CClinicalTrials.gg
WithdrawnNCT00640952Updated Nov 13, 2015

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

An interventional study of acamprosate in Parkinson's Disease, sponsored by Baylor College of Medicine. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-11-13.

Sponsored by Baylor College of Medicine · Not applicable, Interventional, and Treatment

Why this study was withdrawn
PI left site
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Parkinson's Disease

Keywords

  • Parkinson's disease
  • impulse control behaviors
  • dopa-dysregulation
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility 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)
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
0 participants (actual)

Interventions

  • Drugacamprosate

    333 mg 2 tabs tid

05

What researchers measure

Primary outcomes

  1. safety and efficacy compared to baseline scores

    Time frame: 6 months

Secondary outcomes

  1. change from baseline assessment tools used in the study

    Time frame: 6 months

06

Study locations

1 site
  • PDCMDC 6550 Fannin, Suite 1801
    Houston, Texas 77030, United States
07

References and documents

08

Registry details

Key details

Study ID
NCT00640952
Lead sponsor
Baylor College of Medicine
Collaborators
National Parkinson Foundation
Responsible party
Joohi Jimenez-Shahed (Principal Investigator, Baylor College of Medicine) — Principal investigator
First posted
Mar 21, 2008
Start date
Aug 2006
Primary completion
Sep 2008
Completion
Sep 2008
Last update
Nov 13, 2015

Study contacts

Joohi Jimenez-Shahed, MD
principal investigator · Baylor College of Medicine

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion