Ecopipam Treatment of Tourette Syndrome
Tourette's Syndrome is a neurological disease characterized by verbal and motor tics. The currently available drug treatments are considered to be inadequate. This clinical trial is designed to test if ecopipam is effective for the treatment of Tourette's Syndrome in adults.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Ecopipam Treatment of Tourette Syndrome|
- Yale Global Tic Severity Score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]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.
|Study Start Date:||October 2010|
|Study Completion Date:||July 2013|
|Primary Completion Date:||July 2012 (Final data collection date for primary outcome measure)|
50 or 100 mg tablets given once per day for eight weeks
Tourette's Syndrome is a neurological disease characterized by verbal and motor tics. Although its causes are unknown, many researchers believe that changes in brain chemicals (called neurotransmitters) are critically involved. One of these neurotransmitters is called dopamine, and it exerts its actions through its receptors (called D1-type or D2-type). It has been suggested that the symptoms of Tourette's Syndrome are due to an overactivity at the D1-type receptor. Ecopipam is a selective antagonist of the D1-type receptors. The present clinical trial is designed to test if ecopipam is able to relieve the symptoms of the disease in adults patients with Tourette's Syndrome. Eligible patients will be treated for eight weeks.
Please refer to this study by its ClinicalTrials.gov identifier: 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|