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NCT04114539 · ClinicalTrials.gov registry record · Phase 2

Ecopipam Tablets to Study Tourette Syndrome in Children and Adolescents - Open Label Extension

A Phase 2 study, sponsored by Emalex Biosciences.

Completed
Registry status
Phase 2
Development phase
124
Enrollment target

NCT04114539: Completed Phase 2 study, sponsored by Emalex Biosciences.

NCT04114539 is a Phase 2 study that has completed, run by Emalex Biosciences. The registered enrollment target is 124 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04114539, a Phase 2 study, has completed, sponsored by Emalex Biosciences.

COMPLETED
Registry status
Phase 2
Development phase
124 participants
Enrollment target

Study Summary

This study was 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.

Primary Outcome

An AE was any untoward medical condition that occurs in a participant while participating in this clinical study. It can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not related to the study. An SAE was any untoward medical occurrence that at any dose met one, more of the following criteria: results in death, life-threatening, requires inpatient hospitalization or prolongation

Interventions

  • DRUG Ecopipam

Trial Details

FieldValue
Enrollment Target 124 participants
Start Date 2019-10-04
Est. Completion 2022-11-11
Phase Phase 2
Emalex Biosciences

14 total trials

What the finished NCT04114539 record still lists

NCT04114539 is an interventional study that assigns participants to a tested intervention. The registered 124 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.

The record links to 0 conditions, and to 1 intervention - of which Ecopipam is the first listed.

NCT04114539 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04114539 about?

NCT04114539 is a clinical study titled "Ecopipam Tablets to Study Tourette Syndrome in Children and Adolescents - Open Label Extension". This study was 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.

What is the current status of trial NCT04114539?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 124 participants. The study started on 2019-10-04. Estimated completion is 2022-11-11.

What interventions are being tested in trial NCT04114539?

The interventions under investigation include: Ecopipam (DRUG).

Who is sponsoring clinical trial NCT04114539?

This trial is sponsored by Emalex Biosciences, which has 14 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04114539's enrollment target sits among peer trials

124 564th of 2000 higher than 1,437 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04114539, the US trial registry maintained by the National Library of Medicine. NCT04114539 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.