13 completed, 2 terminated, 1 active not recruiting, 1 temporarily not available. 8 Phase 1, 5 Phase 2, 3 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 8 | Completed 7, Terminated 1 |
| Phase 2 | 5 | Completed 5 |
| Phase 3 | 3 | Active not recruiting 1, Completed 1, Terminated 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Food-effect Study of Ecopipam Pharmacokinetics Ecopipam tablet - Food-effect | Phase 1 | Completed | Emalex Biosciences Inc. | 25 | 2024-11-05 | 2025-01-27 |
| Drug Interaction Study Itraconazole, rifampicin, Ecopipam - Drug Interaction | Phase 1 | Completed | Emalex Biosciences Inc. | 45 | 2024-01-18 | 2024-09-19 |
| A Study to Evaluate Long-term Safety of Ecopipam Tablets in Children, Adolescents and Adults With Tourette's Disorder Ecopipam - Tourette Syndrome | Phase 3 | Active not recruiting | Emalex Biosciences Inc. | 150 | 2023-08-16 | 2026-07-22 |
| Thorough QT/QTc Study to Evaluate the Effects of Ecopipam (EBS-101) on Cardiac Repolarization Ecopipam Hydrochloride, Moxifloxacin, Placebo - QT/QTc | Phase 1 | Completed | Emalex Biosciences Inc. | 29 | 2023-03-15 | 2023-06-09 |
| Ecopipam Tablets to Study Tourette's Disorder in Children, Adolescents and Adults Ecopipam Hydrochloride - Tourette Disorder | Phase 3 | Completed | Emalex Biosciences Inc. | 216 | 2023-01-31 | 2026-06-12 |
| Drug-Drug Interaction Study to Evaluate the Effects of Ecopipam on the Pharmacokinetics of Multiple Substrates for Drug Metabolism and Transport Ecopipam, Cohort 1 Probe Substrate Cocktail, Cohort 2 Probe Substrate - Drug Interaction | Phase 1 | Completed | Emalex Biosciences Inc. | 56 | 2022-04-26 | 2022-12-12 |
| Drug-Drug Interaction Study to Evaluate the Effect of Inhibition of UGTs on the PK of Ecopipam and Its Active Metabolite ecopipam HCL, Mefenamic acid, Divalproex Sodium ER - Drug Interaction | Phase 1 | Completed | Emalex Biosciences Inc. | 38 | 2021-05-13 | 2021-07-22 |
| Study of the Absorption, Metabolism, and Excretion of [14C]-Ecopipam in Healthy Male Subjects [14C]-Ecopipam - Healthy Volunteer | Phase 1 | Completed | Emalex Biosciences Inc. | 8 | 2021-05-12 | 2021-12-03 |
| Drug-Drug Interaction Study to Evaluate the Effects of Ecopipam on the Pharmacokinetics of Multiple Substrates ecopipam HCl ~2mg/kg/day, Cohort 1 Probe Cocktail, Cohort 2 Probe Cocktail - Drug-Interactions | Phase 1 | Terminated | Emalex Biosciences Inc. | 30 | 2021-02-18 | 2021-05-24 |
| Effects of Ecopipam or Placebo in Adults With Stuttering (Speak Freely) Ecopipam, Placebo - Childhood-Onset Fluency Disorder (Stuttering) | Phase 2 | Completed | Emalex Biosciences Inc. | 68 | 2020-10-22 | 2026-09-23 |
| Ecopipam Tablets to Study Tourette Syndrome in Children and Adolescents - Open Label Extension Ecopipam - Tourette Syndrome in Children, Tourette Syndrome in Adolescence | Phase 2 | Completed | Emalex Biosciences Inc. | 124 | 2019-10-04 | 2024-02-01 |
| Ecopipam Tablets to Study Tourette's Syndrome in Children and Adolescents Ecopipam, Placebo - Tourette Syndrome | Phase 2 | Completed | Emalex Biosciences Inc. | 153 | 2019-06-28 | 2023-10-04 |
| Ecopipam Treatment of Tourette's Syndrome in Subjects 7-17 Years Ecopipam - Tourette's Syndrome | Phase 2 | Completed | Emalex Biosciences Inc. | 40 | 2014-06-19 | 2026-05-22 |
| Ecopipam Treatment of Self-Injurious Behavior in Subjects With Lesch-Nyhan Disease Ecopipam, Placebo - Lesch-Nyhan Disease, Self-injurious Behavior | Phase 3 | Terminated | Emalex Biosciences Inc. | 9 | 2012-12-01 | 2024-04-22 |
| Safety and Tolerability Comparison of Immediate and Controlled Release Formulations of Ecopipam Ecopipam immediate release form, 90 mg controlled release form, 180 mg controlled release form - Healthy | Phase 1 | Completed | Emalex Biosciences Inc. | 16 | 2011-08-01 | 2024-04-19 |
| Clinical Study to Determine if Ecopipam Can Reduce Urges to Gamble Ecopipam - Pathological Gambling | Phase 2 | Completed | Emalex Biosciences Inc. | 34 | 2010-10-01 | 2024-05-14 |
| Expanded Access Program for Treatment With Ecopipam for Tourette's Disorder ecopipam HCl ~2mg/kg/day - Tourettes Disorder, Tourette Disorder | Temporarily not available | Emalex Biosciences Inc. | 2026-10-14 |
Tourette Syndrome (6) · Brain Diseases (1) · Central Nervous System Diseases (1) · Childhood-Onset Fluency Disorder (1) · Communication Disorders (1) · Gambling (1) · Lesch-Nyhan Syndrome (1) · Mental Disorders (1) · Movement Disorders (1) · Nervous System Diseases (1) · Neurodegenerative Diseases (1) · Neurodevelopmental Disorders (1) · Self-Injurious Behavior (1) · Stuttering (1) · Tic Disorders (1)
ecopipam (11) · Itraconazole (1) · Mefenamic Acid (1) · Moxifloxacin (1) · Rifampin (1)
United States (15) · Canada (5) · Poland (4) · France (3) · Germany (3) · Spain (3) · Bulgaria (2) · Hungary (2) · Italy (2) · Serbia (2) · Denmark (1) · Romania (1) · United Kingdom (1)
Atul R Mahableshwarkar, MD, DFAPA (1) · Donald Black, MD (1) · Donald Gilbert, MD (1) · Frederick Munschauer, MSc, MD, FAAN (1) · H J Jinnah, MD (1) · Jon Grant, MD (1) · Marc Potenza, MD (1) · Mohamed Al-Ibrahim, MB,ChB,FACP (1) · Rick Munschauer, MSc, MD, FAAN (1) · Sarah Atkinson, MD (1) · Timothy Fong, MD (1)
PMID 25166480, PMID 30192018, PMID 42189524
2023 (2)