A Study to Assess the Safety and Efficacy of Levodopa-carbidopa Intestinal Gel (LCIG) for the Treatment of Non-motor Symptoms in Patients With Advanced Parkinson's Disease

PHASE3CompletedINTERVENTIONAL
Enrollment

39

Participants

Timeline

Start Date

March 31, 2013

Primary Completion Date

March 31, 2015

Study Completion Date

December 31, 2015

Conditions
Advanced Parkinson's Disease
Interventions
DRUG

Levodopa-Carbidopa Intestinal Gel

"Levodopa-carbidopa intestinal gel (LCIG) for upper-intestinal infusion is a suspension of levodopa (20 mg/mL) and carbidopa monohydrate (5 mg/mL) in an aqueous gel, administered continuously by a portable pump via a percutaneous endoscopic gastrojejunostomy (PEG-J) tube.~The rate of LCIG infusion was expected to be within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances over a period of 16 consecutive hours."

PROCEDURE

Percutaneous Endoscopic Gastrostomy with Jejunal Extension (PEG-J)

DRUG

Levodopa-carbidopa Immediate Release (LC-IR) Tablets

After LCIG initiation, participants could take prescribed oral levodopa-carbidopa immediate or continuous release (i.e., oral LC prescribed by the investigator) for nighttime use.

All Listed Sponsors
lead

AbbVie (prior sponsor, Abbott)

INDUSTRY

NCT01736176 - A Study to Assess the Safety and Efficacy of Levodopa-carbidopa Intestinal Gel (LCIG) for the Treatment of Non-motor Symptoms in Patients With Advanced Parkinson's Disease | Biotech Hunter | Biotech Hunter