drugset / Trial / NCT02057315

Study to Determine the Efficacy and Safety of ELS-M11 in Acute Migraine

NCT02057315 ↗

Phase 1/2 Completed 48 enrolled Achelios Therapeutics
RandomizedCrossoverQuadruple-blindTreatment

Summary

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.

Timeline

Start
2014-03
Primary completion
2014-11
Completion
2014-11

Drugs

EvaluationDrugModalityDoseRoute
Subject ELS-M11 Unknown 5 % Topical
Subject ELS-M11 Unknown 3 g Topical

Indications