Clinical trial NCT02134080: FAAH Inhibitor Trial for Adults With Tourette Syndrome
Official title: FAAH Inhibitor Trial for Adults With Tourette Syndrome
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Tourette Syndrome
Keywords: Tourette Syndrome
FAAH-Inhibitor
Tics
Tic Disorders
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Tourette Association of America
First posted: 2014-05-08
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Improvement in Tic Severity
timeFrame: Evaluated each time subject seen over approximately 12 weeks
Secondary outcomes:
measure: Improvement of Premonitory Urges
timeFrame: Evaluated each time subject seen over approximately 12 Weeks
measure: Improvement in Obsessive Compulsive Disorder (OCD) Severity
timeFrame: Evaluated every two weeks over the course of approximately 12 weeks
measure: Self-Report of Tic Severity
timeFrame: Evaluated each time subject seen over approximately 12 weeks
measure: Video-Tape Ratings of Tic Severity
timeFrame: Evaluated every two weeks over the course of approximately 12 weeks
measure: ADHD Severity
timeFrame: Evaluated every two weeks over the course of approximately 12 weeks
measure: Depression Severity
timeFrame: Evaluated every two weeks over the course of approximately 12 weeks
measure: Anxiety Severity
timeFrame: Evaluated every two weeks over the course of approximately 12 weeks
measure: Overall improvement
timeFrame: Evaluated each time subject seen over approximately 12 Weeks
measure: Number of Adverse Events
timeFrame: Evaluated each time subject seen over approximately 12 Weeks
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Connecticut Mental Health Center
state: Connecticut
Study officials:
affiliation: Yale University
name: Michael H. Bloch, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: