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

• Sponsor: Baylor College of Medicine (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT00640952
• Collaborator: National Parkinson Foundation (Other)
• Enrollment: 0
• Location: 1
• Duration (Months): 25
• Patients Per Site Per Month: 0

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson's Disease	Drug: acamprosate	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Acamprosate for Treatment of Compulsive Behaviors and Craving in Parkinson's Disease
• Study Start Date: Aug 1, 2006
• Actual Primary Completion Date: Sep 1, 2008
• Actual Study Completion Date: Sep 1, 2008

Outcome Measures

Primary Outcome Measures

1. safety and efficacy compared to baseline scores [6 months]

Secondary Outcome Measures

1. change from baseline assessment tools used in the study [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Parkinson's Disease Center and Movement Disorders Clinic

Publications

None provided.

• Responsible Party: Joohi Jimenez-Shahed, Principal Investigator, Baylor College of Medicine
• ClinicalTrials.gov Identifier: NCT00640952
• Other Study ID Numbers: H-19781
• First Posted: Mar 21, 2008
• Last Update Posted: Nov 13, 2015
• Last Verified: Nov 1, 2015

• Keywords provided by Joohi Jimenez-Shahed, Principal Investigator, Baylor College of Medicine: Parkinson's disease; impulse control behaviors; dopa-dysregulation
• Additional relevant MeSH terms: Parkinson Disease; Compulsive Behavior; Acamprosate

Study Results

No Results Posted as of Nov 13, 2015