Trial Outcomes & Findings for Safety of Nerivio in Pregnant Women With Migraine (NCT NCT05464069)
NCT ID: NCT05464069
Last Updated: 2025-10-06
Results Overview
The mean number of gestational age at delivery in both study groups (measured in pregnancy days).
Recruitment status
COMPLETED
Target enrollment
145 participants
Primary outcome timeframe
Retrospective Data for up to 42 weeks, collected over 2 months
Results posted on
2025-10-06
Participant Flow
Participant milestones
| Measure |
Postpartum Females 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
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 Females With Migraine Who Used Other Migraine Therapy During Their Pregnancy
Postpartum patients with migraine who did not used Nerivio prior and 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
Migraine Relief: Any drug for treatment of migraine relief
|
|---|---|---|
|
Overall Study
STARTED
|
62
|
83
|
|
Overall Study
COMPLETED
|
59
|
81
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
Postpartum Females 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
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 Females With Migraine Who Used Other Migraine Therapy During Their Pregnancy
Postpartum patients with migraine who did not used Nerivio prior and 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
Migraine Relief: Any drug for treatment of migraine relief
|
|---|---|---|
|
Overall Study
Protocol Violation
|
3
|
2
|
Baseline Characteristics
Safety of Nerivio in Pregnant Women With Migraine
Baseline characteristics by cohort
| Measure |
Postpartum Females With Migraine Who Used Nerivio During Their Pregnancy
n=59 Participants
Postpartum patients with migraine who used Nerivio at least 3 times during their pregnancy. Participants will be recruited from Nerivio's user database
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 Females With Migraine Who Used Other Migraine Therapy During Their Pregnancy
n=81 Participants
Postpartum patients with migraine who did not used Nerivio prior and 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
Migraine Relief: Any drug for treatment of migraine relief
|
Total
n=140 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32.6 years
STANDARD_DEVIATION 6.1 • n=5 Participants
|
32.2 years
STANDARD_DEVIATION 6.0 • n=7 Participants
|
32.4 years
STANDARD_DEVIATION 6.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
59 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
140 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White or Caucasian
|
46 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
26.8 Kg/m^2
STANDARD_DEVIATION 7.4 • n=5 Participants
|
25.8 Kg/m^2
STANDARD_DEVIATION 6.1 • n=7 Participants
|
26.2 Kg/m^2
STANDARD_DEVIATION 6.7 • n=5 Participants
|
PRIMARY outcome
Timeframe: Retrospective Data for up to 42 weeks, collected over 2 monthsThe mean number of gestational age at delivery in both study groups (measured in pregnancy days).
Outcome measures
| Measure |
Postpartum Females With Migraine Who Used Nerivio During Their Pregnancy
n=59 Participants
Postpartum patients with migraine who used Nerivio at least 3 times during their pregnancy. Participants will be recruited from Nerivio's user database
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 Females With Migraine Who Used Other Migraine Therapy During Their Pregnancy
n=81 Participants
Postpartum patients with migraine who did not used Nerivio prior and 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
Migraine Relief: Any drug for treatment of migraine relief
|
|---|---|---|
|
Gestational Age at Delivery
|
271 Gestational days
Standard Deviation 13
|
273 Gestational days
Standard Deviation 9
|
SECONDARY outcome
Timeframe: Retrospective Data for up to 42 weeks, collected over 2 monthsThe mean weight of the newborn children at the time of delivery in both study groups (measured in Pounds).
