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Tourette SyndromePhase 3NCT06021522

A Study to Evaluate Long-term Safety of Ecopipam Tablets in Children, Adolescents and Adults With Tourette's Disorder

A Phase 3 study testing Ecopipam in people with Tourette Syndrome, run by Emalex Biosciences Inc. at 67 sites in 8 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The primary objective of this study is to evaluate the long-term safety and tolerability of ecopipam tablets in children (greater than or equal to [>=] 6 and less than [<] 12 years of age), adolescents (>=12 and <18 years of age), and adults (>=18 years of age) with Tourette's Syndrome (TS). Read more about this study

Who is it for?
Ages 6 years and older
Conditions the study is for
Tourette Syndrome
What is being tested?
Ecopipam
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
67 sitesin 8 countries
Study dates
16 Aug 2023to Feb 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

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 to >=18 years of age.
  • Participants enrolling from the study EBS-101-TD-301; completed all visits through Week 24 and days 7 and 14 safety follow-up, met relapse criteria during the double-blind randomized (R/WD) period after completing the 301 end of trial (ET) visit, the 7 day and 14 day safety follow up visits, but not before 24 weeks following the 301 baseline visit or participants who met relapse criteria will be eligible after completing early termination visit, Day 7 and Day 14 follow up visits.
  • Participants who completed the studies EBS-101-OL-001 or PSY302A.
  • The enrolling participant must have had clinical benefit from ecopipam and would benefit from continued participation.
  • Effective contraception during the study and 30 days after last study dose for sexually active participants
  • <18 years of age participants parent/legal guardian must sign a written informed consent and participant must sign a written informed assent.
  • Participant must have TD based on Diagnostic and Statistical Manual for Mental Disorders - 5th Edition (DSM-5-TR diagnostic criteria) for TD.
  • TD diagnosis and both motor and vocal tics that cause impairment with normal routines

Who cannot join

  • The participants who discontinued the studies PSY-302A, EBS-101-OL-001 or EBS-101-TD-301 due to reasons such as either lost to follow up, withdrawn consent, non-compliant or withdrawn by the discretion of either the site investigator or the sponsor.
  • Participants with ongoing or past history of neurological condition (example [e.g.], Huntington's disease, Parkinson's disease, Wilson's disease, stroke, Restless Legs Syndrome).
  • Any unstable mood disorder (DSM-5-TR criteria), mental illness or clinically significant lab abnormalities, moderate to severe renal or hepatic impairment, a PHQ-9 score >=10 at screening and history of neuroleptic malignant syndrome at the time of screening or baseline.
  • Participants who completed the studies EBS-101-OL-001 or PSY-302A and who had previous exposure to ecopipam and oral neuroleptics within 4 weeks and depot neuroleptics within 3 months prior to screening, 6 months prior to Baseline.
  • Participants receiving any other medication to treat motor or vocal tics and anti-depressant or anti-anxiety medications.
  • Risk of suicide as per PI judgement
Show all 16Show fewer
  • Pregnant or lactating women
  • Certain medications that would have unfavorable drug interactions with ecopipam, e.g., digoxin, fluoxetine, valproic acid, bupropion.
  • Current or recent (past 3 months) DSM-5-TR substance use disorder (with the exception of nicotine).
  • Recent behavioral therapy
  • Positive urine drug screen for cocaine, amphetamine, benzodiazepines, barbiturates, phencyclidine (PCP) or opiates at Baseline, except those receiving stable, prescribed treatment for attention deficit/hyperactivity disorder (ADHD)
  • Lifetime history of bipolar disorder type I or II, dementia, schizophrenia, or any other psychotic disorder.
  • Unable to swallow tablets.
  • Known hypersensitivity to any of ecopipam's excipients.
  • History of seizures (excluding febrile seizures that occurred >2 years prior to Baseline).
  • Myocardial infarction within 6 months from Screening.

Trial locations and contacts

67 sites in 8 countries.

