Back to resultsAcamprosate for Treatment of Compulsive Behaviors and Craving in Parkinson's Disease
Primary Purpose
Parkinson's Disease
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
acamprosate
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's disease, impulse control behaviors, dopa-dysregulation
Eligibility Criteria
Inclusion Criteria:
- Idiopathic Parkinson's disease
- Active dopaminergic therapy at stable dose for one month (levodopa or dopamine agonist)
- Able and willing to complete Rating Scales
- 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).
- Written informed consent
Inclusion criteria (controls):
- No significant psychiatric disease
- Able and willing to complete Rating Scales
- Written informed consent
Exclusion Criteria:
- No anticipated need for adjustment of medications for Parkinson's disease
- Current participation in another clinical study
- History of unstable psychiatric disease (as determined by the Principal Investigator)
- Women of childbearing age not using appropriate contraceptive methods (oral contraceptives, condoms, surgery)
Sites / Locations
- PDCMDC 6550 Fannin, Suite 1801
Outcomes
Primary Outcome Measures
safety and efficacy compared to baseline scores
Secondary Outcome Measures
change from baseline assessment tools used in the study
Full Information
NCT ID
NCT00640952
First Posted
December 28, 2007
Last Updated
November 10, 2015
Sponsor
Baylor College of Medicine
Collaborators
National Parkinson Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00640952
Brief Title
Acamprosate for Treatment of Compulsive Behaviors and Craving in Parkinson's Disease
Official Title
Acamprosate for Treatment of Compulsive Behaviors and Craving in Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Withdrawn
Why Stopped
PI left site
Study Start Date
August 2006 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine
Collaborators
National Parkinson Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson's disease, impulse control behaviors, dopa-dysregulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
acamprosate
Intervention Description
333 mg 2 tabs tid
Primary Outcome Measure Information:
Title
safety and efficacy compared to baseline scores
Time Frame
6 months
Secondary Outcome Measure Information:
Title
change from baseline assessment tools used in the study
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Idiopathic Parkinson's disease
Active dopaminergic therapy at stable dose for one month (levodopa or dopamine agonist)
Able and willing to complete Rating Scales
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).
Written informed consent
Inclusion criteria (controls):
No significant psychiatric disease
Able and willing to complete Rating Scales
Written informed consent
Exclusion Criteria:
No anticipated need for adjustment of medications for Parkinson's disease
Current participation in another clinical study
History of unstable psychiatric disease (as determined by the Principal Investigator)
Women of childbearing age not using appropriate contraceptive methods (oral contraceptives, condoms, surgery)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joohi Jimenez-Shahed, MD
Organizational Affiliation
Baylor College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
PDCMDC 6550 Fannin, Suite 1801
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.jankovic.org
Description
Parkinson's Disease Center and Movement Disorders Clinic
Learn more about this trial
Acamprosate for Treatment of Compulsive Behaviors and Craving in Parkinson's Disease
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