Ecopipam Treatment of Tourette Syndrome
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|