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

NCT00357994 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2015-01-16

Study results available
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Summary

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.

Conditions

  • Advanced Parkinson's Disease

Interventions

DRUG

Levodopa carbidopa intestinal gel (LCIG)

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 per/hour)

DRUG

Placebo gel

DRUG

Levodopa carbidopa (LC) oral encapsulated immediate release (IR) tablets

DRUG

Placebo (PBO) oral capsules

DEVICE

CADD-Legacy® 1400 ambulatory infusion pump

DEVICE

PEG tube

percutaneous endoscopic gastrostomy tube

DEVICE

J-tube

jejunal tube

Sponsors & Collaborators

  • Quintiles, Inc.

    collaborator INDUSTRY

  • AbbVie (prior sponsor, Abbott)

    lead INDUSTRY

Principal Investigators

  • Janet Benesh · AbbVie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2011-10-31
Completion
2011-10-31

Countries

  • United States
  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00357994 on ClinicalTrials.gov