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NCT02057315 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Migraine Headaches, sponsored by Achelios Therapeutics.

Completed
Registry status
Phase 1
Development phase
48
Enrollment target
2
Study locations

NCT02057315 is a Phase 1 study of Migraine Headaches that has completed, run by Achelios Therapeutics. The registered enrollment target is 48 participants, below the 124-participant average among 4 other Migraine Headaches trials with a reported enrollment target (61% lower). The trial reports 2 study locations across 2 states.

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The verdict

NCT02057315, a Phase 1 study of Migraine Headaches, has completed, sponsored by Achelios Therapeutics.

COMPLETED
Registry status
Phase 1
Development phase
48 participants
Enrollment target
2
Study locations

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 Studied

Interventions

  • DRUG Placebo
  • DRUG ELS-M11

Study Locations (2)

Michigan

  • Michigan Head Pain and Neurological Institute - Ann Arbor

South Carolina

  • Coastal Carolina Research Center - Charleston

Trial Details

FieldValue
Enrollment Target 48 participants
Start Date 2014-03
Est. Completion 2014-11
Phase Phase 1

Sponsor

Achelios Therapeutics

1 total trials

What the Registry Record Tells You About NCT02057315

The ClinicalTrials.gov registry entry for NCT02057315 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 124-participant average among 4 other Migraine Headaches trials with a reported enrollment target (61% lower). The listed sponsor is Achelios Therapeutics, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Migraine Headaches appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT02057315 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Michigan, South Carolina.

Frequently Asked Questions

What is clinical trial NCT02057315 about?

NCT02057315 is a clinical study titled "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 m...

What is the current status of trial NCT02057315?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2014-03. Estimated completion is 2014-11.

What conditions does trial NCT02057315 study?

This clinical trial studies the following conditions: Migraine Headaches.

What interventions are being tested in trial NCT02057315?

The interventions under investigation include: Placebo (DRUG), ELS-M11 (DRUG).

Who is sponsoring clinical trial NCT02057315?

This trial is sponsored by Achelios Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02057315 being conducted?

This trial has 2 study locations across Michigan, South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.