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Tourette DisorderPhase 3D1AMONDNCT05615220

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

A Phase 3 study testing Ecopipam Hydrochloride in people with Tourette Disorder, run by Emalex Biosciences Inc. at 95 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 6 years and older
Conditions the study is for
Tourette Disorder
What is being tested?
Ecopipam Hydrochloride
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
216 participants
Where
95 sitesin 12 countries
Study dates
31 Jan 2023to 4 Feb 2025
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • ≥ 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

95 sites in 12 countries.

95 sites in 12 countries

United States56 sites

  • Advanced Research Center

    Anaheim, California, 92805

  • Michigan Clinical Research Institute PC

    Ann Arbor, Michigan, 48105

  • Advanced Discovery Research, LLC

    Atlanta, Georgia, 30318

  • Rare Disease Research, LLC

    Atlanta, Georgia, 30329

  • Atlanta Behavioral Research, LLC.

    Atlanta, Georgia, 30338

  • CenExel CIT-IE

    Bellflower, California, 90706

  • Neurobehavioral Medicine Group

    Bloomfield Hills, Michigan, 48302-1952

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Boston Children's Hospital

    Boston, Massachusetts, 02115

  • Coastal Pediatric Research

    Charleston, South Carolina, 29414

  • Lurie Children Hospital of Chicago

    Chicago, Illinois, 60611

  • 1725 W. Harrison St., Suite 755

    Chicago, Illinois, 60612

  • The University of Chicago Hospitals

    Chicago, Illinois, 60637-1447

  • Cincinnati Childrens Hospital Medical Center

    Cincinnati, Ohio, 45229-3026

  • Harmonex Neuroscience Research

    Dothan, Alabama, 36303

  • Cedar Clinical Research

    Draper, Utah, 84020

  • Core Clinical Research

    Everett, Washington, 98201

  • University of Florida

    Gainesville, Florida, 32608

  • Cortica Site Network

    Glendale, California, 91203

  • NW FL Clinical Research Group, LLC

    Gulf Breeze, Florida, 32561

  • Research in Miami Inc

    Hialeah, Florida, 33013-3834

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Texas Children's Hospital (TCH)

    Houston, Texas, 77030

  • The University of Texas Health Science Center at Houston

    Houston, Texas, 77030

  • Josephson-Wallack-Munshower Neurology

    Indianapolis, Indiana, 46256

  • Amnova Clinical Research

    Irvine, California, 92604

  • Emcrown Clinical Research

    Jensen Beach, Florida, 34957

  • The Childrens Mercy Hospital

    Kansas City, Missouri, 64108

  • Alivation Research

    Lincoln, Nebraska, 68526

  • Arkansas Children's Hospital

    Little Rock, Arkansas, 72202

  • Suburban Research Associates

    Media, Pennsylvania, 19063

  • University of Miami Miller School of Medicine

    Miami, Florida, 33136

  • Florida International Research Center

    Miami, Florida, 33173

  • Care Research Center

    Miami, Florida, 33175

  • North Star Medical Research, LLC

    Middleburg Heights, Ohio, 44130

  • Access Clinical Trials, Inc.

    Nashville, Tennessee, 37203-6502

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232-7610

  • Yale School of Medicine

    New Haven, Connecticut, 06519

  • NYU Child Study Center

    New York, New York, 10016-5815

  • Mount Sinai School of Medicine

    New York, New York, 10029-6504

  • Medical Research Group of Central Florida

    Orange City, Florida, 32763

  • APG Research LLC

    Orlando, Florida, 32803

  • Perceptive Pharma Research (PPR)

    Richmond, Texas, 77407

  • University of Rochester

    Rochester, New York, 14642

  • Midwest Research Group

    Saint Charles, Missouri, 63304

  • Road Runner Research Ltd.

    San Antonio, Texas, 78249-3539

  • Cortica Site Network - San Rafael

    San Rafael, California, 94903

  • Syrentis Clinical Research

    Santa Ana, California, 92705

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • University of South Florida

    St. Petersburg, Florida, 33701

  • Stony Brook University Medical Center

    Stony Brook, New York, 11794

  • Pediatric Epilepsy and Neurology Specialists

    Tampa, Florida, 33609-4181

  • Jedidiah Clinical Research

    Tampa, Florida, 33617

  • Wake Forest Baptist Medical Center - PPDS

    Winston-Salem, North Carolina, 27157-0001

  • Pediatric Neurology, PA

    Winter Park, Florida, 32789

  • Umass Chan Medical School

    Worcester, Massachusetts, 01655

Other trials in United States

Spain7 sites

  • Hospital Universitario Fundacion Alcorcon HUFA

    Alcorcón, Madrid, 28922

  • Hospital Clínic de Barcelona

    Barcelona, 8036

  • Hospital General Universitario Gregorio Maranon

    Madrid, Madrid, 28007

  • Hospital Universitario 12 de Octubre

    Madrid, Madrid, 28041

  • Hospital Universitario Central de Asturias

    Oviedo, Principality of Asturias, 33011

  • Hospital Universitario Virgen del Rocío, C/Antonio Maura Montaner, s/n, edificio IBiS

    Seville, Sevilla, 41013

  • Hospital Universitario Virgen Macarena Unidad de Investigacion Neurologia

    Seville, 41009

Other trials in Spain

Italy6 sites

  • Istituto Di Ricovero E Cura A Carattere Scientifico IRCCS Eugenio Medea

    Bosisio Parini, LC, 23842

  • Azienda Ospedaliera Vittorio Emanuele Policlinico // Azienda Ospedaliera Policlinico San Marco

    Catania, 95123

  • Ospedale Pediatrico Istituto Giannina Gaslini di Genova

    Genova, 16148

  • IRCCS Istituto Neurologico Carlo Besta

    Milan, Milano, 20133

  • Universita degli Studi di Napoli Federico II

    Naples, Napoli, 80131

  • Ospedale Pediatrico Bambino Gesù

    Roma, RM, 00165

Other trials in Italy

Poland5 sites

  • Gdanskie Centrum Zdrowia Sp z o.o.

