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

November 10, 2015 updated by: Joohi Jimenez-Shahed, Baylor College of Medicine
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • PDCMDC 6550 Fannin, Suite 1801

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
safety and efficacy compared to baseline scores
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
change from baseline assessment tools used in the study
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baylor College of Medicine

Collaborators

National Parkinson Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

September 1, 2008

Study Registration Dates

First Submitted

December 28, 2007

First Submitted That Met QC Criteria

March 20, 2008

First Posted (Estimate)

March 21, 2008

Study Record Updates

Last Update Posted (Estimate)

November 13, 2015

Last Update Submitted That Met QC Criteria

November 10, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-19781

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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