Ecopipam Tablets to Study Tourette's Disorder in Children, Adolescents and Adults

Last updated: November 12, 2025
Sponsor: Emalex Biosciences Inc.
Overall Status: Completed

Phase

3

Condition

Tourette's Syndrome

Tic Disorders

Autism

Treatment

Ecopipam Hydrochloride

Clinical Study ID

NCT05615220
EBS-101-TD-301
2022-001961-11
2023-503494-38-00
  • Ages > 6
  • All Genders

Study 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 a double-blind, placebo-controlled, randomized withdrawal period.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • ≥ 6 years of age

  • ≥ 18 kg (~ 40 lbs.)

  • TD diagnosis and both motor and vocal tics that cause impairment with normalroutines

  • 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 14days prior to Baseline.

  • Effective contraception during the study and 30 days after last study dose forsexually active subjects

Exclusion

Exclusion Criteria:

  • Previous exposure to ecopipam

  • 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

  • Hepatic insufficiency

  • Positive urine drug screen

  • Unstable doses for drugs to treat anxiety, depression, Attention DeficitHyperactivity Disorder

  • Certain medications that would lead to drug interactions

  • Recent behavioral therapy

Study Design

Total Participants: 216
Treatment Group(s): 1
Primary Treatment: Ecopipam Hydrochloride
Phase: 3
Study Start date:
January 31, 2023
Estimated Completion Date:
February 04, 2025

Study 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.

Connect with a study center

  • Center Spectar-Plovdiv

    Plovdiv 728193, Bulgaria 4004
    Bulgaria

    Site Not Available

  • ASMP-IP- d-r Kayryakova

    Sofia, Sofia City 1360
    Bulgaria

    Site Not Available

  • ASMP-IP- d-r Kayryakova

    Sofia 727011, Sofia-Grad 731061 1360
    Bulgaria

    Site Not Available

  • Center Spectar-Plovdiv

    Plovdiv, 4004
    Bulgaria

    Site Not Available

  • Kalimat Medical Center_Sofia

    Sofia, 1680
    Bulgaria

    Site Not Available

  • Kalimat Medical Center_Sofia

    Sofia 727011, 1680
    Bulgaria

    Site Not Available

  • DCC Mladost-M Varna

    Varna, 9020
    Bulgaria

    Site Not Available

  • DCC Mladost-M Varna

    Varna 726050, 9020
    Bulgaria

    Site Not Available

  • University of Calgary

    Calgary, Alberta T2N 4Z6
    Canada

    Site Not Available

  • University of Calgary

    Calgary 5913490, Alberta 5883102 T2N 4Z6
    Canada

    Site Not Available

  • The Kids Clinic Inc

    Ajax, Ontario L1Z 0M1
    Canada

    Site Not Available

  • Center for Pediatric Excellence

    Ottawa, Ontario K2G 1W2
    Canada

    Site Not Available

  • The Kids Clinic Inc

    Ajax 5882873, Ontario 6093943 L1Z 0M1
    Canada

    Site Not Available

  • Borne og Ungeafdelingen

    Herlev, 02730
    Denmark

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  • Borne og Ungeafdelingen

    Herlev 2620431, 02730
    Denmark

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  • CHU Grenoble Alpes - Hopital Couple Enfant

    Grenoble, 38000
    France

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  • CHU Grenoble Alpes - Hopital Couple Enfant

    Grenoble 3014728, 38000
    France

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  • Hôpital Fondation Rothschild

    Paris, 75019
    France

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  • Hôpital Fondation Rothschild

    Paris 2988507, 75019
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    Strasbourg, 67098
    France

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    Strasbourg 2973783, 67098
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    Munich 2867714, Bavaria 2951839 80336
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    Muenchen, Bayern 80336
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    Hanover 2910831, Lower Saxony 2862926 30625
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    Hannover, Niedersachsen 30625
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    Mannheim, 68159
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    Szeged, Csongrád 6725
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    Szeged 715429, Csongrád megye 721589 6725
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  • Texas Children's Hospital (TCH)

    Houston 4699066, Texas 4736286 77030
    United States

    Site Not Available

  • The University of Texas Health Science Center at Houston

    Houston 4699066, Texas 4736286 77030
    United States

    Site Not Available

  • Perceptive Pharma Research (PPR)

    Richmond 4722684, Texas 4736286 77407
    United States

    Site Not Available

  • Road Runner Research Ltd.

    San Antonio 4726206, Texas 4736286 78249-3539
    United States

    Site Not Available

  • Cedar Clinical Research

    Draper, Utah 84020
    United States

    Site Not Available

  • Cedar Clinical Research

    Draper 5774001, Utah 5549030 84020
    United States

    Site Not Available

  • Core Clinical Research

    Everett, Washington 98201
    United States

    Site Not Available

  • Core Clinical Research

    Everett 5793933, Washington 5815135 98201
    United States

    Site Not Available

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