Safety of Nerivio in Pregnant Women With Migraine
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ClinicalTrials.gov Identifier: NCT05464069 |
Recruitment Status :
Completed
First Posted : July 19, 2022
Last Update Posted : December 13, 2022
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Tracking Information | |||||||
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First Submitted Date | July 12, 2022 | ||||||
First Posted Date | July 19, 2022 | ||||||
Last Update Posted Date | December 13, 2022 | ||||||
Actual Study Start Date | August 1, 2022 | ||||||
Actual Primary Completion Date | November 28, 2022 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures |
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).
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Original Primary Outcome Measures | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | ||||||
Current Other Pre-specified Outcome Measures |
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
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Original Other Pre-specified Outcome Measures | Same as current | ||||||
Descriptive Information | |||||||
Brief Title | 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 | ||||||
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:
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Study Type | Observational | ||||||
Study Design | Observational Model: Cohort Time Perspective: Retrospective |
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Target Follow-Up Duration | Not Provided | ||||||
Biospecimen | Not Provided | ||||||
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." | ||||||
Condition |
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Intervention | 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
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Study Groups/Cohorts |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status | Completed | ||||||
Actual Enrollment |
115 | ||||||
Original Estimated Enrollment |
400 | ||||||
Actual Study Completion Date | December 7, 2022 | ||||||
Actual Primary Completion Date | November 28, 2022 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 42 Years (Adult) | ||||||
Accepts Healthy Volunteers | Yes | ||||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number | NCT05464069 | ||||||
Other Study ID Numbers | TCH011 | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Current Responsible Party | Theranica | ||||||
Original Responsible Party | Same as current | ||||||
Current Study Sponsor | Theranica | ||||||
Original Study Sponsor | Same as current | ||||||
Collaborators | Not Provided | ||||||
Investigators |
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PRS Account | Theranica | ||||||
Verification Date | June 2022 |