Conditions: Advanced Parkinson's Disease
Keywords: carbidopa levodopa-carbidopa levodopa levodopa/carbidopa suspension dyskinesia Duodopa levodopa-carbidopa intestinal gel Severe Motor Fluctuations DUOPA
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 36
Healthy volunteers: no

Brief 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.

Arms:
arm 1: Participants were randomized to LCIG (levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG. arm 2: Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.

Interventions: intervention 1: Levodopa carbidopa intestinal gel (LCIG) intervention 2: Placebo gel intervention 3: Levodopa carbidopa (LC) oral encapsulated immediate release (IR) tablets intervention 4: Placebo (PBO) oral capsules intervention 5: CADD-Legacy® 1400 ambulatory infusion pump intervention 6: PEG tube intervention 7: J-tube
Intervention descriptions: intervention 1: 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) intervention 2: None intervention 3: None intervention 4: None intervention 5: None intervention 6: percutaneous endoscopic gastrostomy tube intervention 7: jejunal tube

Protocol document: