CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,591 enrolled
Drug / intervention
Dihydroergotamine +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04940390
NCT04940390Phase 3Completed

A Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of STS101 (Dihydroergotamine Nasal Powder) in the Acute Treatment of Migraine

Satsuma Pharmaceuticals, Inc.·interventional·Posted Jun 25, 2021·Updated Nov 27, 2023

In Brief

A Phase 3 clinical trial evaluating Dihydroergotamine and Placebo for Migraine and 2 related conditions. Completed, enrolled 1,591 participants across 127 sites.

Detailed Summary

Study STS101-007 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20222023202420252026
First PostedJun 25, 2021
Enrollment StartJun 30, 2021
Primary CompletionOct 13, 2022
Study CompletionOct 26, 2022
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 5.0 years ago

Interventions

Dihydroergotaminedrug

Dihydroergotamine is a semi-synthetic derivative of ergotamine tartrate.

Placebodrug

Placebo for STS101