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Ecopipam Tablets to Study Tourette's Syndrome in Children and Adolescents (D1AMOND)

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ClinicalTrials.gov Identifier: NCT04007991
Recruitment Status : Recruiting
First Posted : July 5, 2019
Last Update Posted : March 9, 2021
Sponsor:
Information provided by (Responsible Party):
Emalex Biosciences Inc.

Tracking Information
First Submitted Date  ICMJE July 2, 2019
First Posted Date  ICMJE July 5, 2019
Last Update Posted Date March 9, 2021
Actual Study Start Date  ICMJE June 20, 2019
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 2, 2019)		 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)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ecopipam Tablets to Study Tourette's Syndrome in Children and Adolescents
Official Title  ICMJE 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
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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Tourette Syndrome in Children; Tourette Syndrome in Adolescents
Intervention  ICMJE Drug: Ecopipam
Ecopipam tablets administered PO to establish 2 mg/kg/day; Matching Placebo
Study Arms  ICMJE
  • 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
    Intervention: Drug: Ecopipam
  • Placebo Comparator: Placebo
    Matching Placebo tablets taken orally in the evening
    Intervention: Drug: Ecopipam
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 2, 2019)		 150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2021
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: David Kim 847-715-0562 dkim@emalexbiosciences.com
Contact: Meredith Miller mmiller@emalexbiosciences.com
Listed Location Countries  ICMJE Canada,   France,   Germany,   Hungary,   Italy,   Poland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04007991
Other Study ID Numbers  ICMJE EBS-101-CL-001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Emalex Biosciences Inc.
Study Sponsor  ICMJE Emalex Biosciences Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Emalex Biosciences Inc.
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP