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

This study has been completed.
Sponsor:
Collaborator:
Quintiles
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT01484990
First received: July 28, 2011
Last updated: December 2, 2011
Last verified: November 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Parkinson Disease
 Drug: Levodopa-Carbidopa
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Pharmacokinetic Study of Levodopa and Carbidopa Intestinal Gel in Subjects With Advanced Parkinson's Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    Levodopa, Carbidopa and Metabolite:Cmax, Cmin, Area Under Curve, T max, half life, peak-trough fluctuation.

  • Safety and Tolerability Data Assessments (e.g., clinical laboratory tests, orthostatic vitals, adverse events assessment, physical exam) [ Time Frame: 2 days ] [ Designated as safety issue: Yes ]
    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)


Enrollment: 19
Study Start Date: April 2010
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Levodopa-Carbidopa
Intestinal Gel

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01484990

Locations
Germany
Site Reference ID/Investigator# 47063
Bremerhaven, Germany, 27574
Sweden
Site Reference ID/Investigator# 47064
Uppsala, Sweden, 75185
Sponsors and Collaborators
Abbott
Quintiles
Investigators
Study Director: Janet Benesh Abbott
  More Information

No publications provided

Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01484990     History of Changes
Other Study ID Numbers: S187.1.002, 2009-016837-84
Study First Received: July 28, 2011
Last Updated: December 2, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Sweden: Medical Products Agency

Keywords provided by Abbott:
Parkinson's Disease
levodopa
carbidopa
Duodopa
intestinal gel

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Carbidopa
Levodopa
Carbidopa, levodopa drug combination
Antiparkinson Agents
 Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Dopamine Agonists
Adjuvants, Immunologic
Immunologic Factors

ClinicalTrials.gov processed this record on May 19, 2013