FAAH Inhibitor Trial for Adults With Tourette Syndrome

Study Overview
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Brief Summary
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The purpose of this trial is to examine the safety, tolerability and feasibility in the use of a FAAH inhibitor for the treatment of adults with Tourette syndrome.

Official Title
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FAAH Inhibitor Trial for Adults With Tourette Syndrome

Conditions
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Tourette Syndrome

Intervention / Treatment
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* Drug: PF-04457845
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult between 18-60 years of age 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: Comorbid bipolar disorder, psychotic disorder, substance use disorder, developmental disorder or intellectual disability (IQ<70). 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PF-04457845<br>PF-04457845 will be administered orally at 4mg daily for four weeks. | Drug: PF-04457845<br>* PF-04457845 will be administered orally at 4mg daily for four weeks.<br>* Other names: fatty acid amide hydrolase (FAAH) inhibitor;|
| Placebo Comparator: Placebo<br>Placebo (sugar pill) will be administered orally at 4mg daily for four weeks. | Drug: Placebo<br>* Placebo will be administered orally at 4mg daily for four weeks.<br>* Other names: Sugar Pill;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in Tic Severity | Yale Global Tic Severity Scale (Total Tic Score) | Evaluated each time subject seen over approximately 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of Premonitory Urges | Premonitory Urge for Tics Scale (PUTS) | Evaluated each time subject seen over approximately 12 Weeks | 
| Improvement in Obsessive Compulsive Disorder (OCD) Severity | Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) | Evaluated every two weeks over the course of approximately 12 weeks | 
| Self-Report of Tic Severity | Tourette Syndrome Symptom List (TSSL) | Evaluated each time subject seen over approximately 12 weeks | 
| Video-Tape Ratings of Tic Severity | Modified Rush Video Rating Scale | Evaluated every two weeks over the course of approximately 12 weeks | 
| ADHD Severity | Connors Adult Attention Deficit Hyperactivity Rating Scale | Evaluated every two weeks over the course of approximately 12 weeks | 
| Depression Severity | Hamilton Rating Scale for Depression | Evaluated every two weeks over the course of approximately 12 weeks | 
| Anxiety Severity | Hamilton Rating Scale for Anxiety | Evaluated every two weeks over the course of approximately 12 weeks | 
| Overall improvement | Clinical Global Improvement Scale | Evaluated each time subject seen over approximately 12 Weeks | 
| Number of Adverse Events | Adverse Events Rating Scale | Evaluated each time subject seen over approximately 12 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tourette Syndrome, FAAH-Inhibitor, Tics, Tic Disorders