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D1AMOND

  • Status
    Accepting Candidates
  • Age
    6 Years - N/A
  • Sexes
    All
  • Healthy Volunteers
    No
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Objective

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.

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 During the 12-week R/WD period, any subject meeting Relapse criteria will be withdrawn from blinded study medication and complete end of study assessments including safety follow up visits.

Details

Full study 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
Protocol number OCR43240
ClinicalTrials.gov ID NCT05615220
Phase Phase 3

Eligibility

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

Lead researcher

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  1. Step
    1

    Contact the research team

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  2. Step
    2

    Get screened to confirm eligibility

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