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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.
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
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2014-03 |
| Est. Completion | 2014-11 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗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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Read our methodology - how this data is sourced, computed, and verified.
Related
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