Clinical trial NCT05464069: Safety of Nerivio in Pregnant Women With Migraine
Official title: A Retrospective Controlled Survey Study to Assess the Safety of Treating Migraine With Nerivio During Pregnancy and 3 Months Postpartum
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Migraine
Pregnancy Related
Lead sponsor: Theranica
Sponsor class: INDUSTRY
First posted: 2022-07-19
Enrollment: 115
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Post pregnant women between 18 and 42 years of age at first day of the last menstrual period (LMP) of "study pregnancy."

Brief 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.

Detailed description: 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).

Study group: Study group participants will be recruited from Nerivio's user base. An invitation message will be sent via in-app notification and/or email to all Nerivio users who are (1) female, AND (2) between 18 and 42 years of age as of November 1st, 2019 - March 31st, 2021. Users who meet these criteria will be invited to fill in a screening and eligibility questionnaire. If they meet the eligibility criteria, they will be offered the opportunity to participate in the study. Participants will complete and sign an electronic informed consent form. Following consent, participants will be asked to complete the questionnaire. Once complete, participants will be compensated for their time.

Control group: Control group participants will be referred to the study by site co-investigators, who are US-licensed healthcare providers seeing women with headache disorders and/or women during their pre-pregnancy and/or pregnancy period. Patients interested in participating will be directed to the same screening and eligibility questionnaire and will follow the same study design.

Endpoints focus on the health of the mother and the baby, during pregnancy and three months postpartum.

Primary endpoint:

Demonstrate that the study group is not different than the control group in regard to gestational age at delivery (measured in pregnancy weeks).

Secondary endpoints:

Demonstrate that the study group is not different from the control group in:

1. Baby's birth weight (average birth weight)
2. Miscarriage rate (% of miscarriage cases)
3. Preterm birth rate (% cases of preterm pregnancies, as measured in % of pregnancy weeks less than 37)
4. Birth deficits rate (% of birth deficits)
5. Still births rate (% of still births)
6. Meeting developmental milestones following 3 months postnatal (% of babies)
7. Visits to the emergency room or urgent care due to pregnancy and/or migraine symptoms during pregnancy and 3 months postpartum period (# of events)

Eligibility criteria: Inclusion Criteria:

1. Diagnosed with migraine
2. 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
3. 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"
4. Between 18 and 42 years of age at first day of the last menstrual period (LMP) of "study pregnancy"
5. History of at least 4 migraine attacks during "study pregnancy"
6. In the study group: usage of Nerivio for at least 3 treatments (≥30 minutes/treatment) during "study pregnancy"
7. In the control group: No history of using Nerivio, ever

Exclusion Criteria:

1. History of preterm birth (gestational age at deliver\<37 weeks) in previous pregnancies prior to the "study pregnancy"
2. History of congenital malformations or birth defects in previous pregnancies prior to the "study pregnancy"
3. 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
4. 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"

Primary outcomes:
measure: Non-inferiority of the study group in terms of gestational age at delivery
timeFrame: 42 weeks
Secondary outcomes:
measure: Similarity between groups in terms of birth weight
timeFrame: 1 day
measure: Non-inferiority of the study group in term of miscarriage rate
timeFrame: 40 weeks
measure: Non-inferiority of the study group in terms of preterm birth rate
timeFrame: 40 weeks
measure: Non-inferiority of the study group in terms of birth deficits rate
timeFrame: 42 weeks
measure: Non-inferiority of the study group in terms of Still births rate
timeFrame: 42 weeks
measure: Non-inferiority of the study group in terms of developmental milestones following 3 months postnatal
timeFrame: 3 months
measure: Similarity between groups in terms of migraine patterns
timeFrame: 12 months
Other outcomes:
measure: Non-inferiority of the study group in terms of subjective assessment of safety and confidence of using migraine therapy during pregnancy
timeFrame: 42 weeks
Locations:
city: San Diego
country: United States
facility: University of California San Diego (UCSD)
state: California
city: Montclair
country: United States
facility: Theranica USA
state: New Jersey
Study officials:
affiliation: Theranica USA
name: Alit Stark Inbar, PhD
role: PRINCIPAL_INVESTIGATOR
References: