Tourette’s Study for Children, Teens and Adults

Tourette's Study

Study Specific Details:

Ecopipam vs. Placebo. This is a double-blind, placebo-controlled study to evaluate the safety and efficacy of Ecopipam in children, teens and adults.
Psychological therapies or deep brain stimulation are okay as long as they have been stable for 10 weeks or longer prior to baseline.
Fasting at screening is optional.
24-week treatment period.

Must be 6 years or older to participate.
Must weigh at least 39.6lbs
Must be able to swallow a tablet.
Tourette's Disorder must be primary.
Must exhibit both motor and vocal tics that cause impairment with normal routines.
Medication for the treatment of motor or vocal tics will have a 14-day washout period prior to baseline.

Current PHQ-9 score of 10 or higher.
Must not have had an onset of a major depressive episode in the past 6 months.
Lifetime history of dementia, bipolar disorder, schizophrenia, or any psychotic disorder.
Previous treatment of Ecopipam or oral antipsychotics within 4 weeks of screening, depot antipsychotics within 3 months of screening.
Antidepressants, antipsychotics and anti-ADHD medications.
Medications that may have unfavorable interactions with study medication: P-gp, CYP2D6 inhibitors to include fluoxetine or APTP1B1 substrates w/ narrow therapeutic window, dopamine antagonists or agonists, MAOI's and St. John's Wart.
Subject with any unstable mood disorder.
Current or recent within the past 3 months of substance use disorder (except for nicotine).
Siblings or family members of any current subject participating in the study.
History of seizures (excluding febrile seizures that occurred >2 years prior to screening).
History of a suicide attempt.
Huntington's disease, Parkinson's disease, Wilson's disease, stroke and Restless legs Syndrome.

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