Summary
This Phase 3 multicenter study evaluates the maintenance of efficacy, safety and tolerability of ecopipam tablets in children, adolescents and adults in the treatment of Tourette's Disorder (TD). The study includes an open-label period followed by double-blind, placebo-controlled, randomized withdrawal period.
Conditions
Tourette Disorder
Recruitment Status
Recruiting
Detailed Description
Following a 28-day Screening period and Baseline visit, eligible subjects will be enrolled into the open-label Stabilization period comprised of a 4-week Titration phase to achieve a target steady-state dose of 1.8 mg/kg/day ecopipam (2 mg/kg/day ecopipam HCl) followed by an 8-week open-label Maintenance phase. Responders to ecopipam will be randomized to ecopipam 1.8 mg/kg/day (2 mg/kg/day ecopipam HCl) or placebo in a 1:1 fashion and enter the double-blind Randomized-Withdrawal (R/WD) period at Week 12. During the 12-week R/WD period, any subject meeting Relapse criteria will be withdrawn from blinded study medication and complete end of study assessments including safety follow up visits.
Eligibility Criteria
Inclusion Criteria:
≥ 6 years of age
≥ 18 kg (~ 40 lbs.)
TD diagnosis and both motor and vocal tics that cause impairment with normal routines
Minimum score of 20 on the YGTSS-R Total Tic Score
May not be taking any medications used to treat motor or vocal tics for at least 14 days prior to Baseline.
Effective contraception during the study and 30 days after last study dose for sexually active subjects
Exclusion Criteria:
Previous exposure to ecopipam
Certain mood or psychiatric disorders (i.e., dementia, bipolar disorder, schizophrenia, major depressive disorder)
Unstable unstable medical illness or clinically significant lab abnormalities
Risk of suicide
Pregnant or lactating women
Moderate to severe renal insufficiency
Hepatic insufficiency
Positive urine drug screen
Unstable doses for drugs to treat anxiety, depression, Attention Deficit Hyperactivity Disorder
Certain medications that would lead to drug interactions
Recent behavioral therapy
Intervention
Intervention Type
Intervention Name
Drug
Ecopipam Hydrochloride
Phase
Phase 3
Gender
All
Min Age
6 Years
Max Age
N/A
Download Date
April 18, 2024
Principal Investigator
This field has been modified from ClinicalTrials.gov to show a contact specific to Boston Children's.
Primary Contact Information
leah.cheng@childrens.harvard.edu
This field has been modified from ClinicalTrials.gov to show a contact specific to Boston Children's.
For more information on this trial, visit clinicaltrials.gov.
Contact
For more information and to contact the study team: