NCT00335153

Levodopa-Carbidopa Intestinal Gel Open-Label Study in Advanced Parkinson's Disease

An Open-Label, 12-Month Safety and Efficacy Study of Levodopa - Carbidopa Intestinal Gel in Levodopa-Responsive Subjects With Advanced Parkinson's Disease and Severe Motor Fluctuations Despite Optimized Treatment With Available Parkinson's Disease Medications

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 354 (actual)
• Sponsor: AbbVie (prior sponsor, Abbott) · Industry
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study will be to provide further evidence of the long-term safety and tolerability of levodopa-carbidopa intestinal gel (Duodopa®) over 12-months in participants with advanced Parkinson's disease (PD) and severe motor fluctuations.

Detailed description

The study was composed of a screening period followed by 3 sequential on-treatment periods, as follows: * Screening Period (up to 28 days): determination of eligibility and discontinuation of antiparkinsonian disease medications other than levodopa-carbidopa immediate release (LC-oral) prior to nasojejunal (NJ) tube placement. * NJ Test Period (2 to 14 days): first hospitalization period, Baseline assessments, placement of NJ tube, and optimization of levodopa-carbidopa intestinal gel (LCIG) treatment via NJ tube and infusion pump (participant was hospitalized for NJ tube placement but hospitalization was not required for entire duration of LCIG treatment optimization). * PEG-J Period (2 to 14 days): second hospitalization period; placement of PEG-J tube; further optimization of LCIG treatment. * Post PEG-J Long-Term Treatment Period (Day 28 to Day 378): LCIG administration via a permanent PEG-J tube and infusion pump, with dosage adjusted according to clinical condition.

Conditions

• Advanced Parkinson's Disease

Interventions

Type	Name	Description
DRUG	Levodopa-carbidopa intestinal gel	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/hour).
DEVICE	CADD-Legacy® 1400 ambulatory infusion pump
DEVICE	PEG tube	percutaneous endoscopic gastrostomy tube
DEVICE	J-tube	jejunal tube

Timeline

• Start date: 2008-01-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2006-06-09
• Last updated: 2015-01-16
• Results posted: 2015-01-16

Locations

83 sites across 16 countries: United States, Australia, Canada, Czechia, Finland, Germany, Israel, Italy, Netherlands, New Zealand, Poland, Portugal, Russia, Spain, Thailand, United Kingdom