Not provided
Not provided
Not provided
Not provided
Not provided
no more funding available
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Tourette Association of America | OTHER |
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-04457845 | Active Comparator | PF-04457845 will be administered orally at 4mg daily for four weeks. |
|
| Placebo | Placebo Comparator | Placebo (sugar pill) will be administered orally at 4mg daily for four weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-04457845 | Drug | PF-04457845 will be administered orally at 4mg daily for four weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in Tic Severity | Yale Global Tic Severity Scale (Total Tic Score) | Evaluated each time subject seen over approximately 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of Premonitory Urges | Premonitory Urge for Tics Scale (PUTS) | Evaluated each time subject seen over approximately 12 Weeks |
| Improvement in Obsessive Compulsive Disorder (OCD) Severity |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Michael H. Bloch, MD, MS | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Connecticut Mental Health Center | New Haven | Connecticut | 06519 | United States |
Not provided
| ID | Term |
|---|---|
| D005879 | Tourette Syndrome |
| D020323 | Tics |
| D013981 | Tic Disorders |
| ID | Term |
|---|---|
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C560620 | N-pyridazin-3-yl-4-(3-((5-(trifluoromethyl)pyridin-2-yl)oxy)benzylidene)piperidine-1-carboxamide |
| C102018 | fatty-acid amide hydrolase |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D002241 | Carbohydrates |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Placebo will be administered orally at 4mg daily for four weeks. |
|
|
Yale-Brown Obsessive-Compulsive Scale (Y-BOCS)
| Evaluated every two weeks over the course of approximately 12 weeks |
| Self-Report of Tic Severity | Tourette Syndrome Symptom List (TSSL) | Evaluated each time subject seen over approximately 12 weeks |
| Video-Tape Ratings of Tic Severity | Modified Rush Video Rating Scale | Evaluated every two weeks over the course of approximately 12 weeks |
| ADHD Severity | Connors Adult Attention Deficit Hyperactivity Rating Scale | Evaluated every two weeks over the course of approximately 12 weeks |
| Depression Severity | Hamilton Rating Scale for Depression | Evaluated every two weeks over the course of approximately 12 weeks |
| Anxiety Severity | Hamilton Rating Scale for Anxiety | Evaluated every two weeks over the course of approximately 12 weeks |
| Overall improvement | Clinical Global Improvement Scale | Evaluated each time subject seen over approximately 12 Weeks |
| Number of Adverse Events | Adverse Events Rating Scale | Evaluated each time subject seen over approximately 12 Weeks |
| D009069 | Movement Disorders |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |