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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
50 or 100 mg tablets given once per day for eight weeks
Johns Hopkins University
Baltimore, Maryland, United States
Atlantic Neuroscience Institute Overlook Hospital
Summit, New Jersey, United States
North Shore Hospital
Manhasset, New York, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Yale Global Tic Severity Score
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.
Time frame: 8 weeks
Adult Attention Deficit/Hyperactivity Disorder (ADHD) Self-report Symptom Checklist (ASRS)
This is a standard measure of ADHD severity that is typically used in these types of clinical trials.
Time frame: Every 7 days
Hamilton Depression Scale
This is a measure of feelings of depression that the patient might have.
Time frame: Every 7 days
Premonitory Urge for Tics Scale (PUTS-1)
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.
Time frame: Every 7 days
Clinician Global Impression - Improvement and Severity Scales (CGI)
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.
Time frame: End of trial
Safety Assessments
Patients will be evaluated for any adverse events, and they will have a variety of blood tests to examine if any changes occur.
Time frame: Every 7 days
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Columbia Scale for Suicide Risk
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.
Time frame: Every 7 days