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Ecopipam Tablets to Study Tourette's Syndrome in Children and Adolescents (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: NCT04007991
Recruitment Status : Recruiting
First Posted : July 5, 2019
Last Update Posted : October 8, 2020
Sponsor:
Information provided by (Responsible Party):
Emalex Biosciences Inc.

Study Description
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Brief Summary:
This study evaluates the effect of ecopipam tablets in children and adolescents in the treatment of Tourette's Syndrome (TS). Half of the participants will receive ecopipam tablets, while the other half will receive matching placebo tablets

Condition or disease Intervention/treatment Phase
Tourette Syndrome in Children; Tourette Syndrome in Adolescents Drug: Ecopipam Phase 2

Detailed Description:
Multicenter, placebo-controlled, double-blind, randomized, parallel-group, Phase 2b study in pediatric subjects (aged greater than equal to 6 to less than 18 years of age) with TS. Following a 28-day Screening period and Baseline visit, eligible subjects will be randomized 1:1 to receive either ecopipam hydrochloride (HCl) or matching placebo for a 12 week treatment period. Doses will be titrated up and down from target dose of 2 mg/kg/day. Follow Up visit will be conducted after the last dose of study medication.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Multicenter, Placebo-Controlled, Double-Blind, Randomized, Parallel-Group, Phase 2b Study to Evaluate the Efficacy and Safety of Ecopipam in Children and Adolescents With Tourette's Syndrome
Actual Study Start Date : June 20, 2019
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Ecopipam 2 mg/kg/day
Ecopipam HCl 12.5-, 50-, 75- and 100-mg tablets; 2 mg/kg/day target dose; oral administration daily in evenings
 Drug: Ecopipam
Ecopipam tablets administered PO to establish 2 mg/kg/day; Matching Placebo
Placebo Comparator: Placebo
Matching Placebo tablets taken orally in the evening
 Drug: Ecopipam
Ecopipam tablets administered PO to establish 2 mg/kg/day; Matching Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Yale Global Tic Severity Scale (YGTSS) [ Time Frame: Screening through Week 12 ]
    Clinician-completed rating scale with score ranging from 0 to 50 (0=none to 50=severe)


Eligibility Criteria
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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ≥ 6 and < 18 years of age
  • ≥ 18 kg (~ 40 lbs.)
  • TS diagnosis and both motor and vocal tics that cause impairment with normal routines
  • Minimum score of 20 on the YGTSS-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:

  • 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
Contacts and Locations
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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): NCT04007991


Contacts
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Contact: David Kim 847-715-0562 dkim@emalexbiosciences.com
Contact: Meredith Miller mmiller@emalexbiosciences.com

Locations
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Sponsors and Collaborators
Emalex Biosciences Inc.
More Information
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Responsible Party: Emalex Biosciences Inc.
ClinicalTrials.gov Identifier: NCT04007991    
Other Study ID Numbers: EBS-101-CL-001
First Posted: July 5, 2019    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020

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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
Syndrome
Disease
Pathologic Processes
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