Significant reduction in migraine days with Remote Electrical Neuromodulation (REN) for migraine prevention: A double-blind randomized sham-controlled clinical trial
Stewart Tepper1, Liron Rabany2, Robert Cowan3, Timothy Smith4, Brian Grosberg5, Brad Torphy6, Dagan Harris7, Maya Vizel8, Alon Ironi9, Alit Stark-Inbar8, Sandy Garas10, Andrew Blumenfeld11
1Geisel School of Medicine At Dartmouth, 2Theranica Bio-Electronics Ltd., 3Stanford Neurosciences Health Center, 4StudyMetrix Research, 5Hartford HealthCare Headache Center, 6Chicago Headache Center and Research Institute, 7Theranica BioElectronics Ltd, 8Theranica Bio-Electronics, 9Theranica, 10Theranica USA, 11The Los Angeles and San Diego Headache Centers
Objective:
The aim of the present clinical trial was to evaluate the efficacy and safety of Remote Electrical Neuromodulation (REN), used every other day, for the prevention of migraine in a multi-center, randomized, double blind, placebo-controlled study.
Background:
Migraine affects over 1 billion people worldwide causing significant disability and a socioeconomic burden. Preventive treatment is key to managing migraine, but it is often underutilized. There is an unmet need for non-pharmacological migraine prevention that is both effective and well tolerated. REN, a non-pharmacological acute migraine treatment, was evaluated as a method of migraine prevention in patients with episodic and chronic migraine.
Design/Methods:
We conducted a prospective, randomized, double-blind, sham-controlled, multi-center trial, with 1:1 ratio. The study consisted of a four-week baseline observation phase, and an eight-week double-blind intervention phase in which subjects used either REN or a sham stimulation every other day. Throughout the study, subjects reported their symptoms daily, via an electronic diary.
Results:
Two hundred and forty-eight subjects were randomized (128 active, 120 placebo), of which 179 qualified for the mITT analysis (95 active; 84 placebo). REN was superior to placebo in the primary endpoint-change in mean number of migraine days per month from baseline, with a mean change of -4.0±0.4 days (-1.3±0.4 in placebo, gain =-2.7, p=0.00002). The significance was maintained when analyzing the episodic (-3.2 vs -1.0; p=0.003) and chronic (-4.7 vs -1.6; p=0.001) migraine subgroups separately. A significant reduction in migraine days was also maintained in subjects using a preventative in addition to REN (-3.5 vs -1.5; p=0.03) and in those with no additional prophylaxis (-4.5 vs -1.5; p=0.00016). No serious device-related adverse events were reported in any group.
Conclusions:
Applied every other day, REN is effective and safe for the prevention of migraine.