12 completed, 3 withdrawn, 2 terminated, 1 active not recruiting. 11 Phase 2, 6 Phase 1, 2 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 11 | Completed 7, Terminated 2, Withdrawn 2 |
| Phase 1 | 6 | Completed 3, Active not recruiting 1, Not yet recruiting 1, Withdrawn 1 |
| Phase 3 | 2 | Completed 2 |
Follow Midomafetamine HCl: new trials by email Literature Review of Midomafetamine HCl trials Research Report on Midomafetamine HCl
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 |
|---|---|---|---|---|---|---|
| Study of Midomafetamine in Healthy Adults Midomafetamine HCl - Healthy Volunteers | Phase 1 | Active not recruiting | Resilient Pharmaceuticals | 32 | 2026-04-23 | 2026-06-29 |
| MDMA in Subjects With Moderate Hepatic Impairment and Subjects With Normal Hepatic Function Midomafetamine HCl - Pharmacokinetics, Hepatic Impairment | Phase 1 | Not yet recruiting | Resilient Pharmaceuticals | 16 | 2026-03-29 | 2024-10-30 |
| A Multi-Site Study of MDMA-Assisted Psychotherapy for Eating Disorders Midomafetamine, Non-directive therapy, Therapy - Anorexia Nervosa Restricting Type, Binge-Eating Disorder | Phase 2 | Withdrawn | Resilient Pharmaceuticals | 2026-02-01 | 2024-10-31 | |
| Psychological Effects of Methylenedioxymethamphetamine (MDMA) When Administered to Healthy Volunteers (MT-2) Midomafetamine HCl, Therapy - Psychological Effects of Study Drug | Phase 1 | Withdrawn | Resilient Pharmaceuticals | 2024-12-01 | 2024-10-31 | |
| Study of Safety and Effects of MDMA-assisted Therapy for Treatment of PTSD midomafetamine, Therapy - Posttraumatic Stress Disorder | Phase 2 | Withdrawn | Resilient Pharmaceuticals | 2022-08-01 | 2024-11-01 | |
| Food Effects on Bioavailability of MDMA in Healthy Volunteers midomafetamine - Pharmacokinetics | Phase 1 | Completed | Resilient Pharmaceuticals | 14 | 2022-07-28 | 2024-10-30 |
| Study Comparing Two Versus Three Active MDMA-assisted Sessions in U.S. Military Veterans With Chronic PTSD Midomafetamine, Psychotherapy - PTSD | Phase 2 | Terminated | Resilient Pharmaceuticals | 26 | 2021-11-08 | 2025-07-15 |
| A Multi-Site Open-Label Extension Study of MDMA-Assisted Psychotherapy for PTSD Midomafetamine HCl - PTSD | Phase 3 | Completed | Resilient Pharmaceuticals | 87 | 2021-03-08 | 2025-06-06 |
| Open Label Study of MDMA-assisted Psychotherapy for Treatment of PTSD With Optional fMRI Sub-Study Midomafetamine HCl - PTSD | Phase 2 | Completed | MAPS Europe B.V. | 21 | 2020-06-24 | 2025-01-28 |
| A Multi-Site Phase 3 Study of MDMA-Assisted Psychotherapy for PTSD (MAPP1) Therapy, midomafetamine HCl, Placebo - Posttraumatic Stress Disorder | Phase 3 | Completed | Resilient Pharmaceuticals | 100 | 2018-11-21 | 2025-06-06 |
| Study of Safety and Effects of MDMA-assisted Psychotherapy for Treatment of PTSD (Canada) Midomafetamine HCl, Manualized therapy - Posttraumatic Stress Disorder | Phase 2 | Completed | Resilient Pharmaceuticals | 4 | 2018-03-13 | 2025-06-10 |
| Evaluation of MDMA on Startle Response Placebo, Midomafetamine, Acoustic startle - Startle Response | Phase 1 | Completed | Resilient Pharmaceuticals | 34 | 2017-03-14 | 2025-03-04 |
