Safety of Nerivio in Pregnant Women With Migraine

Completed

Conditions studied: Migraine, Pregnancy Related

In brief

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.

Key facts

Study ID

NCT05464069

Run by

Theranica

People needed

145

Starts

2022-08-01

Expected to finish

2022-12-07

Last updated by the study team

2025-10-06

Who can join

Age: 18 and older, up to 42. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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"

Where it is running

• University of California San Diego (UCSD) — San Diego, California, United States
• Theranica USA — Montclair, New Jersey, United States

Full record on ClinicalTrials.gov

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