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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

ClinicalTrials.gov · COMPLETED, 2020

1,201 participants

Abstract

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

Conditions: Migraine, Migraine With Aura, Migraine Without Aura.

Primary outcome: Percentage of Subjects With Freedom From Migraine Headache Pain at 2 Hours Post Dose; Percentage of Subjects With Freedom From Most-Bothersome Symptom at 2 Hours Post Dose.

Enrollment: 1201 participants.

How strong is the evidence?

Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 1,201 participants or records.

How the five levels of evidence work. The level is assigned automatically from the abstract and can be wrong, so check the paper.

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