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

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ClinicalTrials.gov Identifier: NCT00640952
Recruitment Status : Withdrawn (PI left site)
First Posted : March 21, 2008
Last Update Posted : November 13, 2015
Sponsor:
Collaborator:
National Parkinson Foundation
Information provided by (Responsible Party):
Joohi Jimenez-Shahed, Baylor College of Medicine

December 28, 2007
March 21, 2008
November 13, 2015
August 2006
September 2008   (Final data collection date for primary outcome measure)
safety and efficacy compared to baseline scores [ Time Frame: 6 months ]
Same as current
Complete list of historical versions of study NCT00640952 on ClinicalTrials.gov Archive Site
change from baseline assessment tools used in the study [ Time Frame: 6 months ]
Same as current
Not Provided
Not Provided
 
Acamprosate for Treatment of Compulsive Behaviors and Craving in Parkinson's Disease
Acamprosate for Treatment of Compulsive Behaviors and Craving in Parkinson's Disease
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.
Not Provided
Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Parkinson's Disease
Drug: acamprosate
333 mg 2 tabs tid
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
400
September 2008
September 2008   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00640952
H-19781
No
Not Provided
Not Provided
Joohi Jimenez-Shahed, Baylor College of Medicine
Baylor College of Medicine
National Parkinson Foundation
Principal Investigator: Joohi Jimenez-Shahed, MD Baylor College of Medicine
Baylor College of Medicine
November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP