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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 12

Change 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

Page last updated: August 23, 2015

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