NCT04940390

A Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study to Assess STS101 in the Acute Treatment of Migraine

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,591 (actual)
• Sponsor: Satsuma Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Study STS101-007 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

• Migraine
• Migraine With Aura
• Migraine Without Aura

Interventions

Type	Name	Description
DRUG	Dihydroergotamine	Dihydroergotamine is a semi-synthetic derivative of ergotamine tartrate.
DRUG	Placebo	Placebo for STS101

Timeline

• Start date: 2021-06-30
• Primary completion: 2022-10-13
• Completion: 2022-10-26
• First posted: 2021-06-25
• Last updated: 2023-11-27
• Results posted: 2023-07-24

Locations

127 sites across 1 country: United States

Regulatory

• FDA-regulated drug study