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

NCT00640952 | Withdrawn

• 1 other identifier: H-19781
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson's Disease

Keywords

Parkinson's disease; impulse control behaviors; dopa-dysregulation

Outcome Measures

Primary Outcomes (1)

• safety and efficacy compared to baseline scores

  6 months

Secondary Outcomes (1)

• change from baseline assessment tools used in the study

  6 months

Interventions

acamprosate DRUG

333 mg 2 tabs tid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• No significant psychiatric disease
• Able and willing to complete Rating Scales
• Written informed consent

You may not qualify if:

• 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)

Sponsors & Collaborators

• Baylor College of Medicine: lead
• National Parkinson Foundation: collaborator

Study Sites (1)

PDCMDC 6550 Fannin, Suite 1801

Houston, Texas, 77030, United States

Location

Related Links

• Parkinson's Disease Center and Movement Disorders Clinic

MeSH Terms

Conditions

Parkinson Disease

Interventions

Acamprosate

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Taurine; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Joohi Jimenez-Shahed, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 28, 2007
• First Posted: March 21, 2008
• Study Start: August 1, 2006
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: November 13, 2015

Record last verified: 2015-11

Locations

US (1)