Clinical Trial: Study to Determine the Efficacy and Safety of ELS-M11 in Acute Migraine
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Randomized, Double-Blind, Cross-Over, Placebo-Controlled Study to Determine the Efficacy and Safety of ELS-M11 in Acute Migraine
Brief Summary:
This is a Phase Ib, 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.
Detailed Summary:
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.
Sponsor: Achelios Therapeutics
Current Primary Outcome: Percentage of patients who experience pain relief 2 hours following the first application of ELS-M11 [ Time Frame: 2 hours ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Percentage of patients who report pain relief at various time points within a 24 hour period, following the first application of ELS-M11 [ Time Frame: 24 hours ]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.
- Percentage of patients who report complete pain resolution within 24 hours following the first application of ELS-M11. [ Time Frame: 24 hours ]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.
- Percentage of patients who report sustained pain relief after the first application of ELS-M11 [ Time Frame: 24 hours ]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.
- Percentage of patients who report sustained complete pain resolution after the first application of ELS-M11. [ Time Frame: 24 hours ]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 to Initial Use of Rescue Medication following the first application of ELS-M11 [ Time Frame: 24 hours ]Time to Initial Use of Rescue Medication following ELS-M11 application in subjects experiencing moderate to severe headaches within a 24 hour period
- Use of Rescue Medication following the first application of ELS-M11 by 24 hours [ Time Frame: 24 hours ]Use of Rescue Medication within 24 hours following ELS-M11 application in patients experiencing moderate to severe migraine headaches.
- Resolution of migraine-associated symptoms, following the first application of ELS-M11 [ Time Frame: 24 hours ]Free of migraine-associated symptoms within 24 hours after ELS-M11 application in patients experiencing moderate to severe migraine headaches.
- Percentage of patients who can resume or maintain their normal routine, following the first application of ELS-M11. [ Time Frame: 24 hours ]Resuming or maintaining normal routine within 24 hours after first study medication application in moderate and severe headaches.
Original Secondary Outcome: Same as current
Information By: Achelios Therapeutics
Dates:
Date Received: February 5, 2014
Date Started: March 2014
Date Completion:
Last Updated: January 23, 2015
Last Verified: November 2014