Safety of Nerivio in Pregnant Women With Migraine

• ClinicalTrials.gov Identifier: NCT05464069
• Recruitment Status: Completed
• First Posted: July 19, 2022
• Last Update Posted: December 13, 2022
• Sponsor: Theranica
• Information provided by (Responsible Party): Theranica

Study Description

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.

Condition or disease	Intervention/treatment
Migraine; Pregnancy Related	Device: Nerivio

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)

Study Design

• Study Type: Observational
• Actual Enrollment: 115 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: A Retrospective Controlled Survey Study to Assess the Safety of Treating Migraine With Nerivio During Pregnancy and 3 Months Postpartum
• Actual Study Start Date: August 1, 2022
• Actual Primary Completion Date: November 28, 2022
• Actual Study Completion Date: December 7, 2022

Groups and Cohorts

Group/Cohort	Intervention/treatment
Postpartum with migraine who used Nerivio during their pregnancy; Postpartum patients with migraine who used Nerivio at least 3 times during their pregnancy. Participants will be recruited from Nerivio's user database	Device: Nerivio; Nerivio is a Remote Electrical Neuromodulation (REN) device for the acute treatment of migraines. The device delivers transcutaneous electrical stimulation to the upper arm to induce conditioned pain modulation (CPM) that activates a descending endogenous analgesic mechanism. The treatment is self-administered and controlled by a smartphone application
Postpartum with migraine who used other migraine therapy during their pregnancy; Postpartum patients with migraine who used did not used Nerivio prior to their pregnancy, during their pregnancy and at least 3 months postpartum. 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

Outcome Measures

Primary Outcome Measures :

1. Non-inferiority of the study group in terms of gestational age at delivery [ Time Frame: 42 weeks ]
   The mean number of gestational age at delivery in both study groups (measured in pregnancy weeks).

Secondary Outcome Measures :

1. Similarity between groups in terms of birth weight [ Time Frame: 1 day ]
   The mean weight of the newborn children at the time of delivery in both study groups (measured in Kg).
2. Non-inferiority of the study group in term of miscarriage rate [ Time Frame: 40 weeks ]
   The percent of miscarriage in both study groups
3. Non-inferiority of the study group in terms of preterm birth rate [ Time Frame: 40 weeks ]
   The percent of preterm birth (measured in % of pregnancy weeks less than 37) in both study groups
4. Non-inferiority of the study group in terms of birth deficits rate [ Time Frame: 42 weeks ]
   The percent of birth deficits in both study groups
5. Non-inferiority of the study group in terms of Still births rate [ Time Frame: 42 weeks ]
   The percent of Still birth in both study groups
6. Non-inferiority of the study group in terms of developmental milestones following 3 months postnatal [ Time Frame: 3 months ]
   The mean score of developmental milestones in both study groups
7. Similarity between groups in terms of migraine patterns [ Time Frame: 12 months ]
   The proportion of patients that visits the emergency room or urgent care due to pregnancy and/or migraine symptoms during pregnancy and 3 months postpartum period in both study groups

Other Outcome Measures:

1. Non-inferiority of the study group in terms of subjective assessment of safety and confidence of using migraine therapy during pregnancy [ Time Frame: 42 weeks ]
   The mean score of the assessment questionnaire in both study groups

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 42 Years (Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: Postpartum women
• Accepts Healthy Volunteers: Yes
• 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."

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"

Contacts and Locations

Locations

United States, California

University of California San Diego (UCSD)

San Diego, California, United States, 92037

United States, New Jersey

Theranica USA

Montclair, New Jersey, United States, 07042

Sponsors and Collaborators

Theranica

Investigators

• Principal Investigator: Alit Stark Inbar, PhD; Theranica USA

More Information

• Responsible Party: Theranica
• ClinicalTrials.gov Identifier: NCT05464069
• Other Study ID Numbers: TCH011
• First Posted: July 19, 2022
• Last Update Posted: December 13, 2022
• Last Verified: June 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:

Migraine Disorders; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases