FAAH Inhibitor Trial for Adults With Tourette Syndrome

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Yale University
Sponsor:
Collaborator:
Tourette Syndrome Association
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT02134080
First received: May 6, 2014
Last updated: July 29, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Tourette Syndrome
Drug: PF-04457845
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: FAAH Inhibitor Trial for Adults With Tourette Syndrome

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Improvement in Tic Severity [ Time Frame: Evaluated each time subject seen over approximately 12 weeks ] [ Designated as safety issue: No ]
    Yale Global Tic Severity Scale (Total Tic Score)


Secondary Outcome Measures:
  • Improvement of Premonitory Urges [ Time Frame: Evaluated each time subject seen over approximately 12 Weeks ] [ Designated as safety issue: No ]
    Premonitory Urge for Tics Scale (PUTS)

  • Improvement in Obsessive Compulsive Disorder (OCD) Severity [ Time Frame: Evaluated every two weeks over the course of approximately 12 weeks ] [ Designated as safety issue: No ]
    Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)

  • Self-Report of Tic Severity [ Time Frame: Evaluated each time subject seen over approximately 12 weeks ] [ Designated as safety issue: No ]
    Tourette Syndrome Symptom List (TSSL)

  • Video-Tape Ratings of Tic Severity [ Time Frame: Evaluated every two weeks over the course of approximately 12 weeks ] [ Designated as safety issue: No ]
    Modified Rush Video Rating Scale

  • ADHD Severity [ Time Frame: Evaluated every two weeks over the course of approximately 12 weeks ] [ Designated as safety issue: No ]
    Connors Adult Attention Deficit Hyperactivity Rating Scale

  • Depression Severity [ Time Frame: Evaluated every two weeks over the course of approximately 12 weeks ] [ Designated as safety issue: No ]
    Hamilton Rating Scale for Depression

  • Anxiety Severity [ Time Frame: Evaluated every two weeks over the course of approximately 12 weeks ] [ Designated as safety issue: No ]
    Hamilton Rating Scale for Anxiety

  • Overall improvement [ Time Frame: Evaluated each time subject seen over approximately 12 Weeks ] [ Designated as safety issue: No ]
    Clinical Global Improvement Scale

  • Number of Adverse Events [ Time Frame: Evaluated each time subject seen over approximately 12 Weeks ] [ Designated as safety issue: Yes ]
    Adverse Events Rating Scale


Estimated Enrollment: 10
Study Start Date: May 2014
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Sugar Pill

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02134080

Contacts
Contact: Catherine Coughlin, BS 203-737-4809 catherine.coughlin@yale.edu

Locations
United States, Connecticut
Connecticut Mental Health Center Recruiting
New Haven, Connecticut, United States, 06519
Contact: Catherine G. Coughlin, BS    203-737-4809    catherine.coughlin@yale.edu   
Principal Investigator: Michael H. Bloch, MD, MS         
Sponsors and Collaborators
Yale University
Tourette Syndrome Association
Investigators
Principal Investigator: Michael H. Bloch, MD, MS Yale University
  More Information

No publications provided

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02134080     History of Changes
Other Study ID Numbers: 1403013669
Study First Received: May 6, 2014
Last Updated: July 29, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Yale University:
Tourette Syndrome
FAAH-Inhibitor
Tics
Tic Disorders

Additional relevant MeSH terms:
Syndrome
Tourette Syndrome
Disease
Pathologic Processes
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tic Disorders
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on September 18, 2014