NCT00660673

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

Open-Label Continuation Treatment Study With Levodopa - Carbidopa Intestinal Gel In Subjects With Advanced Parkinson's Disease And Severe Motor-Fluctuations Who Have Exhibited A Persistent And Positive Effect To Treatment In Previous Studies

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 262 (actual)
• Sponsor: AbbVie · Industry
• Sex: —
• Age: 30 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to provide continued access to levodopa-carbidopa intestinal gel (LCIG), to participants who have already participated in an open-label efficacy and safety study with the same treatment (Study S187.3.003 \[NCT00360568\] or Study S187.3.004 \[NCT00335153\]).

Conditions

• Advanced Parkinson's Disease

Interventions

Type	Name	Description
DRUG	Levodopa-Carbidopa Intestinal Gel (LCIG)	LCIG for upper-intestinal infusion is a suspension of levodopa (20 mg/mL) and carbidopa (5 mg/mL) in an aqueous gel that is dispensed in a medication cassette reservoir containing 100 mL of LCIG.
DEVICE	CADD-Legacy® 1400 ambulatory infusion pump	Portable infusion pump (CADD-Legacy Pump Model 1400) connected to the LCIG medication cassette reservoir.
DEVICE	Percutaneous Endoscopic Gastrostomy with jejunal extension tube (PEG-J)	All participants previously had a PEG-J placed in one of the prior LCIG studies.

Timeline

• Start date: 2009-11-13
• Primary completion: 2021-11-30
• Completion: 2021-11-30
• First posted: 2008-04-17
• Last updated: 2022-12-02
• Results posted: 2022-12-02

Locations

61 sites across 11 countries: United States, Australia, Canada, Czechia, Israel, New Zealand, Poland, Portugal, Russia, Thailand, United Kingdom

Regulatory

• FDA-regulated drug study