Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
5 participants
INTERVENTIONAL
2014-05-31
2017-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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PF-04457845
PF-04457845 will be administered orally at 4mg daily for four weeks.
PF-04457845
PF-04457845 will be administered orally at 4mg daily for four weeks.
Placebo
Placebo (sugar pill) will be administered orally at 4mg daily for four weeks.
Placebo
Placebo will be administered orally at 4mg daily for four weeks.
Interventions
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PF-04457845
PF-04457845 will be administered orally at 4mg daily for four weeks.
Placebo
Placebo will be administered orally at 4mg daily for four weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Meet DSM IV criteria for the diagnosis of Tourette's syndrome
* Significant current tic symptoms: YGTSS total tic score greater than or equal to 22 at baseline
* On stable psychiatric medication regimen for a minimum of 4 weeks prior to beginning the trial.
* Accepted method of birth control
Exclusion Criteria
* Current use of medications that have significant effects on the cannabinoid or dopamine systems. Subjects will be specifically excluded for recent use (within last 8 weeks) of antipsychotic medications, dopamine agonists or psychostimulants.
* Recent change (less than 4 weeks) in other medications that have potential effects on tic severity (such as alpha-2 agonists (guanfacine, clonidine or prazosin), SSRIs, clomipramine, naltrexone, lithium, anxiolytics, topiramate, baclofen etc.). Medication change is defined to include dose changes or medication discontinuation.
* Recent change in behavioral treatment for Tourette syndrome or comorbid conditions (i.e. OCD) within the last 4 weeks or initiation of behavioral therapy for tics within the last 12 weeks.
* Positive pregnancy test or drug screening test
* History of cannabis dependence
* Significant Medical Comorbidity
18 Years
60 Years
ALL
No
Sponsors
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Tourette Association of America
OTHER
Yale University
OTHER
Responsible Party
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Principal Investigators
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Michael H. Bloch, MD, MS
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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Connecticut Mental Health Center
New Haven, Connecticut, United States
Countries
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Other Identifiers
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1403013669
Identifier Type: -
Identifier Source: org_study_id
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