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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05615220
Recruitment Status : Not yet recruiting
First Posted : November 14, 2022
Last Update Posted : January 18, 2023
Sponsor:
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 During the 12-week R/WD period, any subject meeting Relapse criteria will be withdrawn from blinded study medication and complete end of study assessments including safety follow up visits.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
Estimated Study Start Date : February 2023
Estimated Primary Completion Date : November 2024
Estimated Study Completion Date : November 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
Criteria

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


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

Locations
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United States, Florida
APG Research LLC
Orlando, Florida, United States, 32803
Contact: Morteza Nadjafi, MD         
United States, Tennessee
Access Clinical Trials, Inc.
Nashville, Tennessee, United States, 37203-6502
Contact: James (Alan) Fry, MD         
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Contact: Arjun Tarakad, MD         
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: January 18, 2023
Last Verified: November 2022

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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
Ecopipam
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