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Completed

NCT Number: NCT01484990

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

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

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

30 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Levodopa-Carbidopa

Drug

Intestinal Gel

Primary outcomes

  1. Profile of Pharmacokinetics

    Time frame: 5mins, then every 30 minutes up to 8 hours (0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8 hour), 12, 16 (immediately after flushing the tube), 17, 18, and 19 hours.

    Levodopa, Carbidopa and Metabolite:Cmax, Cmin, Area Under Curve, T max, half life, peak-trough fluctuation.

  2. Safety and Tolerability Data Assessments (e.g., clinical laboratory tests, orthostatic vitals, adverse events assessment, physical exam)

    Time frame: 2 days

    Evaluation of orthostatic vitals signs, ECGs, and adverse event monitoring (Screening, Day -1, Day 1, Day 2), clinical lab testing and physical exam (Screening and Day 2)

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Collaborators

  • Quintiles, Inc.

Registry information

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Dec 5, 2011
Registry last updated
Nov 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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