Tourette Syndrome
Conditions
Keywords
Tourette Syndrome, FAAH-Inhibitor, Tics, Tic Disorders
Brief summary
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.
Interventions
DRUGPF-04457845
PF-04457845 will be administered orally at 4mg daily for four weeks.
DRUGPlacebo
Placebo will be administered orally at 4mg daily for four weeks.
Sponsors
Tourette Association of America
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in Tic Severity | Evaluated each time subject seen over approximately 12 weeks | Yale Global Tic Severity Scale (Total Tic Score) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in Obsessive Compulsive Disorder (OCD) Severity | Evaluated every two weeks over the course of approximately 12 weeks | Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) |
| Self-Report of Tic Severity | Evaluated each time subject seen over approximately 12 weeks | Tourette Syndrome Symptom List (TSSL) |
| Video-Tape Ratings of Tic Severity | Evaluated every two weeks over the course of approximately 12 weeks | Modified Rush Video Rating Scale |
| ADHD Severity | Evaluated every two weeks over the course of approximately 12 weeks | Connors Adult Attention Deficit Hyperactivity Rating Scale |
| Improvement of Premonitory Urges | Evaluated each time subject seen over approximately 12 Weeks | Premonitory Urge for Tics Scale (PUTS) |
| Anxiety Severity | Evaluated every two weeks over the course of approximately 12 weeks | Hamilton Rating Scale for Anxiety |
| Overall improvement | Evaluated each time subject seen over approximately 12 Weeks | Clinical Global Improvement Scale |
| Number of Adverse Events | Evaluated each time subject seen over approximately 12 Weeks | Adverse Events Rating Scale |
| Depression Severity | Evaluated every two weeks over the course of approximately 12 weeks | Hamilton Rating Scale for Depression |
Countries
United States
Outcome results
None listed