Ecopipam for Tourette Syndrome
(D1AMOND Trial)

Recruiting in Palo Alto (17 mi)

+107 other locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Emalex Biosciences Inc.

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial tests ecopipam tablets in people with Tourette's Disorder. The medication aims to reduce tics by blocking certain brain signals. Ecopipam is being tested for its safety and tic-reducing activity in adults with Tourette syndrome.

Research Team

Eligibility Criteria

This trial is for children, adolescents, and adults with Tourette's Disorder who weigh at least 40 lbs and have a significant number of tics. Participants must not be on tic medications for two weeks before the study starts and should use effective contraception if sexually active.

Inclusion Criteria

I am 6 years old or older.

I weigh at least 40 pounds.

Minimum score of 20 on the YGTSS-R Total Tic Score

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Exclusion Criteria

You are currently pregnant or breastfeeding.

You have a high risk of harming yourself.

My medication doses for anxiety, depression, or ADHD are stable.

See 4 more

Treatment Details

Interventions

Ecopipam Hydrochloride (Dopamine D1 Receptor Antagonist)

Trial OverviewThe study tests ecopipam tablets to see if they help maintain control over tics in people with Tourette's. It starts with an open phase where everyone gets the drug, followed by a random phase where half get ecopipam and half get a placebo without knowing which one they're taking.

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: 1.8 mg/kg/day ecopipam (2 mg/kg/day ecopipam HCl)Experimental Treatment1 Intervention

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.

Group II: Placebo during R/WD PhasePlacebo Group1 Intervention

Matching Placebo tablets during R/WD period taken orally in the evening.