Expired Study
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Houston, Texas 77030


Purpose:

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.


Criteria:

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 is Available At:


Original ID:

H-19781


NCT ID:

NCT00640952


Secondary ID:


Study Acronym:


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


Overall Status:

Withdrawn


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Baylor College of Medicine


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:

PI left site


Study Type:

Interventional


Study Design:

Endpoint Classification: Safety/Efficacy Study, In


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

0


Enrollment Type:

Actual


Overall Contact Information

Official Name:Joohi Jimenez-Shahed, MD
Principal Investigator
Baylor College of Medicine

Study Dates

Start Date:August 2006
Completion Date:September 2008
Completion Type:Actual
Primary Completion Date:September 2008
Primary Completion Type:Actual
Verification Date:November 2015
Last Changed Date:November 10, 2015
First Received Date:December 28, 2007

Study Outcomes

Outcome Type:Primary Outcome
Measure:safety and efficacy compared to baseline scores
Time Frame:6 months
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:change from baseline assessment tools used in the study
Time Frame:6 months
Safety Issues:True

Study Interventions

Intervention Type:Drug
Name:acamprosate
Description:333 mg 2 tabs tid

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Baylor College of Medicine
Agency Class:Other
Agency Type:Collaborator
Agency Name:National Parkinson Foundation

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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