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

  • STATUS
    Recruiting
  • End date
    Nov 1, 2022
  • participants needed
    150
  • sponsor
    Emalex Biosciences Inc.
Updated on 1 December 2021

Summary

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.

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.

Details
Condition Tourette Syndrome in Children, Tourette Syndrome in Adolescence
Treatment Ecopipam
Clinical Study IdentifierNCT04114539
SponsorEmalex Biosciences Inc.
Last Modified on1 December 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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