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FAAH Inhibitor Trial for Adults With Tourette Syndrome

Primary Purpose

Tourette Syndrome

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

PF-04457845

Placebo

About this trial

This is an interventional treatment trial for Tourette Syndrome focused on measuring Tourette Syndrome, FAAH-Inhibitor, Tics, Tic Disorders

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Connecticut Mental Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

PF-04457845

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Improvement in Tic Severity

Yale Global Tic Severity Scale (Total Tic Score)

Secondary Outcome Measures

Improvement of Premonitory Urges

Premonitory Urge for Tics Scale (PUTS)

Improvement in Obsessive Compulsive Disorder (OCD) Severity

Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)

Self-Report of Tic Severity

Tourette Syndrome Symptom List (TSSL)

Video-Tape Ratings of Tic Severity

Modified Rush Video Rating Scale

ADHD Severity

Connors Adult Attention Deficit Hyperactivity Rating Scale

Depression Severity

Hamilton Rating Scale for Depression

Anxiety Severity

Hamilton Rating Scale for Anxiety

Overall improvement

Clinical Global Improvement Scale

Number of Adverse Events

Adverse Events Rating Scale

Full Information

NCT ID

NCT02134080

First Posted

May 6, 2014

Last Updated

October 25, 2018

Sponsor

Yale University

Collaborators

Tourette Association of America

1. Study Identification

Unique Protocol Identification Number

NCT02134080

Brief Title

FAAH Inhibitor Trial for Adults With Tourette Syndrome

Official Title

FAAH Inhibitor Trial for Adults With Tourette Syndrome

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Terminated

Why Stopped

no more funding available

Study Start Date

May 2014 (undefined)

Primary Completion Date

March 2017 (Actual)

Study Completion Date

March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yale University

Collaborators

Tourette Association of America

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tourette Syndrome

Keywords

Tourette Syndrome, FAAH-Inhibitor, Tics, Tic Disorders

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

5 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PF-04457845

Arm Type

Active Comparator

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

PF-04457845

Other Intervention Name(s)

fatty acid amide hydrolase (FAAH) inhibitor

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Sugar Pill

Intervention Description

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

Primary Outcome Measure Information:

Title

Improvement in Tic Severity

Description

Yale Global Tic Severity Scale (Total Tic Score)

Time Frame

Evaluated each time subject seen over approximately 12 weeks

Secondary Outcome Measure Information:

Title

Improvement of Premonitory Urges

Description

Premonitory Urge for Tics Scale (PUTS)

Time Frame

Evaluated each time subject seen over approximately 12 Weeks

Title

Improvement in Obsessive Compulsive Disorder (OCD) Severity

Description

Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)

Time Frame

Evaluated every two weeks over the course of approximately 12 weeks

Title

Self-Report of Tic Severity

Description

Tourette Syndrome Symptom List (TSSL)

Time Frame

Evaluated each time subject seen over approximately 12 weeks

Title

Video-Tape Ratings of Tic Severity

Description

Modified Rush Video Rating Scale

Time Frame

Evaluated every two weeks over the course of approximately 12 weeks

Title

ADHD Severity

Description

Connors Adult Attention Deficit Hyperactivity Rating Scale

Time Frame

Evaluated every two weeks over the course of approximately 12 weeks

Title

Depression Severity

Description

Hamilton Rating Scale for Depression

Time Frame

Evaluated every two weeks over the course of approximately 12 weeks

Title

Anxiety Severity

Description

Hamilton Rating Scale for Anxiety

Time Frame

Evaluated every two weeks over the course of approximately 12 weeks

Title

Overall improvement

Description

Clinical Global Improvement Scale

Time Frame

Evaluated each time subject seen over approximately 12 Weeks

Title

Number of Adverse Events

Description

Adverse Events Rating Scale

Time Frame

Evaluated each time subject seen over approximately 12 Weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael H. Bloch, MD, MS

Organizational Affiliation

Yale University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Connecticut Mental Health Center

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06519

Country

United States

12. IPD Sharing Statement

Learn more about this trial

FAAH Inhibitor Trial for Adults With Tourette Syndrome

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