Treatment with Nerivio did not differ from controls in outcomes of newborn weight, miscarriage rate, preterm birth rate, birth defect rate, stillbirths, and rate of newborns meeting developmental milestones 3 months postnatal.
Findings from a recently published retrospective controlled survey-study (NCT05464069) assessing the Nerivio (Theranica) remote electrical neuromodulation (REN) device indicated that the treatment was safe to use among pregnant women with migraine, with no increased risk for adverse pregnancy outcomes.
An online survey was sent to all females in the specified age range and within the REN device users’ database and to patients in participating headache clinics. At the conclusion of the analysis, findings showed no between-group statistical difference in the primary end point of gestational age between the REN (mean, 38 weeks and 5 days [±1 week and 6 days]) and control groups (mean, 39 weeks and 0 days [±1 week and 2 days; mean difference, 3 days; CI, –7 days to 1 day; P = .160).
Led by senior investigator Nina Riggins, MD, PhD, director of the Headache and Traumatic Brain Injury Center at UC San Diego Health, the trial compared women with migraine who treated their migraine with at least 3 REN treatments during pregnancy to women with migraine who did not use REN during pregnancy. Eligibility included a migraine diagnosis with at least 4 migraine days per month for at least 6 months prior to their last pregnancy, last menstrual period between November 2019 and August 2021, aged between 18 and 45 years, and at least 4 migraine attacks during the study pregnancy.
In total, 171 women completed the study, of which 140 (REN, n = 59; control, n = 81) met inclusion criteria for analysis. Similar to the primary end point, no statistically significant difference was observed between REN and controls on secondary end points of newborn weight (mean, 7.2 [±1.2] vs 7.2 [±1.0] pound; mean difference, 0 pound; CI, –0.4 to 0.4; P >.999), miscarriage rate (3.4% vs 3.7%; P =.918), preterm birth rate (14.0% vs 6.4%; P = .138), birth defect rate (14.0% vs 14.1%; P = .991), stillbirths rate (0% vs 0%; P >.999), rate of newborns meeting developmental milestones at 3 months postnatal (96.5% vs 94.9%; P = .652), and the rate of participants who visited emergency room during their pregnancy (15.3% vs 17.3%; P = .749).
Earlier this year, the FDA approved Nerivio as a dual-use acute and preventive treatment for migraine with or without aura in patients 12 years of age or older. The indication was supported by results from a randomized, placebo-controlled study in which Nerivio-treated patinets demonstrated a mean reduction of 4 migraine days per month compared with 1.3 days in the placebo group. In addition to showing net gains in the reduction of these migraine days, treated patients also showed statistically significant reductions in mean number of headache days of all severities and in number of days on which they required acute migraine medication.2
Nerivio is the first FDA-cleared smartphone-controlled prescription wearable device for acute migraine treatment of episodic or chronic migraine in people 12 years and older and received another prior approval in October 2020.3 At the time, it was only approved for patients aged 18 years and older.3 Its initial de novo clearance was granted in May 2019, for the acute treatment of migraine with or without aura in adults.3