A Pharmacokinetic Study of Levodopa and Carbidopa Intestinal Gel in Subjects With Advanced Parkinson's Disease

AbbVie

Status and phase: Completed; Phase 1

Conditions: Parkinson Disease

Treatments: Drug: Levodopa-Carbidopa

Study type: Interventional

Funder types: Industry

Identifiers

NCT01484990

S187.1.002

2009-016837-84 (EudraCT Number)

Details and patient eligibility

About

A Pharmacokinetic Study of Levodopa and Carbidopa Intestinal Gel in Subjects with Advanced Parkinson's Disease.

Enrollment: 19 patients

Sex: All

Ages: 30 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

1. Male or female subjects at least 30 years old;
2. Subjects with advanced Parkinson's disease who are already on LCIG (Duodopa®) for at least 30 days;
3. Body mass index range from 18.0 to 30.0 kg/m2

Exclusion Criteria

1. Subjects who are considered to be violent or subjects considered at suicidal risk by the investigator;
2. Clinically significant abnormal laboratory data at baseline or any abnormal laboratory value that could interfere with the study assessments;
3. 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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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19 participants in 1 patient group

1

Experimental group

Treatment:

Drug: Levodopa-Carbidopa