67 sites in 8 countries

United States44 sites

  • Advanced Research Center

    Anaheim, California, 92805

  • Michigan Clinical research Institute PC

    Ann Arbor, Michigan, 48105

  • Rare Disease Research, LLC

    Atlanta, Georgia, 30329

  • Kennedy Krieger Institute

    Baltimore, Maryland, 21205

  • CenExel CIT-IE

    Bellflower, California, 90706

  • Neurobahavioral Medicine Group

    Bloomfield Hills, Michigan, 48302

  • Mass General Hospital

    Boston, Massachusetts, 02114

  • Boston Childrens Hospital

    Boston, Massachusetts, 02115

  • Coastal Pediatric Research

    Charleston, South Carolina, 29414

  • OnSite Clinical Solutions LLC

    Charlotte, North Carolina, 28211

  • Lurie Children Hospital of Chicago

    Chicago, Illinois, 60611

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229

  • National Childrens Hospital - The Ohio State University

    Columbus, Ohio, 43205

  • UT Southwestern

    Dallas, Texas, 75390

  • Harmonex, Inc.

    Dothan, Alabama, 36303

  • Cedar Clinical Research

    Draper, Utah, 84020

  • Core Clinical Research

    Everett, Washington, 98201

  • Cortica Site Network

    Glendale, California, 91203

  • NW FL Clinical Research Group, LLC

    Gulf Breeze, Florida, 32561

  • Research in Miami Inc

    Hialeah, Florida, 33013-3834

  • The University of Texas Health Science Center at Houston

    Houston, Texas, 77030

  • Josephson-Wallack-Munshower Neurology

    Indianapolis, Indiana, 46256

  • Alivation Research

    Lincoln, Nebraska, 68526

  • Arkansas Children's Hospital

    Little Rock, Arkansas, 72202

  • University of Louisville Research Foundation Inc.

    Louisville, Kentucky, 40202

  • University of Miami Miller School of Medicine

    Miami, Florida, 33136

  • Florida International Research Center

    Miami, Florida, 33173

  • North Star Medical Research, LLC

    Middleburg Heights, Ohio, 44130

  • Access Clinical Trials, Inc.

    Nashville, Tennessee, 37203-6502

  • Access Clinical Trials, Inc.

    Nashville, Tennessee, 37203

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232-2551

  • Yale School of Medicine

    New Haven, Connecticut, 06519

  • Medical Research Group of Central Florida

    Orange City, Florida, 32763

  • APG Research, LLC

    Orlando, Florida, 32803

  • Providence Brain and Spine Institute

    Portland, Oregon, 97225

  • University of Rochester

    Rochester, New York, 14642

  • Road Runner Research, Ltd

    San Antonio, Texas, 78249

  • Cortica Site Network - San Rafael

    San Rafael, California, 94903

  • St. Louis Children's Hospital

    St Louis, Missouri, 63110

  • University of South Florida

    St. Petersburg, Florida, 33701

  • Pediatric Epilepsy and Neurology Specialists

    Tampa, Florida, 33609

  • Childrens National Hospital

    Washington D.C., District of Columbia, 20010

  • Umass Chan Medical School

    Worcester, Massachusetts, 01655

Other trials in United States

Italy5 sites

  • Azienda Ospedaliero Universitaria " G. Rodolico - San Marco"

    Catania, 95123

  • Istituto Giannina Gaslini, Universita di Genova

    Genova, GE, 16148

  • IRCCS Istituto Neurologico Carlo Besta

    Milan, 20133

  • Universita degli Studi di Napoli Federico II

    Naples, Napoli, 80131

  • Ospedale Pediatrico Bambino Ges

    Roma, RM, 165

Other trials in Italy

Poland5 sites

  • Gdanskie Centrum Zdrowia Sp z o.o.

    Gdansk, Pomeranian Voivodeship, 80-542

  • Neurologia Śląska Centrum Medyczne

    Katowice, Poland, 40-689

  • 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, Wielkopolska, 61-731

Other trials in Poland

Spain4 sites

  • 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

    Seville, Sevilla, 41013

Other trials in Spain

Bulgaria3 sites

  • Center Spectar-Plovdiv

    Plovdiv, Bulgaria, 4004

  • ASMP-IP- d-r Kayryakova

    Sofia, Sofia-Grad, 1360

  • Kalimat Medical Center_Sofia

    Sofia, 1680

Other trials in Bulgaria

Serbia3 sites

  • Institute of Mental Health

    Belgrade, Belgrad, 11120

  • Clinic of Neurology and Psychiatry for Children and Adolescents

    Belgrade, Grad Beograd, 1100

  • Clinical Centre Nis Center of Mental Health

    Niš, Serbia, 18000

Other trials in Serbia

Hungary2 sites

  • Bethesda Childrens Hospital(Magyarországi Református Egyház Bethesda Gyermekkórháza)

