Dihydroergotamine
- Generic Name
- Dihydroergotamine
- Brand Names
- Dhe-45, Migranal, Trudhesa
- Drug Type
- Small Molecule
- Chemical Formula
- C33H37N5O5
- CAS Number
- 511-12-6
- Unique Ingredient Identifier
- 436O5HM03C
- Background
A 9,10alpha-dihydro derivative of ergotamine. Dihydroergotamine is used as an abortive therapy for migraines. Its use has largely been supplanted by triptans in current therapy due to the class's greater selectivity and more favourable side effect profile.
Recent improvements have been made in the design of intranasal delivery devices allowing for greater delivery of dihydroergotamine solution to the vasculature-rich upper nasal cavity. The recently approved Precision Olfactory Delivery technology developed by Impel Neuropharma technology has correlated with an increase of 3-fold in Cmax and 4-fold in AUC despite the solution formulated at 75% of the strength of the existing intranasal product.
- Indication
Dihydroergotamine (DHE) in all formulations is indicated for the acute treatment of migraine with or without aura in adults. As an injection, DHE is also indicated for the acute treatment of cluster headache episodes.
DHE is not indicated for migraine prevention or the management of hemiplegic or basilar migraine.
- Associated Conditions
- Cluster Headache, Migraine Headache, With or Without Aura
- Associated Therapies
- -
A Study of the PK and Safety of Single Doses of STS101, DHE Injection and Nasal Spray in Healthy Subjects
- Conditions
- Migraine Without AuraMigraine With AuraMigraine
- Interventions
- First Posted Date
- 2022-04-20
- Last Posted Date
- 2022-04-20
- Lead Sponsor
- Satsuma Pharmaceuticals, Inc.
- Target Recruit Count
- 36
- Registration Number
- NCT05337254
- Locations
- 🇺🇸
Quotient Sciences Miami Inc., Miami, Florida, United States
A Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study to Assess STS101 in the Acute Treatment of Migraine
- Conditions
- Migraine With AuraMigraine Without AuraMigraine
- Interventions
- Drug: DihydroergotamineDrug: Placebo
- First Posted Date
- 2021-06-25
- Last Posted Date
- 2023-11-27
- Lead Sponsor
- Satsuma Pharmaceuticals, Inc.
- Target Recruit Count
- 1591
- Registration Number
- NCT04940390
- Locations
- 🇺🇸
DM Clinical Research, Tomball, Texas, United States
🇺🇸Downtown LA Research Center, Los Angeles, California, United States
🇺🇸Palm Beach Research, West Palm Beach, Florida, United States
A Study to Evaluate the Safety of STS101 in the Acute Treatment of Migraine
- Conditions
- MigraineMigraine With AuraMigraine Without Aura
- Interventions
- First Posted Date
- 2020-05-28
- Last Posted Date
- 2023-07-03
- Lead Sponsor
- Satsuma Pharmaceuticals, Inc.
- Target Recruit Count
- 482
- Registration Number
- NCT04406649
- Locations
- 🇺🇸
ClinCloud, Maitland, Florida, United States
🇺🇸CNS Health Care - Orlando, Orlando, Florida, United States
🇺🇸Advanced Clinical Research, Meridian, Idaho, United States
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate STS101 in the Acute Treatment of Migraine
- Conditions
- MigraineMigraine With AuraMigraine Without Aura
- Interventions
- Drug: PlacebosDrug: Dihydroergotamine
- First Posted Date
- 2019-04-03
- Last Posted Date
- 2023-06-29
- Lead Sponsor
- Satsuma Pharmaceuticals, Inc.
- Target Recruit Count
- 1201
- Registration Number
- NCT03901482
- Locations
- 🇺🇸
Thomas Jefferson University/Jefferson Headache Center, Philadelphia, Pennsylvania, United States
🇺🇸Cal Neuro Research Group, Los Angeles, California, United States
🇺🇸Rapid Medical Research Inc., Cleveland, Ohio, United States
A Phase I Study to Study the PK and Safety of Single Doses of STS101, DHE Injection and Nasal Spray in Healthy Subjects
- Conditions
- MigraineMigraine With AuraMigraine Without Aura
- Interventions
- First Posted Date
- 2019-03-14
- Last Posted Date
- 2019-11-26
- Lead Sponsor
- Satsuma Pharmaceuticals, Inc.
- Target Recruit Count
- 46
- Registration Number
- NCT03874832
- Locations
- 🇺🇸
Quotient Sciences Miami Inc., Miami, Florida, United States
Drug Development Updates
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