The RIME study evaluated the acute treatment of migraine with the Relivion®MG device on a total of 109 subjects meeting the diagnostic criteria for migraine with and without aura. Subjects self-administered a one-hour treatment with the device during a migraine headache. Migraine symptoms were reported prior to treatment and 1, 2 and 24 hours post treatment. The preventive study included 17 subjects with high-frequency episodic migraine or chronic migraine, that self-administered daily 20-minute treatments with the Relivion MG and reported migraine symptoms for a duration of 3-6 months. Efficacy measures included pain and MBS freedom for acute treatment in the RIME study and change (%) in monthly migraine days in the preventive study.

For RIME efficacy results, pain and MBS freedom 2 hours post treatment, Relivion MG was superior to sham, 46% pain freedom vs 11.8% (p<0.0001) and 75% MBS freedom vs 46.7% (p=0.009), respectively. Complete freedom of migraine symptoms (pain as well as MBS) at 2-hours was also significantly higher (47.2% vs. 11.1%, p=0.0003). For the preventive treatment, average migraine days frequency decreased by 63%, from 14.6 days per month at baseline to 5.4 days at the final treatment month (p<0.0001). Patient responder rate (≥50% reduction in monthly migraine days) was 76%. No serious adverse events were reported in both studies.

These results demonstrate that Relivion MG provides a highly effective and safe option in the acute treatment of migraine and extremely promising results in the prevention of migraine.