FAAH Inhibitor Trial for Adults With Tourette Syndrome

Yale University

Status and phase

Terminated

Phase 1

Conditions

Tourette Syndrome

Treatments

Drug: PF-04457845

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT02134080

1403013669

Details and patient eligibility

About

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.

Enrollment

5 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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