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Study to Determine the Efficacy and Safety of ELS-M11 in Acute Migraine
NCT02057315 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Achelios Therapeutics, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02057315 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Michigan, South Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02057315?
The interventions under investigation include: Placebo (DRUG), ELS-M11 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02057315?
This trial is sponsored by Achelios Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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