Acamprosate for Treatment of Compulsive Behaviors and Cra... | NCT00640952

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

NCT00640952

Sponsor

Baylor College of Medicine

Status

Withdrawn

Last Update Posted

Nov 13, 2015Estimated

Enrollment

0Actual

Phase

Not Applicable

Conditions

Parkinson's Disease

Interventions

acamprosate

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2015

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

PI left site

Expanded Access Info

Start Date

Aug 2006

Primary Completion Date

Sep 2008Actual

Completion Date

Sep 2008Actual

First Submitted Date

Dec 28, 2007

First Submission Date that Met QC Criteria

Mar 20, 2008

First Posted Date

Mar 21, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 10, 2015

Last Update Posted Date

Nov 13, 2015Estimated

Name	Class
National Parkinson Foundation	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Name	Type	Description	Arm Group Labels	Other Names
acamprosate	Drug	333 mg 2 tabs tid

Measure	Description	Time Frame
safety and efficacy compared to baseline scores		6 months

Measure	Description	Time Frame
change from baseline assessment tools used in the study		6 months

Eligibility Module

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)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Joohi Jimenez-Shahed, MD	Baylor College of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
PDCMDC 6550 Fannin, Suite 1801		Houston	Texas	77030	United States

Label	URL
Parkinson's Disease Center and Movement Disorders Clinic	View source

Condition Browse Module

MeSH Terms

ID	Term
D010300	Parkinson Disease

Ancestor Terms

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077443	Acamprosate

Ancestor Terms

ID	Term
D013654	Taurine
D017738	Alkanesulfonic Acids
D000473	Alkanes
D006839	Hydrocarbons, Acyclic

Browse Leaves

Not provided

Browse Branches

Not provided