NCT02134080

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started May 2014

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

May 6, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 8, 2014

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

October 29, 2018

Status Verified

October 1, 2018

Enrollment Period

2.8 years

First QC Date

May 6, 2014

Last Update Submit

October 25, 2018

Conditions

Tourette Syndrome

Keywords

Tourette SyndromeFAAH-InhibitorTicsTic Disorders

Outcome Measures

Primary Outcomes (1)

  • Improvement in Tic Severity

    Yale Global Tic Severity Scale (Total Tic Score)

    Evaluated each time subject seen over approximately 12 weeks

Secondary Outcomes (9)

  • Improvement of Premonitory Urges

    Evaluated each time subject seen over approximately 12 Weeks

  • Improvement in Obsessive Compulsive Disorder (OCD) Severity

    Evaluated every two weeks over the course of approximately 12 weeks

  • Self-Report of Tic Severity

    Evaluated each time subject seen over approximately 12 weeks

  • Video-Tape Ratings of Tic Severity

    Evaluated every two weeks over the course of approximately 12 weeks

  • ADHD Severity

    Evaluated every two weeks over the course of approximately 12 weeks

  • +4 more secondary outcomes

Study Arms (2)

PF-04457845

ACTIVE COMPARATOR

PF-04457845 will be administered orally at 4mg daily for four weeks.

Drug: PF-04457845

Placebo

PLACEBO COMPARATOR

Placebo (sugar pill) will be administered orally at 4mg daily for four weeks.

Drug: Placebo

Interventions

PF-04457845DRUG

PF-04457845 will be administered orally at 4mg daily for four weeks.

Also known as: fatty acid amide hydrolase (FAAH) inhibitor
PF-04457845
PlaceboDRUG

Placebo will be administered orally at 4mg daily for four weeks.

Also known as: Sugar Pill
Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Connecticut Mental Health Center

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Tourette SyndromeTicsTic Disorders

Interventions

N-pyridazin-3-yl-4-(3-((5-(trifluoromethyl)pyridin-2-yl)oxy)benzylidene)piperidine-1-carboxamidefatty-acid amide hydrolaseSugars

Condition Hierarchy (Ancestors)

Basal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNeurodevelopmental DisordersMental DisordersDyskinesiasNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Carbohydrates

Study Officials

  • Michael H. Bloch, MD, MS

    Yale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2014

First Posted

May 8, 2014

Study Start

May 1, 2014

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

October 29, 2018

Record last verified: 2018-10

Locations

US(1)