Status:
COMPLETED
A Pharmacokinetic Study of Levodopa and Carbidopa Intestinal Gel in Subjects With Advanced Parkinson's Disease
Lead Sponsor:
AbbVie
Collaborating Sponsors:
Quintiles, Inc.
Conditions:
Parkinson Disease
Eligibility:
All Genders
30-99 years
Phase:
PHASE1
Brief Summary
A Pharmacokinetic Study of Levodopa and Carbidopa Intestinal Gel in Subjects with Advanced Parkinson's Disease.
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Male or female subjects at least 30 years old;
- Subjects with advanced Parkinson's disease who are already on LCIG (Duodopa®) for at least 30 days;
- Body mass index range from 18.0 to 30.0 kg/m2
- Exclusion Criteria
- Subjects who are considered to be violent or subjects considered at suicidal risk by the investigator;
- Clinically significant abnormal laboratory data at baseline or any abnormal laboratory value that could interfere with the study assessments;
- Subjects with serious symptomatic cerebral disease, cerebrovascular disease, focal neurological lesions (previous brain surgery), any acute brain trauma requiring treatment with anticonvulsant therapy, or acute stroke
Exclusion
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT01484990
Start Date
April 1 2010
End Date
September 1 2010
Last Update
November 21 2017
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