment Impairment (EMP) I Status at Baseline Employment Impairment (EMP) II Status at Week 12
Detailed description:
Study S187. 3.001 (NCT00357994) and Study S187. 3.002 (NCT00660387) were 2 identically
designed, Phase 3, 12-week, randomized, double-blind, double-dummy, parallel-group,
multicenter studies recruiting subjects from distinct sites. These studies evaluated the
efficacy, safety, and tolerability of levodopa-carbidopa intestinal gel (LCIG) in the
treatment of levodopa-responsive subjects with advanced PD who had persistent severe motor
fluctuations, despite optimized treatment with oral levodopa-carbidopa, concomitant with
other available antiparkinsonian medications. Participants were randomized to either LCIG
active gel + placebo capsules or levodopa-carbidopa immediate release (IR) active capsules +
placebo gel. Both treatment arms received the percutaneous endoscopic gastrostomy with
jejunal extension (PEG-J) procedure for gel administration, active LCIG or placebo gel. Data
from these 2 studies were combined for analysis. The decision to combine the study data for
analysis was made before enrollment was completed for both studies.
Eligibility
Minimum age: 30 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Idiopathic Parkinson's disease (PD) according to United Kingdom Parkinson's Disease
Society (UKPDS) Brain Bank Criteria
- Levodopa-responsive participants who demonstrate some identifiable 'on response,'
established by Investigator observation
- Demonstrate severe motor fluctuations in spite of individually optimized treatment
and where therapy options are indicated
Exclusion Criteria:
- Diagnosis is unclear or a suspicion of other parkinsonian syndromes exists such as
secondary parkinsonism
- Undergone surgery for the treatment of PD
- Contraindications to levodopa
- Subjects with any neurological deficit that may interfere with the study assessments
Locations and Contacts
Site Reference ID/Investigator# 45904, Auckland 1010, New Zealand
Site Reference ID/Investigator# 45902, Christchurch 8011, New Zealand
Site Reference ID/Investigator# 45905, Hamilton 3204, New Zealand
Site Reference ID/Investigator# 45931, Birmingham, Alabama 35222, United States
Site Reference ID/Investigator# 45910, Fountain Valley, California 92708, United States
Site Reference ID/Investigator# 45925, Oceanside, California 92056, United States
Site Reference ID/Investigator# 45912, Port Charlotte, Florida 33890, United States
Site Reference ID/Investigator# 45935, Chicago, Illinois 60611, United States
Site Reference ID/Investigator# 45930, Lexington, Kentucky 40536, United States
Site Reference ID/Investigator# 45934, New York, New York 10032, United States
Site Reference ID/Investigator# 45929, Winston-Salem, North Carolina 27157, United States
Site Reference ID/Investigator# 45908, Cincinnati, Ohio 45267, United States
Site Reference ID/Investigator# 45922, Cleveland, Ohio 44195-0001, United States
Site Reference ID/Investigator# 45915, Kirkland, Washington 98034, United States
Additional Information
Starting date: December 2009
Last updated: January 12, 2015
|