FAAH Inhibitor Trial for Adults With Tourette Syndrome

Tourette Syndrome Clinical Trial

Official title:

FAAH Inhibitor Trial for Adults With Tourette Syndrome

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02134080
• Other study ID #: 1403013669
• Status: Terminated
• Phase: Phase 1
• Start date: May 2014
• Est. completion date: March 2017

Study information

• Verified date: October 2018
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Syndrome
• Tourette Syndrome

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	Connecticut Mental Health Center	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	Tourette Association of America

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in Tic Severity	Yale Global Tic Severity Scale (Total Tic Score)	Evaluated each time subject seen over approximately 12 weeks
Secondary	Improvement of Premonitory Urges	Premonitory Urge for Tics Scale (PUTS)	Evaluated each time subject seen over approximately 12 Weeks
Secondary	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
Secondary	Self-Report of Tic Severity	Tourette Syndrome Symptom List (TSSL)	Evaluated each time subject seen over approximately 12 weeks
Secondary	Video-Tape Ratings of Tic Severity	Modified Rush Video Rating Scale	Evaluated every two weeks over the course of approximately 12 weeks
Secondary	ADHD Severity	Connors Adult Attention Deficit Hyperactivity Rating Scale	Evaluated every two weeks over the course of approximately 12 weeks
Secondary	Depression Severity	Hamilton Rating Scale for Depression	Evaluated every two weeks over the course of approximately 12 weeks
Secondary	Anxiety Severity	Hamilton Rating Scale for Anxiety	Evaluated every two weeks over the course of approximately 12 weeks
Secondary	Overall improvement	Clinical Global Improvement Scale	Evaluated each time subject seen over approximately 12 Weeks
Secondary	Number of Adverse Events	Adverse Events Rating Scale	Evaluated each time subject seen over approximately 12 Weeks