12 completed, 1 active not recruiting, 1 terminated, 1 unknown. 8 Phase 2, 7 Phase 1, 3 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 8 | Completed 7, Unknown 1 |
| Phase 1 | 7 | Completed 7 |
| Phase 3 | 3 | Active not recruiting 1, Terminated 1, Unknown 1 |
Follow ecopipam: new trials by email Literature Review of ecopipam trials Research Report on ecopipam
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 |
| 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 |
| 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 |
| Treatment of Restless Leg Syndrome (RLS) Augmentation With Ecopipam, a D1 Specific Antagonist Ecopipam, Placebo - Restless Legs Syndrome, Augmentation | Phase 1 / Phase 2 | Completed | William Ondo, MD | 10 | 2017-09-18 | 2026-04-27 |
| Efficacy and Tolerability of Ecopipam in Adults With Childhood Onset Fluency Disorder (Stuttering). Ecopipam 50mg, Ecopipam 100mg - Stuttering, Adult, Childhood-onset Fluency Disorder | Phase 2 / Phase 3 | Unknown | Gerald Maguire, MD | 10 | 2016-09-01 | 2016-10-26 |
| 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 |
| Ecopipam Treatment of Tourette Syndrome Ecopipam - Tourette's Syndrome | Phase 1 / Phase 2 | Completed | Psyadon Pharma | 18 | 2010-10-01 | 2015-09-29 |
| 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 |
| Safety and Tolerability of the D1 Dopamine Receptor Antagonist Ecopipam in Patients With Lesch-Nyhan Disease Ecopipam - Lesch-Nyhan Disease | Phase 1 | Completed | Psyadon Pharma | 5 | 2010-02-01 | 2013-04-18 |
Tourette Syndrome (5) · Childhood-Onset Fluency Disorder (2) · Communication Disorders (2) · Lesch-Nyhan Syndrome (2) · Self-Injurious Behavior (2) · Stuttering (2) · Brain Diseases (1) · Central Nervous System Diseases (1) · Gambling (1) · Language Disorders (1) · Mental Disorders (1) · Movement Disorders (1) · Nervous System Diseases (1) · Neurodegenerative Diseases (1) · Neurodevelopmental Disorders (1)
Emalex Biosciences Inc. (11) · Psyadon Pharma (2) · Gerald Maguire, MD (1) · William Ondo, MD (1)
United States (14) · Canada (4) · Poland (3) · France (2) · Germany (2) · Spain (2) · Bulgaria (1) · Hungary (1) · Italy (1) · Serbia (1)
Donald Gilbert, MD (2) · Atul R Mahableshwarkar, MD, DFAPA (1) · Donald Black, MD (1) · Frederick Munschauer, MSc, MD, FAAN (1) · H J Jinnah, MD (1) · Hyder A Jinnah, MD (1) · Jon Grant, MD (1) · Marc Potenza, MD (1) · Mohamed Al-Ibrahim, MB,ChB,FACP (1) · Rick Munschauer, MSc, MD, FAAN (1) · Timothy Fong, MD (1) · William G. Ondo, MD (1) · William L Nyhan, MD (1)
PMID 10917410, PMID 12849360, PMID 15026214, PMID 15212606, PMID 15328899, PMID 20075648, PMID 24434529, PMID 25166480, PMID 30192018
2023 (1)