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First received: September 18, 2023

Clinical Trial: Mi-Helper Transnasal Cooling for Acute Treatment of Migraine

Study Status: Completed

Recruit Status: RECRUITING

Condition: Episodic Migraine

Study Type: INTERVENTIONAL


Official Title: A Prospective, Double-blind, Sham-controlled, Randomized Two-part Adaptive Clinical Trial to Assess the Safety, Efficacy, Tolerability, and Optimal Dose of the Mi-Helper Device for Acute Treatment of

Brief Summary: This is a prospective, double-blind, sham-controlled, randomized two-part clinical trial with an adaptive design.This study aims to assess the efficacy, safety, tolerability, and the optimal dose of the Mi-Helper transnasal cooling device for acute treatment of migraine in an at home setting.This study will be conducted in two parts.The first part of this study aims to determine the most effective dose of Mi-Helper and the second part aims to evaluate the efficacy, safety, and tolerability of the most effective…

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