Tourette SyndromePhase 1NCT02134080
FAAH Inhibitor Trial for Adults With Tourette Syndrome
A Phase 1 study testing PF-04457845 in people with Tourette Syndrome, run by Yale University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Tourette Syndrome
- What is being tested?
- PF-04457845
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Mar 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Connecticut Mental Health Center
New Haven, Connecticut, 06519
About this study
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.
- Conditions
- Tourette Syndrome
- Being tested
- PF-04457845, Placebo
- Keywords
- Tourette Syndrome, FAAH-Inhibitor, Tics, Tic Disorders
- Medical subject headings
- Tourette Syndrome, Tics, Tic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PF-04457845Drug
Also called fatty acid amide hydrolase (FAAH) inhibitor
PF-04457845 will be administered orally at 4mg daily for four weeks.
PlaceboDrug
Also called Sugar Pill
Placebo will be administered orally at 4mg daily for four weeks.
| Study group | Role | What they receive |
|---|---|---|
| PF-04457845 | Active comparator | PF-04457845 will be administered orally at 4mg daily for four weeks. Receives: Drug: PF-04457845 |
| Placebo | Placebo comparator | Placebo (sugar pill) will be administered orally at 4mg daily for four weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Tic Severity
Yale Global Tic Severity Scale (Total Tic Score)
Measured: Evaluated each time subject seen over approximately 12 weeks
Secondary outcomes (9)
Improvement of Premonitory Urges
Premonitory Urge for Tics Scale (PUTS)
Measured: Evaluated each time subject seen over approximately 12 Weeks
Improvement in Obsessive Compulsive Disorder (OCD) Severity
Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)
Measured: Evaluated every two weeks over the course of approximately 12 weeks
Self-Report of Tic Severity
Tourette Syndrome Symptom List (TSSL)
Measured: Evaluated each time subject seen over approximately 12 weeks
Video-Tape Ratings of Tic Severity
Modified Rush Video Rating Scale
Measured: Evaluated every two weeks over the course of approximately 12 weeks
ADHD Severity
Connors Adult Attention Deficit Hyperactivity Rating Scale
Measured: Evaluated every two weeks over the course of approximately 12 weeks
Depression Severity
Hamilton Rating Scale for Depression
Measured: Evaluated every two weeks over the course of approximately 12 weeks
Anxiety Severity
Hamilton Rating Scale for Anxiety
Measured: Evaluated every two weeks over the course of approximately 12 weeks
Overall improvement
Clinical Global Improvement Scale
Measured: Evaluated each time subject seen over approximately 12 Weeks
Number of Adverse Events
Adverse Events Rating Scale
Measured: Evaluated each time subject seen over approximately 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2014 (estimated)
- Study startMay 2014
- Primary completionMar 2017
- Study completionMar 2017
Why it stopped: no more funding available
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tourette SyndromeStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Tourette Association of America
- Responsible party
- Sponsor
- Investigators
- Michael H. Bloch, MD, MS, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02134080
- Sponsor's protocol ID
- 1403013669
- Status last verified
- Oct 2018
- First submitted
- 6 May 2014
- Last updated
- 29 Oct 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FAAH Inhibitor Trial for Adults With Tourette Syndrome
- ClinicalTrials.gov ID
- NCT02134080
- Acronym / sponsor ID
- 1403013669
- Conditions
- Tourette Syndrome
- Keywords
- Tourette Syndrome, FAAH-Inhibitor, Tics, Tic Disorders
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: no more funding available
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Tourette Association of America
- Study start
- May 2014
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 8 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PF-04457845 | Active comparator | Drug: PF-04457845PF-04457845 will be administered orally at 4mg daily for four weeks. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo (sugar pill) will be administered orally at 4mg daily for four weeks. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PF-04457845Also: fatty acid amide hydrolase (FAAH) inhibitorPF-04457845 will be administered orally at 4mg daily for four weeks. | Drug | PF-04457845 |
| PlaceboAlso: Sugar PillPlacebo will be administered orally at 4mg daily for four weeks. | Drug | Placebo |
Primary outcome
Improvement in Tic Severity
Time frame: Evaluated each time subject seen over approximately 12 weeks
Yale Global Tic Severity Scale (Total Tic Score)
9 secondary outcomes
Improvement of Premonitory Urges
Time frame: Evaluated each time subject seen over approximately 12 Weeks
Improvement in Obsessive Compulsive Disorder (OCD) Severity
Time frame: Evaluated every two weeks over the course of approximately 12 weeks
Self-Report of Tic Severity
Time frame: Evaluated each time subject seen over approximately 12 weeks
Video-Tape Ratings of Tic Severity
Time frame: Evaluated every two weeks over the course of approximately 12 weeks
ADHD Severity
Time frame: Evaluated every two weeks over the course of approximately 12 weeks
Depression Severity
Time frame: Evaluated every two weeks over the course of approximately 12 weeks
Anxiety Severity
Time frame: Evaluated every two weeks over the course of approximately 12 weeks
Overall improvement
Time frame: Evaluated each time subject seen over approximately 12 Weeks
Number of Adverse Events
Time frame: Evaluated each time subject seen over approximately 12 Weeks
Results and safety
The study was stopped early (reason given: no more funding available). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael H. Bloch, MD, MS principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PF-04457845 in people with Tourette Syndrome, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: no more funding available). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in Tic Severity (time frame: Evaluated each time subject seen over approximately 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2018.