    Gdansk, Pomeranian Voivodeship, 80-542

  • Wielospecjalistyczna Poradnia Lekarska Synapsis

    Katowice, Silesian Voivodeship, 42-123

  • Wojewdzki Specjalistyczny Szpital Dziecicy im. sw. Ludwika w Krakowie

    Krakow, Woj. Malopolskie, 31-503

  • Centrum Medyczne Plejady

    Krakow, 30-363

  • Clinical Research Center Sp. z o.o. MEDIC-R Sp.k.

    Poznan, Poland, 61-731

Other trials in Poland

Bulgaria4 sites

  • Center Spectar-Plovdiv

    Plovdiv, Bulgaria, 4004

  • ASMP-IP- d-r Kayryakova

    Sofia, Sofia-Grad, 1360

  • Kalimat Medical Center_Sofia

    Sofia, 1680

  • DCC Mladost-M Varna

    Varna, 9020

Other trials in Bulgaria

Serbia4 sites

  • Institute of Mental Health

    Belgrade, Belgrad, 11120

  • Clinic of Neurology and Psychiatry for Children and Adolescents

    Belgrade, 11000

  • Clinical Centre Nis Center of Mental Health

    Niš, Serbia, 18000

  • Clinical Center Vojvodina

    Novi Sad, Serbia, 21000

Other trials in Serbia

France3 sites

  • CHU Grenoble Alpes - Hopital Couple Enfant

    Grenoble, 38000

  • Hôpital Fondation Rothschild

    Paris, 75019

  • CHU Strasbourg-Hopital de Hautepierre

    Strasbourg, 67098

Other trials in France

Germany3 sites

  • Department of Psychiatry, Socialpsychiatry and Psychotherapy, Hannover Medical School

    Hanover, Lower Saxony, 30625

  • Zentralinstitut fuer Seelische Gesundheit, Mannheim

    Mannheim, 68159

  • Psychiatric Clinic of Ludwig Maximilians Universitaet Muenchen

    Munich, Bavaria, 80336

Other trials in Germany

Hungary3 sites

  • Vadaskert Gyermek- es Ifjusagpszichiatriai Korhaz es Szakambulancia

    Budapest, 1021

  • Bethesda Childrens Hospital(Magyarországi Református Egyház Bethesda Gyermekkórháza)

    Budapest, 1146

  • Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar Gyermek

    Szeged, Csongrád megye, 6725

Other trials in Hungary

Canada2 sites

  • The Kids Clinic Inc

    Ajax, Ontario, L1Z 0M1

  • University of Calgary

    Calgary, Alberta, T2N 4Z6

Other trials in Canada

Denmark1 site

  • Borne og Ungeafdelingen

    Herlev, 02730

Other trials in Denmark

Romania1 site

  • Spitalul Clinic de Psihiatrie Prof Dr Al. Obregia Bucureti

    Dorobanți, 41914

Other trials in Romania

About this study

Official title: 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.

Read the 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.

Being tested
Ecopipam Hydrochloride
Medical subject headings
Tourette Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ecopipam HydrochlorideDrug

    Selective dopamine D1 and D5 receptor antagonist

Study groups in NCT05615220
Study groupRoleWhat they receive
1.8 mg/kg/day ecopipam (2 mg/kg/day ecopipam HCl)ExperimentalEcopipam 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.
Receives: Drug: Ecopipam Hydrochloride
Placebo during R/WD PhasePlacebo comparatorMatching Placebo tablets during R/WD period taken orally in the evening.
Receives: Drug: Ecopipam Hydrochloride

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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 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.

    Measured: From randomization at Week 12 through the end of the double-blind R/WD period (up to Week 24)

Secondary outcomes (1)

  1. Time From Randomization to Relapse in All Participants During the Double-Blind R/WD Period

    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.

    Measured: From randomization at Week 12 through the end of the double-blind R/WD period (up to Week 24)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Nov 2022
  2. Study start31 Jan 2023
  3. Primary completion13 Jan 2025
  4. Study completion4 Feb 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Model description
Sequential Assignment This is a multicenter study which includes an open-label period followed by double-blind, placebo-controlled, randomized withdrawal period.
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
216 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05615220
Sponsor's protocol ID
EBS-101-TD-301
Other IDs
2023-503494-38-00, 2022-001961-11, 2023
Acronym
D1AMOND
Status last verified
Apr 2025
First submitted
7 Nov 2022
Last updated
12 Jun 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Gilbert DL, Atkinson SD, Kim DJB, Miller MM, Rice PM, Flatt JA, Karkanias GB, Munschauer FE, Bittman RM, Wanaski SP, Cunniff TM, Tomczak KK. Efficacy and Safety of Ecopipam for Tourette Syndrome: A Phase 3 Randomized Clinical Trial. JAMA Neurol. 2026 Jul 1;83(7):645-653. doi: 10.1001/jamaneurol.2026.1431.

    PubMed 42189524

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ecopipam Hydrochloride in people with Tourette Disorder, run by Emalex Biosciences Inc. at 95 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 95 sites in United States, Spain, Italy, Poland, Bulgaria and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05615220, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.

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