NCT00360568

Safety/Efficacy Study of Levodopa-Carbidopa Intestinal Gel in Parkinson's Subjects

Open-Label, 12-Month Safety and Efficacy Study of Levodopa - Carbidopa Intestinal Gel in Levodopa-Responsive Parkinson's Disease Subjects

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: AbbVie (prior sponsor, Abbott) · Industry
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

Summary

Long term safety and efficacy (12 months) of levodopa-carbidopa intestinal gel.

Detailed description

Study S187.3.003 (NCT00360568) is a Phase 3, 12-month, open-label, multicenter continuation treatment study of the safety, tolerability, and efficacy of levodopa-carbidopa intestinal gel (LCIG) in the treatment of participants with levodopa-responsive Parkinson's disease (PD) with persistent motor fluctuations despite optimized treatment with available PD medications. All participants received LCIG. Only participants who completed 12 weeks of double-blind, double-dummy treatment in Study S187.3.001 or S187.3.002 (NCT00357994/ NCT00660387) qualified for enrollment in this 12-month continuation treatment study.

Conditions

• Dyskinesias
• Parkinson's Disease
• Severe Motor Fluctuations

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: 2009-06-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2006-08-04
• Last updated: 2015-01-16
• Results posted: 2015-01-16

Locations

22 sites across 3 countries: United States, Germany, New Zealand