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

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00640952
• Other study ID #: H-19781
• Status: Withdrawn
• Phase: N/A
• First received: December 28, 2007
• Last updated: November 10, 2015
• Start date: August 2006
• Est. completion date: September 2008

Study information

• Verified date: November 2015
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Compulsive Behavior
• Obsessive-Compulsive Disorder
• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• acamprosate
333 mg 2 tabs tid

Locations

Country	Name	City	State
United States	PDCMDC 6550 Fannin, Suite 1801	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Baylor College of Medicine	National Parkinson Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	safety and efficacy compared to baseline scores		6 months	Yes
Secondary	change from baseline assessment tools used in the study		6 months	Yes

External Links

•   Parkinson's Disease Center and Movement Disorders Clinic