Abstract Details

Title TOPICALLY APPLIED KETOPROFEN GEL (ELS-M11) IN THE TREATMENT OF SEVERE MIGRAINE PAIN

Topic Headache

Presentation(s) (-)

Poster/Presentation
Number 013

Objective

Background Pathogenesis of migraine involves neurogenic inflammation, with release of CGRP and other neuropeptides from perivascular trigeminal afferents, resulting in vasodilation and plasma-protein extravasation within the dura mater. By inhibiting cyclooxygenase, NSAIDs prevent production of prostanoids that can sustain neurogenic inflammation. Oral NSAIDs can be anti-inflammatory and analgesic, but cause undesirable side effects. Topical NSAIDs represent an alternative to oral NSAIDs, with similar mechanism, but targeting trigeminal nerve peripherals directly by gel application to skin, with minimal systemic exposure.

Design/Methods This was a randomized, crossover, double-blind, placebo-controlled study of 48 screened subjects, ages 18-65, with a history of episodic migraine for ?1 year, meeting ICHD-II w/o aura. Patients treated five moderate or severe migraines and recorded symptoms at scheduled times using a tablet-computer. ELS-M11, a gel with potent skin permeation of ketoprofen, was applied facially-bilaterally over all three trigeminal divisions.

Results 42 randomized patients (mean age 44; 83% female) had a total of 130 headache events. 22 patients experienced 49 severe headaches, with 22 treated with ELS-M11 and 27 with placebo. 45% of headaches treated with ELS-M11 had sustained pain relief from 2 to 24 hours as compared to 15% of placebo headaches. By four hours, 23% of headaches treated with ELS-M11 were pain free, as compared to 15% with placebo. At 24 hours, 50% of headaches treated with ELS-M11 had pain relief and were pain free versus 25% of placebo. Patients whose headaches were treated with ELS-M11, were at least 3x as likely to experience relief of associated symptom (nausea, photophobia) vs. placebo. Unwanted effects were application site irritation, predominantly mild or moderate and resolving quickly.

Conclusions This study provides evidence supporting that topical non-steroidal anti-inflammatory therapy can be an effective treatment for acute migraine.

Authors/Disclosures
Wolfgang Liedtke, MD, PhD (Duke University, Dept. of Neurology)	No disclosure on file
William R. Bauer, MD, PhD, FAAN (Northern Ohio Neuroscience)	No disclosure on file
Susan Walker (Apex Biostatistics)	No disclosure on file
Crist J. Frangakis, PhD (Achelios Therapeutics)	No disclosure on file
Joel R. Saper, MD, FAAN (MHNI)	No disclosure on file

��ɫ��

��ɫ��