A Multicenter, Prospective, Single Arm, Open Label, Post-Market, Observational Study to evaluate the use of sTMS in reduction of Migraine Headache (ESPOUSE Study) (S52.004)

Objective: To evaluate the efficacy and tolerability of single pulse transcranial magnetic stimulation (sTMS) for the treatment of migraine.

Background: sTMS is an FDA-approved acute treatment for migraine with aura. Open label patient experience in the United Kingdom has suggested a possible preventive benefit in migraine.

Design/Methods: The ESPOUSE Study was a multicenter, prospective, single-arm, open label, observational study to evaluate sTMS for the treatment of migraine. From December 2014 to March 2016, 263 patients with migraine were consented to complete a 1-month baseline headache diary followed by 3 months of treatment. The full analysis set (FAS) included patients who completed the baseline headache diary, met the inclusion criteria including 5–25 headache days/month, and used the device at least once. The treatment protocol consisted of both preventive treatment (4 pulses twice daily) and acute treatment (3 pulses at 15 minute intervals repeated up to 3-times for each attack). The primary effectiveness endpoint (PEE), mean reduction of headache days compared to baseline, was measured over the 28-day period ending at 12 weeks. The PEE was compared to the performance goal which is a statistically-derived, estimated placebo effect size of −0.6 day reduction of headache days from baseline. There was no simultaneous placebo control.

Results: The PEE analysis was assessed in 132 subjects in the FAS population. The mean reduction of headache days from baseline compared to the performance goal was statistically significant. There was −2.8 ± 0.4 mean reduction of headache days from baseline (9.1 days) in the FAS (p<0.0001). There were no serious adverse events reported. The top three adverse events were lightheadedness (4.5%), tingling (3.9%), and tinnitus (3.9%). 9 patients withdrew from the study because of adverse events.

Conclusions: This open label study suggests that sTMS may be an effective, well-tolerated treatment option for migraine prevention.

Study Supported by:

The ESPOUSE Study was supported by eNeura Inc.

Disclosure: Dr. Starling has received personal compensation for activities with Amgen and eNeura as a consultant. Dr. Tepper has received personal compensation for activities with Acorda, Alder, Allergan, Amgen, ATI, Avanir, Dr. Reddy's, eNeura, Pfizer, Scion Neurostim, Teva, Zosana, Depomed, Impax, Pernix, Teva, Amgen, and Merck. Dr. Tepper has received personal compensation in an editorial capacity for Headache Currents. Dr. Tepper holds stock and/or stock options in ATI. Dr. Tepper has received research support from Alder, Allergan, Amgen, ATI, Scion Neurostim, Teva, Zosano. Dr. Marmura has received personsal compensation for activities with Teva and Supernus as a consultant. Dr. Marmura has received research support for Teva and eNeura. Dr. Shamim has nothing to disclose. Dr. Robbins has received personal compensation in an editorial capacity for Current Pain and Headache Reports. Dr. Robbins has received research support from eNeura. Dr. Hindiyeh has nothing to disclose. Dr. Charles has received personal compensation for activities with Amgen as a consultant and with eNeura and Eli Lilly for serving on the Scientific Advisory Board. Dr. Charles has received research support from Takeda. Dr. Goadsby has received personal compensation for activities with Allergan, eNeura, Autonomic Technologies Inc, Amgen, AlderBio, Pfizer, DrReddy, Zosano, Colucid, Eli Lilly, Avanir, Gore,Heptares, Nupathe, Teva, Cipla, Ajinomoto, Akita,Wells Fargo, Ethicon,Promius. Dr. Goadsby has received personal compensation in an editorial capacity for JournalWatch Neurology and UptoDate. Dr. Goadsby has received research supporting from Amgen, eNeura, Allergan. Dr. Lipton has received personal compensation from Allergan, American Headache Society, Autonomic Technologies, Boston Scientific, Bristol Myers Squibb, Cognimed, Colucid, Eli Lilly, eNeura Therapeutics, Merck, Novartis, Pfizer, TEVA, Vedanta. Dr. Silberstein has received research support from Allergan, Inc., Amgen, Cumberland Pharmaceuticals, Inc., ElectroCore Medical, LLC., Labrys Biologics, Eli Lilly and Company, and Merz. Dr. Dodick has received personal compensation for activities with Allergan, Amgen, Alder, Dr Reddy’s, Merck, eNeura, Eli Lilly & Company, INSYS therapeutics, Autonomic Technologies, Teva, Xenon, Tonix, Trigemina, Boston Scientific, GBS, Merck, Colucid, and Zosano. Dr. Dodick has received personal compensation in an editorial capacity for Oxford University Press, Cambridge University Press, Healthlogix, UptoDate. Dr. Dodick has received royalty payments from Oxford University Press, Cambridge University Press, Web MD and UptoDate. Dr. Dodick holds stock and/or stock options in Epien Medical, Second Opinion, GBS, and Neuroassessment systems.