| MDMA-Assisted Psychotherapy for Anxiety Associated With a Life-Threatening Illness Midomafetamine HCl, Placebo, Therapy - Anxiety | Phase 2 | Completed | Resilient Pharmaceuticals | 18 | 2015-05-14 | 2025-06-05 |
| Randomized, Double-blind, Controlled of MDMA-assisted Psychotherapy in 12 Subjects With PTSD Placebo, Midomafetamine HCl, Psychotherapy - Posttraumatic Stress Disorder | Phase 2 | Terminated | Resilient Pharmaceuticals | 6 | 2014-10-14 | 2025-06-05 |
| Phase 2 Pilot Safety Study of MDMA-assisted Therapy for Social Anxiety in Autistic Adults Placebo, Midomafetamine HCl, Therapy - Social Anxiety in Autistic Adults | Phase 2 | Completed | Resilient Pharmaceuticals | 12 | 2014-04-11 | 2025-06-05 |
| Dose-Response Study of MDMA-assisted Psychotherapy in People With PTSD Comparator Dose (40mg) MDMA HCl, Active Dose 2 (100 mg) MDMA HCl, Active Dose 1 (125 mg) MDMA HCl - Posttraumatic Stress Disorder | Phase 2 | Completed | Resilient Pharmaceuticals | 29 | 2013-05-13 | 2025-06-05 |
| Randomized, Double-blind, Placebo-Controlled Pilot Study of MDMA-assisted Therapy for PTSD Active Placebo Dose MDMA-assisted therapy (25 mg), Full Dose MDMA-assisted therapy (125 mg), Open-Label Full Dose MDMA-assisted therapy (125 mg) - Posttraumatic Stress Disorder (PTSD) | Phase 2 | Completed | Resilient Pharmaceuticals | 10 | 2013-01-17 | 2025-06-06 |
| Psychological Effects of Methylenedioxymethamphetamine (MDMA) When Administered to Healthy Volunteers Lactose (inactive placebo), midomafetamine HCl - Psychological Effects of Study Drug | Phase 1 | Completed | Resilient Pharmaceuticals | 107 | 2011-04-09 | 2024-10-31 |
| MDMA-Assisted Psychotherapy in People With Posttraumatic Stress Disorder Midomafetamine HCl, Lactose placebo pill, Therapy - Posttraumatic Stress Disorder | Phase 2 | Completed | Resilient Pharmaceuticals | 23 | 2004-03-12 | 2025-06-06 |
| A Multi-site Expanded Access Program for MDMA-assisted Psychotherapy for Patients With Treatment-resistant PTSD Midomafetamine, Psychotherapy - Post Traumatic Stress Disorder | No longer available | Resilient Pharmaceuticals | 2024-11-05 |
Stress Disorders, Post-Traumatic (11) · Anxiety Disorders (1) · Autistic Disorder (1) · Binge-Eating Disorder (1) · Depression (1)
Resilient Pharmaceuticals (19) · MAPS Europe B.V. (1)
United States (13) · Canada (4) · Israel (3) · Czechia (1) · Germany (1) · Netherlands (1) · Norway (1) · United Kingdom (1)
Adele Lafrance, PhD (1) · Barbara Rothbaum (1) · Bessel van der Kolk, MD (1) · Caroline Lewis, MD (1) · Casey Paleos, MD (1) · Charles S. Grob, MD (1) · Cole Marta, MD (1) · Devon Christie, MD (1) · Emma Hapke, MD (1) · Ingrid Pacey, MBBS FRCP[C] (1) · Janel Long-Boyle, PharmD, PhD (1) · Josh Woolley, MD, PhD (1) · Manish Agrawal, MD (1) · Marcela Ot'alora (1)
PMID 31065731, PMID 31572236, PMID 32500209, PMID 20643699, PMID 23172889, PMID 25818246, PMID 30196397, PMID 33235285, PMID 33972795, PMID 35166140, PMID 38174611, PMID 38198456