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

NCT02057315 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2017-07-11

No results posted yet for this study

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.

Conditions

  • Migraine Headaches

Interventions

DRUG

ELS-M11

One dose of 5% ELS-M11 over 3 bilateral applications.

DRUG

Placebo

One dose of matching placebo over 3 bilateral applications.

Sponsors & Collaborators

  • Achelios Therapeutics

    lead INDUSTRY

Principal Investigators

  • Crist J. Frangakis, Ph.D. · Achelios Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2014-11-30
Completion
2014-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02057315 on ClinicalTrials.gov