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

NCT00360568 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2015-01-16

Study results available
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Summary

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

Conditions

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
2009-06-30
Primary Completion
2012-10-31
Completion
2012-10-31

Countries

  • United States
  • Germany
  • New Zealand

Study Locations

More Related Trials

Entities

Diseases

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 NCT00360568 on ClinicalTrials.gov