Parkinson's DiseaseNCT00640952
Acamprosate for Treatment of Compulsive Behaviors and Craving in Parkinson's Disease
A study testing acamprosate in people with Parkinson's Disease, run by Baylor College of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- acamprosate
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to Sep 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
PDCMDC 6550 Fannin, Suite 1801
Houston, Texas, 77030
About this study
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
- Being tested
- acamprosate
- Keywords
- Parkinson's disease, impulse control behaviors, dopa-dysregulation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acamprosateDrug
333 mg 2 tabs tid
What is being measured
The primary outcome is the main question the study is designed to answer.
safety and efficacy compared to baseline scores
Measured: 6 months
Secondary outcomes (1)
change from baseline assessment tools used in the study
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2008 (estimated)
- Study startAug 2006
- Primary completionSep 2008
- Study completionSep 2008
Why it stopped: PI left site
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Parkinson Foundation
- Responsible party
- Principal investigator, Joohi Jimenez-Shahed, Baylor College of Medicine
- Investigators
- Joohi Jimenez-Shahed, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00640952
- Sponsor's protocol ID
- H-19781
- Status last verified
- Nov 2015
- First submitted
- 28 Dec 2007
- Last updated
- 13 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acamprosate for Treatment of Compulsive Behaviors and Craving in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT00640952
- Acronym / sponsor ID
- H-19781
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's disease, impulse control behaviors, dopa-dysregulation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI left site
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- National Parkinson Foundation
- Study start
- Aug 2006
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 21 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acamprosate333 mg 2 tabs tid | Drug | – |
Primary outcome
safety and efficacy compared to baseline scores
Time frame: 6 months
1 secondary outcome
change from baseline assessment tools used in the study
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2015.
- Parkinson's Disease Center and Movement Disorders ClinicLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joohi Jimenez-Shahed, MD principal investigator
Baylor College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acamprosate in people with Parkinson's Disease, run by Baylor College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
safety and efficacy compared to baseline scores (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2015.