Ecopipam Tablets to Study Tourette's Disorder in Children, Adolescents and Adults (D1AMOND)

May 20, 2026 updated by: Emalex Biosciences Inc.

A Multicenter, Double-Blind, Placebo-Controlled, Randomized Withdrawal Study to Evaluate the Safety and Maintenance of Efficacy of Ecopipam in Children, Adolescents and Adults With Tourette's Disorder

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 During the 12-week R/WD period, any subject meeting Relapse criteria will be withdrawn from blinded study medication and complete end of study assessments including safety follow up visits.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
216

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Bulgaria
      • Sofia, Bulgaria, 1680
        • Kalimat Medical Center_Sofia
      • Varna, Bulgaria, 9020
        • DCC Mladost-M Varna
    • Bulgaria
      • Plovdiv, Bulgaria, Bulgaria, 4004
        • Center Spectar-Plovdiv
    • Sofia-Grad
      • Sofia, Sofia-Grad, Bulgaria, 1360
        • ASMP-IP- d-r Kayryakova
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • University Of Calgary
    • Ontario
      • Ajax, Ontario, Canada, L1Z 0M1
        • The Kids Clinic Inc
  • Denmark
      • Herlev, Denmark, 02730
        • Borne og Ungeafdelingen
  • France
      • Grenoble, France, 38000
        • CHU Grenoble Alpes - Hopital Couple Enfant
      • Paris, France, 75019
        • Hôpital Fondation Rothschild
      • Strasbourg, France, 67098
        • CHU Strasbourg-Hopital de Hautepierre
  • Germany
      • Mannheim, Germany, 68159
        • Zentralinstitut fuer Seelische Gesundheit, Mannheim
    • Bavaria
      • Munich, Bavaria, Germany, 80336
        • Psychiatric Clinic of Ludwig Maximilians Universitaet Muenchen
    • Lower Saxony
      • Hanover, Lower Saxony, Germany, 30625
        • Department of Psychiatry, Socialpsychiatry and Psychotherapy, Hannover Medical School
  • Hungary
      • Budapest, Hungary, 1021
        • Vadaskert Gyermek- es Ifjusagpszichiatriai Korhaz es Szakambulancia
      • Budapest, Hungary, 1146
        • Bethesda Childrens Hospital(Magyarországi Református Egyház Bethesda Gyermekkórháza)
    • Csongrád megye
      • Szeged, Csongrád megye, Hungary, 6725
        • Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar Gyermek
  • Italy
      • Catania, Italy, 95123
        • Azienda Ospedaliera Vittorio Emanuele Policlinico // Azienda Ospedaliera Policlinico San Marco
      • Genova, Italy, 16148
        • Ospedale Pediatrico Istituto Giannina Gaslini di Genova
    • LC
      • Bosisio Parini, LC, Italy, 23842
        • Istituto Di Ricovero E Cura A Carattere Scientifico IRCCS Eugenio Medea
    • Milano
      • Milan, Milano, Italy, 20133
        • IRCCS Istituto Neurologico Carlo Besta
    • Napoli
      • Naples, Napoli, Italy, 80131
        • Università Degli Studi Di Napoli Federico Ii
    • RM
      • Roma, RM, Italy, 00165
        • Ospedale Pediatrico Bambino Gesu
  • Poland
      • Krakow, Poland, 30-363
        • Centrum Medyczne Plejady
    • Poland
      • Poznan, Poland, Poland, 61-731
        • Clinical Research Center Sp. z o.o. Medic-R sp.k.
    • Pomeranian Voivodeship
      • Gdansk, Pomeranian Voivodeship, Poland, 80-542
        • Gdanskie Centrum Zdrowia Sp z o.o.
    • Silesian Voivodeship
      • Katowice, Silesian Voivodeship, Poland, 42-123
        • Wielospecjalistyczna Poradnia Lekarska Synapsis
    • Woj. Malopolskie
      • Krakow, Woj. Malopolskie, Poland, 31-503
        • Wojewdzki Specjalistyczny Szpital Dziecicy im. sw. Ludwika w Krakowie
  • Romania
      • Dorobanți, Romania, 41914
        • Spitalul Clinic de Psihiatrie Prof Dr Al. Obregia Bucureti
  • Serbia
      • Belgrade, Serbia, 11000
        • Clinic of Neurology and Psychiatry for Children and Adolescents
    • Belgrad
      • Belgrade, Belgrad, Serbia, 11120
        • Institute of Mental Health
    • Serbia
      • Niš, Serbia, Serbia, 18000
        • Clinical Centre Nis Center of Mental Health
      • Novi Sad, Serbia, Serbia, 21000
        • Clinical Center Vojvodina
  • Spain
      • Barcelona, Spain, 8036
        • Hospital Clinic de Barcelona
      • Seville, Spain, 41009
        • Hospital Universitario Virgen Macarena Unidad de Investigacion Neurologia
    • Madrid
      • Alcorcón, Madrid, Spain, 28922
        • Hospital Universitario Fundacion Alcorcon HUFA
      • Madrid, Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
      • Madrid, Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Marañón
    • Principality of Asturias
      • Oviedo, Principality of Asturias, Spain, 33011
        • Hospital Universitario Central de Asturias
    • Sevilla
      • Seville, Sevilla, Spain, 41013
        • Hospital Universitario Virgen del Rocío, C/Antonio Maura Montaner, s/n, edificio IBiS
  • United States
    • Alabama
      • Dothan, Alabama, United States, 36303
        • Harmonex Neuroscience Research
    • Arkansas
      • Little Rock, Arkansas, United States, 72202
        • Arkansas Children's Hospital
