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

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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

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

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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