The D1AMOND long-term safety extension study of ecopipam tablets in children, adolescents, and adults with Tourette’s Disorder
- Study HIC#:2000035226
- Last Updated:11/13/2024
The primary objective of this study is to evaluate the long-term safety and tolerability of ecopipam tablets in children, adolescents and adults with Tourette’s Disorder (TD) who are eligible following their participation in studies EBS-101-TD-301, EBS-101-OL-001, or PSY-302A.
The study will consist of 21 study visits incorporating into 4 periods: a screening period, a baseline period (when patient will start titration to the full dose), a treatment period (when patient will take the full dose of study drug), and a follow-up period. The maximum duration of participation in the study will be approximately 2 years.
Contact Us
For more information about this study, including how to volunteer, contact:
Angeli Landeros, MD
- Phone Number: 1-203-737-4809
Help Us Discover!
You can help our team find trials you might be eligible for by creating a volunteer profile in MyChart. To get started, create a volunteer profile, or contact helpusdiscover@yale.edu, or call +18779788343 for more information.
Eligibility Criteria
Patients who completed EBS-101-OL-001 or PSY302A studies may screen for eligibility. Patients who completed the EBS-101-TD-301 study may be eligible to enroll as follows:
- Those who completed all visits through Week 24 and days 7 and 14 safety follow-up.
- Those who met relapse criteria during the double-blind randomized withdrawal (R/WD) period after completing the early termination visit and Day 7 and Day 14 follow up visits may be eligible after the date of their projected Week 24 visit.
- Once relapse criteria has been met, all subjects currently in the study will be eligible after completing early termination visit, Day 7 and Day 14 follow up visits.
- All subjects will be titrated to a target dose of 1.8 mg/kg/day ecopipam (2 mg/kg/day dose of ecopipam HCl). Subjects will complete study visits monthly for the first 12months and every three months up to 24 months thereafter. Safety follow Up visits will be conducted 7 and 14 days after the last dose of study drug and a Follow Up phone call will be conducted 30 days after the last dose of study drug. Study visits may be completed in locations other than the clinic due to restrictions as a result of the ongoing COVID-19 pandemic or other qualifying event. Safety and efficacy assessments required at these visits may be available for remote administration.
