Retrospective Controlled Survey Study to Assess the Safety of Treating Migraine With Nerivio During Pregnancy and 3 Months Postpartum (NCT05464069)

The prevalence of migraine among women is highest during reproductive years. Women with migraine and their offspring face an increased risk for adverse pregnancy outcomes. Adverse pregnancy outcomes (APOs), including gestational diabetes, preterm birth, fetal growth restriction, and hypertensive disorders of pregnancy (gestational hypertension, preeclampsia, and related disorders) are major health risks for pregnant individuals during pregnancy and throughout their lifespan. There are evidence that demonstrate the association between migraine history and adverse pregnancy and APOs.

This retrospective controlled survey-study (ClinicalTrial.Gov NCT05464069) evaluated the safety of Nerivio for migraine treatment during pregnancy through 3 months postpartum, relative to other options (medications or no treatment). It compared women with migraine who treated their migraine with at least three Nerivio treatments during pregnancy (Nerivio group) to women with migraine who did not use Nerivio during pregnancy (control group) on critical pregnancy outcomes.

Safety outcome

The primary endpoint was defined as Non-Inferiority of Nerivio group to control group with regard to gestational age at delivery. Additional 7 secondary endpoints related to APOs were defined as well. These outcomes included newborn weight, miscarriage

rate, preterm birth rate, birth defect rate, stillbirths rate, rate of newborns meeting developmental milestones at 3 months postnatal, and rate of participants who visited emergency room during their pregnancy.

Participants disposition

Invitation to participate in the study was sent by the sites to potential candidates. 418 candidates responded to the invitation. 206 were found to be eligible through eligibility questionnaire. 188 of them signed the electronic Informed Concent Form (eICF). 171 completed the study survey. 31 were excluded from the analysis due to various reasons. A totral of 140 participants were included in the analysis (Nerivio group n=59, Control group n=81).

Results

There was no statistical difference in the primary endpoint of gestational age between the Nerivio group and the control group, as can be seen in Table 1.

Primary endpointNerivioControlp-ValueGestational Age (mean ± SD)38 weeks & 5 days ±1 week & 6 days39 weeks & 0 days ±1 week & 2 days0.160Mean Difference [95% CI]-3 days; [95%CI ( −7 days to 1 day)]

Table 1 – Results of primary endpoint

There were no statistical differences between the Nerivio group and the control group in all measured adverse pregnancy outcomes. All seven secondary endpoints did not differ between REN and control groups:

1. Newborn weight (mean ± SD: 2 ± 1.2 vs. 7.2 ± 1.0 pound; mean difference of 0 pounds; 95% confidence interval: −0.4 to 0.4; p > 0.999)
2. Miscarriage rate (3.4% 3.7%, p = 0.918)
3. Preterm birth rate (14.0% 6.4%; p = 0.138)
4. Birth defect rate (14.0% 14.1%, p = 0.991)
5. Stillbirths rate (0% 0%; p > 0.999)
6. Rate of newborns meeting developmental milestones at 3 months postnatal (96.5% vs. 94.9%; p = 0.652)
7. Rate of participants who visited emergency room during their pregnancy (15.3% 17.3%; p = 0.749).

Results indicated that the Nerivio device is a safe treatment of migraine during pregnancy, not increasing the risk for adverse pregnancy outcomes, and therefore offering a much-needed non-pharmacological alternative for women with migraine during pregnancy.

‍