Ecopipam Treatment of Tourette Syndrome
|ClinicalTrials.gov Identifier: NCT01244633|
Recruitment Status : Completed
First Posted : November 19, 2010
Results First Posted : September 29, 2015
Last Update Posted : September 29, 2015
|Condition or disease||Intervention/treatment||Phase|
|Tourette's Syndrome||Drug: Ecopipam||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Ecopipam Treatment of Tourette Syndrome|
|Study Start Date :||October 2010|
|Actual Primary Completion Date :||July 2012|
|Actual Study Completion Date :||July 2013|
50 or 100 mg tablets given once per day for eight weeks
- Yale Global Tic Severity Score [ Time Frame: 8 weeks ]The Yale Global Tic Severity Score is a composite of subject reported severity of motor (range 0-25) and vocal (range 0-25) tics , as well as an impairment score (range 0-50). The outcome we are using is the Total Tic Severity score which is the sum of the motor and vocal tic severity scores (range 0-50). The higher the score on this scale, the more severe the symptoms. A positive drug effect is associated with a decrease from baseline.
- Adult Attention Deficit/Hyperactivity Disorder (ADHD) Self-report Symptom Checklist (ASRS) [ Time Frame: Every 7 days ]This is a standard measure of ADHD severity that is typically used in these types of clinical trials.
- Hamilton Depression Scale [ Time Frame: Every 7 days ]This is a measure of feelings of depression that the patient might have.
- Premonitory Urge for Tics Scale (PUTS-1) [ Time Frame: Every 7 days ]This is a measure of the tic behavior that is seen in Tourette's patients, and it is typically used in these types of trials.
- Clinician Global Impression - Improvement and Severity Scales (CGI) [ Time Frame: End of trial ]This is a measure of how the treating physician perceives the effectiveness of a drug treatment, and it is typically used in these types of clinical trials.
- Safety Assessments [ Time Frame: Every 7 days ]Patients will be evaluated for any adverse events, and they will have a variety of blood tests to examine if any changes occur.
- Columbia Scale for Suicide Risk [ Time Frame: Every 7 days ]This test monitors whether the patient has any feelings of committing self-harm. It is mandated by the FDA to include this scale in all clinical trials of new central nervous system drugs.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01244633
|United States, Maryland|
|Johns Hopkins University|
|Baltimore, Maryland, United States, 21287|
|United States, New Jersey|
|Atlantic Neuroscience Institute Overlook Hospital|
|Summit, New Jersey, United States, 07092|
|United States, New York|
|North Shore Hospital|
|Manhasset, New York, United States, 11030|
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center|
|Cincinnati, Ohio, United States, 45229|
|Principal Investigator:||Donald Gilbert, MD||Children's Hospital Medical Center, Cincinnati|