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

AbbVie

Status and phase: Completed; Phase 3

Conditions: Advanced Parkinson's Disease

Treatments: Drug: Placebo Gel; Device: PEG tube; Device: J-tube; Drug: Levodopa-carbidopa (LC) oral encapsulated immediate release (IR) tablets; Drug: Levodopa carbidopa intestinal gel (LCIG); Device: CADD-Legacy® 1400 ambulatory infusion pump; Drug: Placebo (PBO) oral capsules

Study type: Interventional

Funder types: Industry

Identifiers

NCT00660387

2007-003814-32 (EudraCT Number)

S187.3.002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 35 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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35 participants in 2 patient groups

Levodopa-Carbidopa Intestinal Gel (LCIG) + Placebo Capsules

Experimental group

Description:

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.

Treatment:

Device: CADD-Legacy® 1400 ambulatory infusion pump

Drug: Placebo (PBO) oral capsules

Drug: Levodopa carbidopa intestinal gel (LCIG)

Device: J-tube

Device: PEG tube

Placebo Gel + Levodopa-Carbidopa Capsules

Active Comparator group

Description:

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.

Treatment:

Device: CADD-Legacy® 1400 ambulatory infusion pump

Drug: Levodopa-carbidopa (LC) oral encapsulated immediate release (IR) tablets

Device: J-tube

Device: PEG tube

Drug: Placebo Gel