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

NCT ID: NCT01484990

Last Updated: 2017-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2010-09-30

Brief Summary

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

Detailed Description

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Conditions

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Parkinson Disease

Keywords

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Parkinson's Disease levodopa carbidopa Duodopa intestinal gel

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

Levodopa-Carbidopa

Intervention Type DRUG

Intestinal Gel

Interventions

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Levodopa-Carbidopa

Intestinal Gel

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Quintiles, Inc.

INDUSTRY

Sponsor Role collaborator

AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janet Benesh

Role: STUDY_DIRECTOR

Abbott

Countries

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Germany Sweden

References

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Nyholm D, Odin P, Johansson A, Chatamra K, Locke C, Dutta S, Othman AA. Pharmacokinetics of levodopa, carbidopa, and 3-O-methyldopa following 16-hour jejunal infusion of levodopa-carbidopa intestinal gel in advanced Parkinson's disease patients. AAPS J. 2013 Apr;15(2):316-23. doi: 10.1208/s12248-012-9439-1. Epub 2012 Dec 11.

Reference Type RESULT
PMID: 23229334 (View on PubMed)

Other Identifiers

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2009-016837-84

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

S187.1.002

Identifier Type: -

Identifier Source: org_study_id