    • California
      • Anaheim, California, United States, 92805
        • Advanced Research Center
      • Bellflower, California, United States, 90706
        • CenExel CIT-IE
      • Glendale, California, United States, 91203
        • Cortica Site Network
      • Irvine, California, United States, 92604
        • Amnova Clinical Research
      • San Rafael, California, United States, 94903
        • Cortica Site Network - San Rafael
      • Santa Ana, California, United States, 92705
        • Syrentis Clinical Research
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Yale School of Medicine
    • Florida
      • Gainesville, Florida, United States, 32608
        • University of Florida
      • Gulf Breeze, Florida, United States, 32561
        • NW FL Clinical Research Group, LLC
      • Hialeah, Florida, United States, 33013-3834
        • Research in Miami Inc
      • Jensen Beach, Florida, United States, 34957
        • Emcrown Clinical Research
      • Miami, Florida, United States, 33136
        • University of Miami Miller School of Medicine
      • Miami, Florida, United States, 33173
        • Florida International Research Center
      • Miami, Florida, United States, 33175
        • Care Research Center
      • Orange City, Florida, United States, 32763
        • Medical Research Group of Central Florida
      • Orlando, Florida, United States, 32803
        • APG Research LLC
      • St. Petersburg, Florida, United States, 33701
        • University of South Florida
      • Tampa, Florida, United States, 33609-4181
        • Pediatric Epilepsy and Neurology Specialists
      • Tampa, Florida, United States, 33617
        • Jedidiah Clinical Research
      • Winter Park, Florida, United States, 32789
        • Pediatric Neurology, PA
    • Georgia
      • Atlanta, Georgia, United States, 30329
        • Rare Disease Research, LLC
      • Atlanta, Georgia, United States, 30338
        • Atlanta Behavioral Research, LLC.
      • Atlanta, Georgia, United States, 30318
        • Advanced Discovery Research, Llc
    • Illinois
      • Chicago, Illinois, United States, 60637-1447
        • The University of Chicago Hospitals
      • Chicago, Illinois, United States, 60611
        • Lurie Children Hospital of Chicago
      • Chicago, Illinois, United States, 60612
        • 1725 W. Harrison St., Suite 755
    • Indiana
      • Indianapolis, Indiana, United States, 46256
        • Josephson-Wallack-Munshower Neurology
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02115
        • Boston Children's Hospital
      • Worcester, Massachusetts, United States, 01655
        • UMass Chan Medical School
    • Michigan
      • Ann Arbor, Michigan, United States, 48105
        • Michigan Clinical Research Institute PC
      • Bloomfield Hills, Michigan, United States, 48302-1952
        • NeuroBehavioral Medicine Group
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • The Childrens Mercy Hospital
      • Saint Charles, Missouri, United States, 63304
        • Midwest Research Group
      • St Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • Nebraska
      • Lincoln, Nebraska, United States, 68526
        • Alivation Research
    • New York
      • New York, New York, United States, 10029-6504
        • Mount Sinai School of Medicine
      • New York, New York, United States, 10016-5815
        • NYU Child Study Center
      • Rochester, New York, United States, 14642
        • University of Rochester
      • Stony Brook, New York, United States, 11794
        • Stony Brook University Medical Center
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157-0001
        • Wake Forest Baptist Medical Center - PPDS
    • Ohio
      • Cincinnati, Ohio, United States, 45229-3026
        • Cincinnati Childrens Hospital Medical Center
      • Middleburg Heights, Ohio, United States, 44130
        • North Star Medical Research, LLC
    • Pennsylvania
      • Media, Pennsylvania, United States, 19063
        • Suburban Research Associates
    • South Carolina
      • Charleston, South Carolina, United States, 29414
        • Coastal Pediatric Research
    • Tennessee
      • Nashville, Tennessee, United States, 37203-6502
        • Access Clinical Trials, Inc.
      • Nashville, Tennessee, United States, 37232-7610
        • Vanderbilt University Medical Center
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
      • Houston, Texas, United States, 77030
        • The University of Texas Health Science Center at Houston
      • Houston, Texas, United States, 77030
        • Texas Children's Hospital (TCH)
      • Richmond, Texas, United States, 77407
        • Perceptive Pharma Research (PPR)
      • San Antonio, Texas, United States, 78249-3539
        • Road Runner Research Ltd.
    • Utah
      • Draper, Utah, United States, 84020
        • Cedar Clinical Research
    • Washington
      • Everett, Washington, United States, 98201
        • Core Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