Outcome measures
| Measure |
Postpartum Females With Migraine Who Used Nerivio During Their Pregnancy
n=59 Participants
Postpartum patients with migraine who used Nerivio at least 3 times during their pregnancy. Participants will be recruited from Nerivio's user database
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 Females With Migraine Who Used Other Migraine Therapy During Their Pregnancy
n=81 Participants
Postpartum patients with migraine who did not used Nerivio prior and 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
Migraine Relief: Any drug for treatment of migraine relief
|
|---|---|---|
|
Birth Weight
|
7.2 Weight (pounds)
Standard Deviation 1.2
|
7.2 Weight (pounds)
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: Retrospective Data for up to 42 weeks, collected over 2 monthsThe percent of miscarriage in both study groups
Outcome measures
| Measure |
Postpartum Females With Migraine Who Used Nerivio During Their Pregnancy
n=59 Participants
Postpartum patients with migraine who used Nerivio at least 3 times during their pregnancy. Participants will be recruited from Nerivio's user database
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 Females With Migraine Who Used Other Migraine Therapy During Their Pregnancy
n=81 Participants
Postpartum patients with migraine who did not used Nerivio prior and 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
Migraine Relief: Any drug for treatment of migraine relief
|
|---|---|---|
|
Miscarriage Rate
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Retrospective Data for up to 42 weeks, collected over 2 monthsThe percent of preterm birth (measured in % of pregnancy weeks less than 37) in both study groups
Outcome measures
| Measure |
Postpartum Females With Migraine Who Used Nerivio During Their Pregnancy
n=59 Participants
Postpartum patients with migraine who used Nerivio at least 3 times during their pregnancy. Participants will be recruited from Nerivio's user database
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 Females With Migraine Who Used Other Migraine Therapy During Their Pregnancy
n=81 Participants
Postpartum patients with migraine who did not used Nerivio prior and 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
Migraine Relief: Any drug for treatment of migraine relief
|
|---|---|---|
|
Preterm Birth Rate
|
8 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Retrospective Data for up to 42 weeks, collected over 2 monthsThe percent of birth deficits in both study groups
Outcome measures
| Measure |
Postpartum Females With Migraine Who Used Nerivio During Their Pregnancy
n=59 Participants
Postpartum patients with migraine who used Nerivio at least 3 times during their pregnancy. Participants will be recruited from Nerivio's user database
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 Females With Migraine Who Used Other Migraine Therapy During Their Pregnancy
n=81 Participants
Postpartum patients with migraine who did not used Nerivio prior and 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
Migraine Relief: Any drug for treatment of migraine relief
|
|---|---|---|
|
Birth Deficits Rate
|
8 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Retrospective Data for up to 42 weeks, collected over 2 monthsThe percent of Still birth in both study groups
Outcome measures
| Measure |
Postpartum Females With Migraine Who Used Nerivio During Their Pregnancy
n=59 Participants
Postpartum patients with migraine who used Nerivio at least 3 times during their pregnancy. Participants will be recruited from Nerivio's user database
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 Females With Migraine Who Used Other Migraine Therapy During Their Pregnancy
n=81 Participants
Postpartum patients with migraine who did not used Nerivio prior and 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
Migraine Relief: Any drug for treatment of migraine relief
|
|---|---|---|
|
Still Births Rate
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Retrospective Data for up to 55 weeks, collected over 2 monthsThe rate of developmental milestones between the study groups. Develpment milestones includes motor skills, hearing, vision and communication (e.g bringing hands to their mouth, and recognizing familiar voices and faces)
Outcome measures
| Measure |
Postpartum Females With Migraine Who Used Nerivio During Their Pregnancy
n=59 Participants
Postpartum patients with migraine who used Nerivio at least 3 times during their pregnancy. Participants will be recruited from Nerivio's user database
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 Females With Migraine Who Used Other Migraine Therapy During Their Pregnancy
n=81 Participants
Postpartum patients with migraine who did not used Nerivio prior and 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
Migraine Relief: Any drug for treatment of migraine relief
|
|---|---|---|
|
Developmental Milestones Rate Following 3 Months Postnatal
|
57 Participants
|
77 Participants
|
SECONDARY outcome
Timeframe: Retrospective Data for up to 55 weeks, collected over 2 monthsThe 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
Outcome measures
| Measure |
Postpartum Females With Migraine Who Used Nerivio During Their Pregnancy
n=59 Participants
Postpartum patients with migraine who used Nerivio at least 3 times during their pregnancy. Participants will be recruited from Nerivio's user database
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 Females With Migraine Who Used Other Migraine Therapy During Their Pregnancy
n=81 Participants
Postpartum patients with migraine who did not used Nerivio prior and 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
Migraine Relief: Any drug for treatment of migraine relief
|
|---|---|---|
|
Migraine Patterns
|
9 Participants
|
14 Participants
|
Adverse Events
Postpartum Females With Migraine Who Used Nerivio During Their Pregnancy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Postpartum Females With Migraine Who Used Other Migraine Therapy During Their Pregnancy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr Dagan Harris, VP Clinical and Regulatory Affairs
Theranica
Phone: +972542220121
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place