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

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ClinicalTrials.gov Identifier: NCT05615220
Recruitment Status : Recruiting
First Posted : November 14, 2022
Last Update Posted : March 9, 2023
Information provided by (Responsible Party):
Emalex Biosciences Inc.

Brief 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 double-blind, placebo-controlled, randomized withdrawal period.

Condition or disease Intervention/treatment Phase
Tourette Disorder Drug: Ecopipam Hydrochloride Phase 3

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 During the 12-week R/WD period, any subject meeting Relapse criteria will be withdrawn from blinded study medication and complete end of study assessments including safety follow up visits.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 196 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: This is a multicenter study which includes an open-label period followed by double-blind, placebo-controlled, randomized withdrawal period.
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: This includes an open-label period followed by double-blind, placebo-controlled, randomized withdrawal period.
Primary Purpose: Treatment
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
Actual Study Start Date : January 31, 2023
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Yale Global Tic Severity Scale (YGTSS) [ Time Frame: Screening up to Week 24 ]
    Clinician-completed rating scale with score ranging from 0 to 50 (0=none to 50=severe)

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05615220

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Contact: Meredith M Miller 773 343 0671 mmiller@emalexbiosciences.com
Contact: David JB Kim 312 847 1342 dkim@emalexbiosciences.com

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United States, Alabama
Harmonex Neuroscience Research Recruiting
Dothan, Alabama, United States, 36303
Contact: Nelson Handal-Thome, MD    334-836-2000    nhandal@harmonex.us   
United States, Florida
NW FL Clinical Research Group, LLC Recruiting
Gulf Breeze, Florida, United States, 32561
Contact: Weldon Mauney, MD    850-934-1299    wmauney@nwflcrg.com   
Research in Miami Inc Recruiting
Hialeah, Florida, United States, 33013-3834
Contact: Dolores Sanchez Cazau    305-889-6670    dcazau@researchinmiami.com   
APG Research LLC Recruiting
Orlando, Florida, United States, 32803
Contact: Morteza Nadjafi, MD    407-921-2448    MORIAPG@GMAIL.COM   
United States, Illinois
Chicago Research Center Recruiting
Chicago, Illinois, United States, 60634
Contact: Monika Jaffe, MD    773-282-9845    monika.jaffe@chicagoresearchcenter.com   
United States, Indiana
Josephson-Wallack-Munshower Neurology Recruiting
Indianapolis, Indiana, United States, 46256
Contact: Keith Ridel, MD    317-537-6058    ridelkands@gmail.com   
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Daniel Geller, MD    617-724-5141    dan.geller@mgh.harvard.edu   
United States, Nebraska
Alivation Research, LLC Recruiting
Lincoln, Nebraska, United States, 68526
Contact: Walter Duffy, MD    402-817-2235    drduffy@alivation.com   
United States, Pennsylvania
Suburban Research Associates Recruiting
Media, Pennsylvania, United States, 19063
Contact: Shivkumar S Hatti, MD    610-891-9024    shatti@surburanresearch.com   
United States, South Carolina
Coastal Pediatric Research Recruiting
Charleston, South Carolina, United States, 29414
Contact: Rebecca Lehman, MD    843-518-5642    rebecca.lehman@uscmed.sc.edu   
United States, Tennessee
Access Clinical Trials, Inc. Recruiting
Nashville, Tennessee, United States, 37203-6502
Contact: James (Alan) Fry, MD    615-320-6076    drafry@accessclintrials.com   
United States, Texas
Road Runner Research Ltd. Recruiting
San Antonio, Texas, United States, 78249-3539
Contact: Jerry Tomasovic    210-949-0505    jtomasovic@rrresearchsa.com   
United States, Utah
Cedar Clinical Research Not yet recruiting
Draper, Utah, United States, 84020
Contact: Reid Robison, MD    801-369-8989    reid.robinson@numinus.com   
Sponsors and Collaborators
Emalex Biosciences Inc.
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Responsible Party: Emalex Biosciences Inc.
ClinicalTrials.gov Identifier: NCT05615220    
Other Study ID Numbers: EBS-101-TD-301
First Posted: November 14, 2022    Key Record Dates
Last Update Posted: March 9, 2023
Last Verified: January 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tourette Syndrome
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tic Disorders
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Neurodevelopmental Disorders
Mental Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action