Migraine Clinical Trial
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 Episodic Migraine in an at Home Setting.
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 dose of the Mi-Helper device for the acute treatment of episodic migraine in adults. Adults aged 18 years to 65 years old with a diagnosis of episodic migraine (with or without aura) for at least one year (self-reported) will be recruited for this study.
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