Tourette’s Study for Children, Teens and Adults
$50 per completed visit
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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