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

NCT00335153 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 354

Last updated 2015-01-16

Study results available
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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.

Conditions

  • Advanced Parkinson's Disease

Interventions

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

Sponsors & Collaborators

  • Quintiles, Inc.

    collaborator INDUSTRY

  • AbbVie (prior sponsor, Abbott)

    lead INDUSTRY

Principal Investigators

  • Janet Benesh · AbbVie

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • United States
  • Australia
  • Canada
  • Czechia
  • Finland
  • Germany
  • Israel
  • Italy
  • Netherlands
  • New Zealand
  • Poland
  • Portugal
  • Russia
  • Spain
  • Thailand
  • United Kingdom

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 NCT00335153 on ClinicalTrials.gov