NCT00357994

Study of Efficacy, Safety and Tolerability of Levodopa-Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Subjects

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: AbbVie (prior sponsor, Abbott) · Industry
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Advanced Parkinson's Disease

Interventions

Type	Name	Description
DRUG	Levodopa carbidopa intestinal gel (LCIG)	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 per/hour)
DRUG	Placebo gel
DRUG	Levodopa carbidopa (LC) oral encapsulated immediate release (IR) tablets
DRUG	Placebo (PBO) oral capsules
DEVICE	CADD-Legacy® 1400 ambulatory infusion pump
DEVICE	PEG tube	percutaneous endoscopic gastrostomy tube
DEVICE	J-tube	jejunal tube

Timeline

• Start date: 2009-01-01
• Primary completion: 2011-10-01
• Completion: 2011-10-01
• First posted: 2006-07-28
• Last updated: 2015-01-16
• Results posted: 2015-01-16

Locations

15 sites across 2 countries: United States, Germany