14 completed, 1 terminated. 8 Phase 1, 4 Phase 3, 2 Phase 2, 1 Not applicable, 1 Phase 4.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 8 | Completed 8 |
| Phase 3 | 4 | Completed 4 |
| Phase 2 | 2 | Completed 1, Terminated 1 |
| Not applicable | 1 | Completed 1 |
| Phase 4 | 1 | Completed 1 |
Follow Dihydroergotamine: new trials by email Literature Review of Dihydroergotamine trials Research Report on Dihydroergotamine
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 |
|---|---|---|---|---|---|---|
| A Study Evaluating the Safety, Tolerability and Pharmacokinetics of ASY202 in Healthy Adults DHE inhalation powder low dose administered via dry powder inhaler (DPI) device, DHE inhalation powder high dose administered via dry powder inhaler (DPI) device, DHE injected intravenously (1 mg) - Safety, and Tolerability | Phase 1 | Completed | Aspeya Switzerland SA | 44 | 2025-06-09 | 2026-03-19 |
| A Study to Assess the Safety, Tolerability, and Pharmacokinetics of PUR3100 in Health Adults PUR3100, Dihydroergotamine (D.H.E 45), Matching Placebo for PUR3100 - Healthy | Phase 1 | Completed | Pulmatrix Inc. | 26 | 2022-06-09 | 2022-12-23 |
| A Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study to Assess STS101 in the Acute Treatment of Migraine Dihydroergotamine, Placebo - Migraine, Migraine With Aura | Phase 3 | Completed | Satsuma Pharmaceuticals, Inc. | 1591 | 2021-06-30 | 2023-11-27 |
| A Study of the PK and Safety of Single Doses of STS101, DHE Injection and Nasal Spray in Healthy Subjects Dihydroergotamine - Migraine, Migraine With Aura | Phase 1 | Completed | Satsuma Pharmaceuticals, Inc. | 36 | 2021-03-05 | 2022-04-20 |
| A Study to Evaluate the Safety of STS101 in the Acute Treatment of Migraine Dihydroergotamine - Migraine, Migraine With Aura | Phase 3 | Completed | Satsuma Pharmaceuticals, Inc. | 482 | 2020-09-14 | 2023-07-03 |
| A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate STS101 in the Acute Treatment of Migraine Dihydroergotamine, Placebos - Migraine, Migraine With Aura | Phase 3 | Completed | Satsuma Pharmaceuticals, Inc. | 1201 | 2019-06-24 | 2023-06-29 |
| A Phase I Study to Study the PK and Safety of Single Doses of STS101, DHE Injection and Nasal Spray in Healthy Subjects Dihydroergotamine - Migraine With Aura, Migraine Without Aura | Phase 1 | Completed | Satsuma Pharmaceuticals, Inc. | 46 | 2018-09-11 | 2019-11-26 |
| Safety and Tolerability of POD-DHE (INP104) in Migraine (STOP 301) INP104 - Migraine Headache | Phase 3 | Completed | Impel Pharmaceuticals | 360 | 2018-07-13 | 2021-03-11 |
| Bioavailability of DHE Administered by I123 POD Device, IV Injection, and Migranal Nasal Spray in Healthy Adults INP104, Dihydroergotamine Mesylate (DHE), Migranal Nasal Spray - Migraine Headache | Phase 1 | Completed | Impel Pharmaceuticals | 36 | 2017-10-19 | 2019-03-15 |
| Valproic Acid and Dihydroergotamine as Abortive Therapy in Pediatric Migraine Valproic Acid (VPA), Dihydroergotamine (DHE) - Migraine in Children | Phase 2 | Terminated | Kimberly S Jones | 24 | 2017-10-03 | 2021-10-07 |
| Pharmacokinetics & Tolerability Study of MAP0004 Co-administered With Ketoconazole MAP0004, IV DHE, Ketoconazole - Healthy | Phase 1 | Completed | Allergan | 24 | 2010-07-01 | 2014-01-09 |
| Pharmacodynamic Study to Compare Acute Effects of Dihydroergotamine Mesylate (DHE) on Pulmonary Arterial Pressure MAP0004, IV Placebo (Saline), Placebo Inhaler - Healthy | Phase 1 | Completed | Allergan | 24 | 2010-03-01 | 2014-01-09 |
| Pharmacokinetics & Tolerability Study of MAP0004 in Smoking and Non-Smoking Adult Volunteers MAP0004, IV DHE - Healthy Subjects | Phase 1 / Phase 2 | Completed | Allergan | 47 | 2010-01-01 | 2014-01-09 |
| A Research Study Examining Migranal and Skin Sensitivity in Subjects With Migraine Migranal nasal spray at 1 hour, Migranal nasal spray at 4 hour - Migraine | Phase 4 | Completed | Thomas Jefferson University | 64 | 2006-08-01 | 2022-03-11 |
| A Study Examining the Use of a Migraine Medicine in the Treatment of Two Migraine Attacks in Patients Who Have Increased Skin Sensitivity dihydroergotamine mesylate - Migraine | Not applicable | Completed | Thomas Jefferson University | 13 | 2003-12-01 | 2014-06-09 |
Migraine Disorders (10) · Migraine with Aura (5) · Migraine without Aura (5) · Headache (1)
Satsuma Pharmaceuticals, Inc. (5) · Allergan (3) · Impel Pharmaceuticals (2) · Thomas Jefferson University (2) · Aspeya Switzerland SA (1) · Kimberly S Jones (1) · Pulmatrix Inc. (1)
United States (11) · Australia (2) · United Kingdom (2)
Detlef Albrecht, MD (3) · Jason Lickliter, MD (1) · Jeffrey A Levy, MD, PhD (1) · Jeffrey Levy, MD (1) · Robert J Noveck, M.D., Ph.D. (1) · Stephen D Silberstein, MD (1) · Stephen D. Silberstein, M.D. (1)
PMID 22174351, PMID 23926420, PMID 30659611, PMID 31985049, PMID 38413540, PMID 39373843, PMID 41186275