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Study identifier: NCT04114539 Synced from ClinicalTrials.gov · August 08, 2026
● Study status: Completed

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

Condition: Tourette Syndrome in Children · Tourette Syndrome in Adolescence  ·  Sponsor: Emalex Biosciences Inc.

PhasePhase 2
Planned participants124
Who can joinAll sexes, 6 Years to 18 Years
Healthy volunteersNoCheck eligibility criteria ↓
Where65 locations · 5 countries

Sponsor, CRO or site team? See where this study is running → — listed sites, countries and recruiting context. Everything below is written for patients and caregivers.

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

No contact information is available for this study as per the public registry record.

Always discuss trial participation with your own doctor first.

Full eligibility criteria (exactly as the study team wrote them)

Inclusion Criteria: * Subjects must have completed the EBS-101-CL-001 study through the Day 14 Follow Up Visit within the last 30 days (or longer with permission of the medical monitor) without a major reportable protocol deviation and must be someone the Investigator feels would benefit from continued participation. 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. * Positive urine drug screen. * Certain medications that would lead to drug interactions.

Reproduced word-for-word from the public registry record — the study team can answer questions about it.

Locations (65)

Harmonex Neuroscience ResearchDothan, Alabama, United States
Phoenix Children's HospitalPhoenix, Arizona, United States
Advanced Research Center Inc.Anaheim, California, United States
UCLALos Angeles, California, United States
PCSD-Feighner ResearchSan Diego, California, United States
Syrentis Clinical ResearchSanta Ana, California, United States
Yale School of MedicineNew Haven, Connecticut, United States
Sarkis Clinical TrialsGainesville, Florida, United States
Northwest Florida Clinical Research Group, LLCGulf Breeze, Florida, United States
Research in Miami Inc.Hialeah, Florida, United States
University of MiamiMiami, Florida, United States
MedBio TrialsNorth Miami, Florida, United States

+ 53 more locations — full list on the registry record.

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