    Budapest, 1146

  • Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar Gyermek-es Ifjusagpszicihatria

    Szeged, Hungary, 6720

Other trials in Hungary

Canada1 site

  • The Kids Clinic Inc

    Ajax, Ontario, L1Z 0M1

Other trials in Canada

About this study

Official title: A Multicenter, Open-Label, Study to Evaluate the Long-term Safety of Ecopipam Tablets in Children, Adolescents and Adults With Tourette's Disorder

The primary objective of this study is to evaluate the long-term safety and tolerability of ecopipam tablets in children (greater than or equal to [>=] 6 and less than [<] 12 years of age), adolescents (>=12 and <18 years of age), and adults (>=18 years of age) with Tourette's Syndrome (TS).

Read the detailed description

This study is to evaluate the long-term safety and tolerability of ecopipam tablets in eligible participants. The eligible participants will be entered into a treatment period and start a 4-week titration phase to achieve a target steady-state dose of 1.8 milligram per kilogram per day (mg/kg/day) ecopipam (2 mg/kg/day dose of ecopipam HCl). During the 4-week titration phase ecopipam will be dispensed following weight bands before reaching their respective maintenance dose until end of the treatment. Safety assessment will be conducted at baseline visit and at all treatment visits (Months 1-12, 15, 18, 21 and 24). Safety follow up visits will be conducted 7 and 14 days and a follow up phone call will be conducted 30 days after the last dose of ecopipam.

Being tested
Ecopipam
Keywords
Ecopipam, Neurodevelopmental Disorders, Mental Disorders, Central Nervous System Depressants, Neurodegenerative Diseases, Movement Disorders, Tic Disorders, Nervous System Diseases, Central Nervous System Diseases, Brain Diseases
Medical subject headings
Tourette Syndrome, Neurodevelopmental Disorders, Mental Disorders, Neurodegenerative Diseases, Movement Disorders, Tic Disorders, Nervous System Diseases, Central Nervous System Diseases

What participants receive

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

  • EcopipamDrug

    Also called Ecopipam Hydrochloride

    Selective dopamine D1 and D5 receptor antagonist

Study groups in NCT06021522
Study groupRoleWhat they receive
Ecopipam 1.8 mg/kg/dayExperimentalEcopipam tablets will be administered orally (PO) once daily in the evening without regard to meals at concentrations 11.2, 22.4, 33.6, 44.8, 67.2 and 89.6 milligrams (mg) containing 12.5, 25, 37.5, 50, 75 and 100 mg ecopipam HCl, respectively in 4-week titration phase to achieve a target dose of 1.8 milligram per kilogram per day (mg/kg/day) ecopipam (2 mg/kg/day ecopipam HCl). Participants will be evaluated for safety at each baseline visit and at all treatment visits up to 24 months and at follow up visits at 7 and 14 days after last dose of ecopipam.
Receives: Drug: Ecopipam

What is being measured

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

  1. Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

    An adverse event (AE) is defined as any untoward medical occurrence in a subject administered a study drug and which does not necessarily have a causal relationship with this treatment. A TEAE is the development of an undesirable medical condition or the deterioration of a pre-existing medical condition following or during exposure to a pharmaceutical product, whether or not considered casually related to the product.

    Measured: Baseline up to Month 24

Timeline

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

  1. First posted1 Sep 2023
  2. Study start16 Aug 2023
  3. Primary completionFeb 2028 (estimated)
  4. Study completionFeb 2028 (estimated)

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06021522
Sponsor's protocol ID
EBS-101-TD-391
Other IDs
2023-503545-67-00, 2023
Status last verified
Jul 2026
First submitted
11 Jul 2023
Last updated
22 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ecopipam in people with Tourette Syndrome, run by Emalex Biosciences Inc. at 67 sites in 8 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 8 inclusion and 16 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: under way, not looking for participants, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 67 sites in United States, Italy, Poland, Spain, Bulgaria and 3 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. 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?

This study is still under way. Results are not available in the source record yet.

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?

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (time frame: Baseline up to Month 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 NCT06021522.

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 22 Jul 2026.

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