Acamprosate for Treatment of Compulsive Behaviors and Craving in Parkinson's Disease

This study has been withdrawn prior to enrollment.
(PI left site)
Sponsor:
Collaborator:
National Parkinson Foundation
Information provided by:
Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00640952
First received: December 28, 2007
Last updated: March 12, 2009
Last verified: March 2009
  Purpose

The purpose of this study is to determine how many patients with Parkinson's disease have compulsive behaviors, and what types of behaviors they have. This study will also determine if acamprosate can be used to treat compulsive behaviors in Parkinson's disease patients.


Condition Intervention
Parkinson's Disease
Drug: acamprosate

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Acamprosate for Treatment of Compulsive Behaviors and Craving in Parkinson's Disease

Resource links provided by NLM:


Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • safety and efficacy compared to baseline scores [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • change from baseline assessment tools used in the study [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 400
Study Start Date: August 2006
Estimated Study Completion Date: September 2008
Estimated Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: acamprosate
    333 mg 2 tabs tid
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Idiopathic Parkinson's disease
  2. Active dopaminergic therapy at stable dose for one month (levodopa or dopamine agonist)
  3. Able and willing to complete Rating Scales
  4. Presence of one or more compulsive behavior based on responses to Rating Scales (defined as >5 on the SOGS; >17 on the YBOCS-SV and YBOCS-CUV; >1.7 on the SCS for women and >2.1 on the SCS for men; >15 on the YBOCS-BE, >5.5 on the CQ).
  5. Written informed consent

Inclusion criteria (controls):

  1. No significant psychiatric disease
  2. Able and willing to complete Rating Scales
  3. Written informed consent

Exclusion Criteria:

  1. No anticipated need for adjustment of medications for Parkinson's disease
  2. Current participation in another clinical study
  3. History of unstable psychiatric disease (as determined by the Principal Investigator)
  4. Women of childbearing age not using appropriate contraceptive methods (oral contraceptives, condoms, surgery)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00640952

Locations
United States, Texas
PDCMDC 6550 Fannin, Suite 1801
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
National Parkinson Foundation
Investigators
Principal Investigator: Joohi Jimenez-Shahed, MD Baylor College of Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: Joohi Jimenez-Shahed, MD, Baylor College of medicine
ClinicalTrials.gov Identifier: NCT00640952     History of Changes
Other Study ID Numbers: H-19781
Study First Received: December 28, 2007
Last Updated: March 12, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Baylor College of Medicine:
Parkinson's disease
impulse control behaviors
dopa-dysregulation

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Compulsive Behavior
Impulsive Behavior
Acamprosate
Alcohol Deterrents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 08, 2014