N/A
N=145
Safety of Nerivio in Pregnant Women With Migraine
Migraine · Pregnancy Related
Bottom Line
View on ClinicalTrials.gov: NCT05464069 ↗Enrolled (actual)
145
Serious AEs
0.0%
Results posted
Oct 2025
Primary outcome: Primary: Gestational Age at Delivery — 271; 273 Gestational days — p=0.160
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Nerivio (Device); Migraine Relief (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Theranica
- Primary completion
- Nov 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Gestational Age at Delivery |
271; 273 | 0.160 |
| SECONDARY Birth Weight |
7.2; 7.2 | — |
| SECONDARY Miscarriage Rate |
2; 3 | — |
| SECONDARY Preterm Birth Rate |
8; 5 | — |
| SECONDARY Birth Deficits Rate |
8; 11 | — |
| SECONDARY Still Births Rate |
0; 0 | — |
| SECONDARY Developmental Milestones Rate Following 3 Months Postnatal |
57; 77 | — |
| SECONDARY Migraine Patterns |
9; 14 | — |
Summary
This is a retrospective controlled survey study to assess the safety of treating migraine with Nerivio during pregnancy and 3 months postpartum. The study will compare migraine and pregnancy-related health and baby health between women with migraine who treated migraine attacks during pregnancy with Nerivio (Nerivio group), to women with migraine who did not treat migraine attacks during pregnancy with Nerivio (control group). Nerivio group participants will be recruited from Theranica's user base. Control group participants will be recruited by health care providers, including headache specialists and OBGYNs (study co-investigators). The study is based on an e-Survey including an e-eligibility questionnaire, an e-ICF ande-Questionnaire. Participants will be compensated for their time.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with migraine
- History of migraine pre-pregnancy with an average of at least 4 migraine days per month, in the six months prior to the last pregnancy
- History of pregnancy with last menstrual period (LMP) between November 1st, 2019 - March 31st, 2021. Pregnancy within this time window is the pregnancy of study, termed "study pregnancy"
- Between 18 and 42 years of age at first day of the last menstrual period (LMP) of "study pregnancy"
- History of at least 4 migraine attacks during "study pregnancy"
- In the study group: usage of Nerivio for at least 3 treatments (≥30 minutes/treatment) during "study pregnancy"
- In the control group: No history of using Nerivio, ever
Exclusion Criteria
- History of preterm birth (gestational age at deliver<37 weeks) in previous pregnancies prior to the "study pregnancy"
- History of congenital malformations or birth defects in previous pregnancies prior to the "study pregnancy"
- Severe other diseases which started before the "study pregnancy" and lasted into the "study pregnancy" period, including congenital heart disease, arrhythmia, history of myocardial infarction (MI), history of stroke, or active cancer
- Serious physical injury that occurred during the "study pregnancy": severe car collision injury, serious injury at home/work, etc. Multiple gestation (i.e., pregnancy with more than one baby at a time, such as pregnancy with twins, triplets, and quadruplets) in the "study pregnancy"
Data sourced from ClinicalTrials.gov (NCT05464069). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.