Trials / Completed
CompletedNCT03901482
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate STS101 in the Acute Treatment of Migraine
EMERGE: A Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Single Doses of STS101 (Dihydroergotamine Nasal Powder) in the Acute Treatment of Migraine
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,201 (actual)
- Sponsor
- Satsuma Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
Study STS101-002 is a randomized, double-blind, parallel group, placebo-controlled, multicenter study to evaluate the efficacy, safety, and tolerability of single doses of STS101 (dihydroergotamine nasal powder) in the acute treatment of migraine
Detailed description
The EMERGE trial is a multi-center, single-dose, randomized, double-blind, placebo-controlled, parallel group study in subjects with acute migraine (ages 18 to 65 years).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Dihydroergotamine | Dihydroergotamine is a semi-synthetic derivative of ergotamine tartrate. |
| DRUG | Placebos | Placebo for STS101 |
Timeline
- Start date
- 2019-06-24
- Primary completion
- 2020-07-31
- Completion
- 2020-08-13
- First posted
- 2019-04-03
- Last updated
- 2023-06-29
- Results posted
- 2023-06-29
Locations
117 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03901482. Inclusion in this directory is not an endorsement.