A Phase 1/2 interventional study of ELS-M11 and Placebo in Migraine Headaches, sponsored by Achelios Therapeutics. Completed at 2 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-07-11.
Sponsored by Achelios Therapeutics · Phase 1/2, Interventional, and Treatment
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.
Achelios is developing ELS-M11 for topical application for the acute treatment of migraine events in patients with a history of migraine with or without aura.
To be eligible for the study, patients must have a one-year documented history of migraine headache (as defined by the International Headache Society IHS), with or without aura, with 2≤8 moderate or severe migraine attacks per month in the 2 months prior to the screening visit.
The total duration of the study is the completion of five migraine headaches per subject over a maximum 12 week period followed by a 3-14 day Follow-Up Period.
1,558 studies on the registry are indexed under Migraine Disorders; 301 are open to participants now.
This study's enrollment of 48 is below the median of 80 across 1,197 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →This is the only study on the registry with Achelios Therapeutics as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Topical 5% ELS-M11 (3 g)
Drug: ELS-M11 · Drug: Placebo
A matching formulation with no active ingredient
Drug: ELS-M11 · Drug: Placebo
One dose of 5% ELS-M11 over 3 bilateral applications.
Also known as: Topofen (ketoprofen) Gel 5%
One dose of matching placebo over 3 bilateral applications.
Percentage of patients who experience pain relief 2 hours following the first application of ELS-M11
Pain relief (as defined by a one point decrease on a 4 point pain intensity scale) in subjects experiencing a moderate to severe migraine headache, 2 hours after the initial application of ELS-M11.
Time frame: 2 hours
Percentage of patients who report pain relief at various time points within a 24 hour period, following the first application of ELS-M11
Pain relief (as defined by a one point decrease on a 0-3 point pain intensity scale) in subjects experiencing a moderate to severe migraine headache over a 24 hour period following the first application of ELS-M11.
Time frame: 24 hours
Percentage of patients who report complete pain resolution within 24 hours following the first application of ELS-M11.
Complete resolution (intensity score of 0 on a 0-3 pain scale) of migraine pain within 24 hours, following ELS-M11 application in subjects experiencing a moderate to severe migraine headache.
Time frame: 24 hours
Percentage of patients who report sustained pain relief after the first application of ELS-M11
Sustained pain relief defined as pain relief by 2 hours post study medication application with no increase in the pain intensity score up to 24 hours post medication application in moderate and severe headaches, following ELS-M11 application.
Time frame: 24 hours
Percentage of patients who report sustained complete pain resolution after the first application of ELS-M11.
Sustained complete pain resolution defined as pain free by 2 hours post study medication application with no change in a pain intensity score of 0 up to 24 hours post medication application in moderate and severe headaches, following ELS-M11 application.
Time frame: 24 hours
Time to Initial Use of Rescue Medication following the first application of ELS-M11
Time to Initial Use of Rescue Medication following ELS-M11 application in subjects experiencing moderate to severe headaches within a 24 hour period
Time frame: 24 hours
Use of Rescue Medication following the first application of ELS-M11 by 24 hours
Use of Rescue Medication within 24 hours following ELS-M11 application in patients experiencing moderate to severe migraine headaches.
Time frame: 24 hours
Resolution of migraine-associated symptoms, following the first application of ELS-M11
Free of migraine-associated symptoms within 24 hours after ELS-M11 application in patients experiencing moderate to severe migraine headaches.
Time frame: 24 hours
Percentage of patients who can resume or maintain their normal routine, following the first application of ELS-M11.
Resuming or maintaining normal routine within 24 hours after first study medication application in moderate and severe headaches.
Time frame: 24 hours
This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.
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