FAAH Inhibitor Trial for Adults With Tourette Syndrome

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.

Study Overview

• Status: Terminated
• Conditions: Tourette Syndrome
• Intervention / Treatment: Drug: PF-04457845; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06519
      • Connecticut Mental Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: Tourette Association of America
• Investigators: Principal Investigator: Michael H. Bloch, MD, MS, Yale University

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: May 6, 2014
• First Submitted That Met QC Criteria: May 6, 2014
• First Posted (Estimate): May 8, 2014

Study Record Updates

• Last Update Posted (Actual): October 29, 2018
• Last Update Submitted That Met QC Criteria: October 25, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Tourette Syndrome; Tic Disorders; Tics; FAAH-Inhibitor
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Disease; Genetic Diseases, Inborn; Basal Ganglia Diseases; Movement Disorders; Neurodegenerative Diseases; Heredodegenerative Disorders, Nervous System; Neurodevelopmental Disorders; Tic Disorders; Syndrome; Tourette Syndrome
• Other Study ID Numbers: 1403013669