6 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 1.8 mg/kg/day ecopipam (2 mg/kg/day ecopipam HCl)
Ecopipam 11.2, 22.4, 33.6, 44.8, 67.2 and 89.6 mg tablets (containing 12.5, 25, 37.5, 50, 75 and 100 mg ecopipam HCl, respectively); 1.8 mg/kg/day ecopipam (2 mg/kg/day ecopipam HCl) target dose; oral administration daily in evenings.
Drug: Ecopipam Hydrochloride
Selective dopamine D1 and D5 receptor antagonist
Placebo Comparator: Placebo during R/WD Phase
Matching Placebo tablets during R/WD period taken orally in the evening.
Drug: Ecopipam Hydrochloride
Selective dopamine D1 and D5 receptor antagonist

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time From Randomization to Relapse in Participants Greater Than and Equal to (>=) 6 and Less Than (<) 18 Years During the Double-Blind R/WD
Time Frame: From randomization at Week 12 through the end of the double-blind R/WD period (up to Week 24)
Time to relapse defined as a loss of >=50 percent (%) of the improvement experienced on the Yale Global Tic Severity Scale-Total Tic Score (YGTSS-TTS) from Baseline to the last visit in the Open-Label Stabilization Period (Week 12), or initiation of additional medications to treat symptoms of Tourette's Disorder (TD), or requirement of hospitalization for worsening symptoms of TD in participants between the ages of >= 6 and <18 years for ecopipam compared to those receiving placebo during the double-blind, R/WD period. The YGTSS was a clinician-completed rating scale used to quantify overall tic severity in participants with TD as well as specific subdomains of tic number, frequency, intensity, complexity and interference. Each of these subdomains was scored, on a 0 to 5 scale, separately for motor and vocal tics and then summed across both motor and vocal tics to yield a total tic score ranging from 0 to 50. Higher scores represented more severe symptoms.
From randomization at Week 12 through the end of the double-blind R/WD period (up to Week 24)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time From Randomization to Relapse in All Participants During the Double-Blind R/WD Period
Time Frame: From randomization at Week 12 through the end of the double-blind R/WD period (up to Week 24)
Time From Randomization (Week 12) to relapse defined as a loss of >= 50% of the improvement experienced on the YGTSS-TTS from Baseline to the last visit in the Open-Label Stabilization Period (Week 12), or initiation of additional medications to treat symptoms of TD, or requirement of hospitalization for worsening symptoms of TD in all participants during the Double-Blind R/WD period for ecopipam compared to placebo. The YGTSS was a clinician-completed rating scale used to quantify overall tic severity in children and adults with TD as well as specific subdomains of tic number, frequency, intensity, complexity and interference. Each of these subdomains was scored, on a 0 to 5 scale, separately for motor and vocal tics and then summed across both motor and vocal tics to yield a total tic score ranging from 0 to 50. Higher scores represented more severe symptoms.
From randomization at Week 12 through the end of the double-blind R/WD period (up to Week 24)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Emalex Biosciences Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 31, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 13, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 4, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 7, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 7, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 14, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EBS-101-TD-301
  • 2023-503494-38-00 (Ctis)
  • 2022-001961-11 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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