Migraine Headaches Clinical Trial
Official title:
A Randomized, Double-Blind, Cross-Over, Placebo-Controlled Study to Determine the Efficacy and Safety of ELS-M11 in Acute Migraine
This is a Phase 1/ Phase 2, 12-week, multi-center, randomized, double-blind, cross-over,
placebo-controlled study to evaluate the efficacy and safety of ELS-M11 compared to placebo
in 50 male and female subjects, aged 18 to 65 years that suffer recurring moderate-severe
migraine headaches (2-8 per month).
This study is designed to describe the efficacy and safety of ELS-M11 as compared to placebo.
Achelios is developing ELS-M11 for topical application for the acute treatment of migraine
events in patients with a history of migraine with or without aura.
To be eligible for the study, patients must have a one-year documented history of migraine
headache (as defined by the International Headache Society IHS), with or without aura, with
2≤8 moderate or severe migraine attacks per month in the 2 months prior to the screening
visit.
The total duration of the study is the completion of five migraine headaches per subject over
a maximum 12 week period followed by a 3-14 day Follow-Up Period.
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