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FAAH Inhibitor Trial for Adults With Tourette Syndrome

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ClinicalTrials.gov Identifier: NCT02134080
Recruitment Status : Terminated (no more funding available)
First Posted : May 8, 2014
Last Update Posted : October 29, 2018
Sponsor:
Collaborator:
Tourette Association of America
Information provided by (Responsible Party):
Yale University

Tracking Information
First Submitted Date  ICMJE May 6, 2014
First Posted Date  ICMJE May 8, 2014
Last Update Posted Date October 29, 2018
Study Start Date  ICMJE May 2014
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 6, 2014)
Improvement in Tic Severity [ Time Frame: Evaluated each time subject seen over approximately 12 weeks ]
Yale Global Tic Severity Scale (Total Tic Score)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 6, 2014)
  • Improvement of Premonitory Urges [ Time Frame: Evaluated each time subject seen over approximately 12 Weeks ]
    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 ]
    Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)
  • Self-Report of Tic Severity [ Time Frame: Evaluated each time subject seen over approximately 12 weeks ]
    Tourette Syndrome Symptom List (TSSL)
  • Video-Tape Ratings of Tic Severity [ Time Frame: Evaluated every two weeks over the course of approximately 12 weeks ]
    Modified Rush Video Rating Scale
  • ADHD Severity [ Time Frame: Evaluated every two weeks over the course of approximately 12 weeks ]
    Connors Adult Attention Deficit Hyperactivity Rating Scale
  • Depression Severity [ Time Frame: Evaluated every two weeks over the course of approximately 12 weeks ]
    Hamilton Rating Scale for Depression
  • Anxiety Severity [ Time Frame: Evaluated every two weeks over the course of approximately 12 weeks ]
    Hamilton Rating Scale for Anxiety
  • Overall improvement [ Time Frame: Evaluated each time subject seen over approximately 12 Weeks ]
    Clinical Global Improvement Scale
  • Number of Adverse Events [ Time Frame: Evaluated each time subject seen over approximately 12 Weeks ]
    Adverse Events Rating Scale
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE FAAH Inhibitor Trial for Adults With Tourette Syndrome
Official Title  ICMJE FAAH Inhibitor Trial for Adults With Tourette Syndrome
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Tourette Syndrome
Intervention  ICMJE
  • Drug: PF-04457845
    PF-04457845 will be administered orally at 4mg daily for four weeks.
    Other Name: fatty acid amide hydrolase (FAAH) inhibitor
  • Drug: Placebo
    Placebo will be administered orally at 4mg daily for four weeks.
    Other Name: Sugar Pill
Study Arms  ICMJE
  • Active Comparator: PF-04457845
    PF-04457845 will be administered orally at 4mg daily for four weeks.
    Intervention: Drug: PF-04457845
  • Placebo Comparator: Placebo
    Placebo (sugar pill) will be administered orally at 4mg daily for four weeks.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: October 25, 2018)
5
Original Estimated Enrollment  ICMJE
 (submitted: May 6, 2014)
10
Actual Study Completion Date  ICMJE March 2017
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02134080
Other Study ID Numbers  ICMJE 1403013669
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yale University
Study Sponsor  ICMJE Yale University
Collaborators  ICMJE Tourette Association of America
Investigators  ICMJE
Principal Investigator: Michael H. Bloch, MD, MS Yale University
PRS Account Yale University
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP