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Phase II

Ecopipam Tablets to Study Tourette Syndrome in Children and Adolescents - Open Label Extension (D1AMOND)

  • Study HIC#:2000027699
  • Last Updated:04/05/2022

This study is an international, multicenter, open-label, long term extension study evaluating the safety of ecopipam tablets for the treatment of children and adolescent subjects with Tourette Syndrome.

  • Age6 years - 18 years
  • GenderBoth
  • Start Date08/04/2021
  • End Date10/31/2022

Trial Purpose and Description

This is an international, multicenter, open-label, long term extension study evaluating the safety of ecopipam tablets for the treatment of pediatric subjects (aged ≥6 to ≤18 years at Baseline) with Tourette Syndrome. Subjects who completed the Phase 2b, randomized, double-blind, efficacy and safety study (EBS-101-CL-001) without major reportable protocol deviations, and who meet all the inclusion/exclusion criteria for this study will be eligible to participate in this study. All subjects who provide informed consent and participate in this study will be titrated to a target dose of 2 mg/kg/day. All participants rolling over from the Phase 2b double-blind efficacy and safety study will be tapered off of study medication to maintain the blind from that study. Subjects will complete study visits every month for 1 year. Follow Up visits will be conducted 7 and 14 days after the last dose of study medication and a Follow Up phone call will be conducted 30 days after the last dose of study medication.

Eligibility Criteria

Inclusion Criteria:

  • Subjects must have completed the EBS-101-CL-001 study through the Day 14 Follow Up Visit within the last 30 days (or longer with permission of the medical monitor) without a major reportable protocol deviation and must be someone the Investigator feels would benefit from continued participation.

Exclusion Criteria:

  • Certain mood or psychiatric disorders (i.e., dementia, bipolar disorder, schizophrenia, major depressive disorder).
  • Unstable medical illness or clinically significant lab abnormalities.
  • Risk of suicide.
  • Pregnant or lactating women.
  • Moderate to severe renal insufficiency.
  • Positive urine drug screen.
  • Certain medications that would lead to drug interactions.

Sub-Investigator

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