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Trial record 1 of 2 for:    emalex | Tourette Syndrome
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Ecopipam Tablets to Study Tourette Syndrome in Children and Adolescents - Open Label Extension (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: NCT04114539
Recruitment Status : Recruiting
First Posted : October 3, 2019
Last Update Posted : October 3, 2019
Sponsor:
Information provided by (Responsible Party):
Emalex Biosciences Inc.

Brief Summary:
This study is an international, multicenter, open-label, long term extension study evaluating the safety of ecopipam tablets for the treatment of children and adolescent subjects with Tourette Syndrome.

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

Detailed Description:
This is an international, multicenter, open-label, long term extension study evaluating the safety of ecopipam tablets for the treatment of pediatric subjects (aged ≥6 to ≤18 years at Baseline) with Tourette Syndrome. Subjects who completed the Phase 2b, randomized, double-blind, efficacy and safety study (EBS-101-CL-001) without major reportable protocol deviations, and who meet all the inclusion/exclusion criteria for this study will be eligible to participate in this study. All subjects who provide informed consent and participate in this study will be titrated to a target dose of 2 mg/kg/day. All participants rolling over from the Phase 2b double-blind efficacy and safety study will be tapered off of study medication to maintain the blind from that study. Subjects will complete study visits every month for 1 year. Follow Up visits will be conducted 7 and 14 days after the last dose of study medication and a Follow Up phone call will be conducted 30 days after the last dose of study medication.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Open Label
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Open-Label, Extension Study Intended to Evaluate the Long-term Safety of Ecopipam Tablets in Children and Adolescent Subjects With Tourette's Syndrome
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ecopipam Drug: Ecopipam
Ecopipam HCl 12.5-, 37.5-. 50-, 75- and 100-mg tablets; 2 mg/kg/day target dose; oral administration daily in evenings.




Primary Outcome Measures :
  1. Incidence of Treatment Emergent Adverse Events [ Time Frame: 12 months ]
    Adverse Events, which include clinical laboratory test variables, will be documented from the time of the first study medication administration from the open label study until the subject's study participation is complete (study discontinuation and up to 30-days follow-up). All adverse events that occur after the first study medication application and up to 30 days after the subject's last study medication application will be considered treatment emergent adverse events.



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects must have completed the EBS-101-CL-001 study through the Day 14 Follow Up Visit within the last 30 days (or longer with permission of the medical monitor) without a major reportable protocol deviation and must be someone the Investigator feels would benefit from continued participation.

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.
  • Positive urine drug screen.
  • Certain medications that would lead to drug interactions.

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): NCT04114539


Locations
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United States, Texas
North Texas Clinical Trials Recruiting
Fort Worth, Texas, United States, 76104
Contact: Brian Maynard, PhD    817-744-8844    brian.maynard@ntxct.com   
Sponsors and Collaborators
Emalex Biosciences Inc.

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Responsible Party: Emalex Biosciences Inc.
ClinicalTrials.gov Identifier: NCT04114539    
Other Study ID Numbers: EBS-101-OL-001
First Posted: October 3, 2019    Key Record Dates
Last Update Posted: October 3, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Emalex Biosciences Inc.:
Tourette Syndrome
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