CompletedPhase 2

Ecopipam Treatment of Tourette's Syndrome in Subjects 7-17 Years

United States40 participantsStarted 2014-06-19

Plain-language summary

Tourette's Syndrome is a neurological disease characterized by motor and vocal tics. It has been hypothesized that abnormal interactions of dopamine with its receptors may cause the tics. The purpose of this study is to test the hypothesis that a drug (ecopipam) that selectively blocks dopamine D1/D5 receptors can reduce the frequency and severity of the tics.

Who can participate

Age range

7 Years – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria:• Subjects must have Tourette's Syndrome (TS) based on the clinician-administered Diagnostic Confidence Index (DCI) for TS. * Subjects must exhibit both motor and vocal tics. * Subjects must have a minimum score of 20 at both Screening and Baseline (just prior to the first treatment) on the Yale Global Tic Severity Scale. * Subjects must be age (≥ 7 to \< 18 years of age) * Subjects must weigh ≥ 20 kg (45 lbs) * Adolescent females of childbearing potential who are sexually active must be using effective contraception (i.e., oral contraceptives, intrauterine device, double barrier method of condom and spermicide) and agree to continue use of contraception for the duration of their participation in the study. They must also agree to use contraception for 30 days after their last dose of study drug. * Sexually active male subjects must use a barrier method of contraception during the study and agree to continue the use of male contraception for at least 30 days after the last dose of study drug. * Subject's parent or legal guardian must execute a written informed consent. * Subject must execute a written informed assent. Exclusion Criteria: * Subjects who have unstable medical illness or clinically significant abnormalities on laboratory tests, or ECG at Screening. * Subjects with a major depressive episode in the past 2 years * Subjects with a history of attempted suicide * Subjects with clinically significant suicidality (based on the Columbia Suicide Rat…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Yale Global Tic Severity Scale - Total Tic Score

Timeframe: Baseline and 30 days

Trial details

NCT IDNCT02102698

SponsorEmalex Biosciences Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-12

Results submitted2025-06-15

View on ClinicalTrials.gov More Tourette's Syndrome trials