MigraineNCT05464069

Safety of Nerivio in Pregnant Women With Migraine

An observational study of Migraine and Pregnancy Related, run by Theranica at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 42 years, women onlyHealthy volunteers can take part
Conditions the study is for: Migraine, Pregnancy Related
What is being tested?: Nerivio and Migraine Relief
Type of treatment: Medical device
How many people: 145 participants
Where: 2 sitesUnited States
Study dates: 1 Aug 2022to 7 Dec 2022
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 42 years
Women only
Healthy volunteers accepted
Adult

Study population: Post pregnant women between 18 and 42 years of age at first day of the last menstrual period (LMP) of "study pregnancy."

Who may be able to join

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

Who cannot join

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"

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Theranica USA
Montclair, New Jersey, 07042
University of California San Diego (UCSD)
San Diego, California, 92037

Other trials in United States

About this study

Official title: A Retrospective Controlled Survey Study to Assess the Safety of Treating Migraine With Nerivio During Pregnancy and 3 Months Postpartum

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.

Read the detailed description

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:

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

Conditions: Migraine, Pregnancy Related
Being tested: Nerivio, Migraine Relief
Medical subject headings: Migraine Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NerivioDevice
Also called Neriivo
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
Migraine ReliefDrug
Also called migraine treatment
Any drug for treatment of migraine relief

Study groups in NCT05464069
Study group	Role	What they receive
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 Receives: Device: Nerivio
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 Receives: Drug: Migraine Relief

What is being measured

The primary outcome is the main question the study is designed to answer.

Gestational Age at Delivery
The mean number of gestational age at delivery in both study groups (measured in pregnancy days).
Measured: Retrospective Data for up to 42 weeks, collected over 2 months

Secondary outcomes (7)

Birth Weight
The mean weight of the newborn children at the time of delivery in both study groups (measured in Pounds).
Measured: Retrospective Data for up to 42 weeks, collected over 2 months
Miscarriage Rate
The percent of miscarriage in both study groups
Measured: Retrospective Data for up to 42 weeks, collected over 2 months
Preterm Birth Rate
The percent of preterm birth (measured in % of pregnancy weeks less than 37) in both study groups
Measured: Retrospective Data for up to 42 weeks, collected over 2 months
Birth Deficits Rate
The percent of birth deficits in both study groups
Measured: Retrospective Data for up to 42 weeks, collected over 2 months
Still Births Rate
The percent of Still birth in both study groups
Measured: Retrospective Data for up to 42 weeks, collected over 2 months
Developmental Milestones Rate Following 3 Months Postnatal
The 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)
Measured: Retrospective Data for up to 55 weeks, collected over 2 months
Migraine Patterns
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
Measured: Retrospective Data for up to 55 weeks, collected over 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 20227 Dec 2022

First posted19 Jul 2022
Study start1 Aug 2022
Primary completion28 Nov 2022
Study completion7 Dec 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for MigraineStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 145 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05464069
Sponsor's protocol ID: TCH011
Status last verified: Jun 2022
First submitted: 12 Jul 2022
Last updated: 6 Oct 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Peretz A, Stark-Inbar A, Harris D, Tamir S, Shmuely S, Ironi A, Halpern A, Chuang L, Riggins N. Safety of remote electrical neuromodulation for acute migraine treatment in pregnant women: A retrospective controlled survey-study. Headache. 2023 Jul-Aug;63(7):968-970. doi: 10.1111/head.14586. Epub 2023 Jun 19. No abstract available.
PubMed 37335242

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Migraine trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Retrospective Controlled Survey Study to Assess the Safety of Treating Migraine With Nerivio During Pregnancy and 3 Months Postpartum
ClinicalTrials.gov ID: NCT05464069
Acronym / sponsor ID: TCH011
Conditions: Migraine, Pregnancy Related
Study type: Observational
Recruitment status: Completed
Enrolment: 145 participants (actual)
Lead sponsor: TheranicaIndustry (pharma, biotech, devices)
Study start: 1 Aug 2022 (actual)
Primary completion: 28 Nov 2022 (actual)
Study completion: 7 Dec 2022 (actual)
First posted: 19 Jul 2022 (actual)
Results: Posted 6 Oct 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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:

Baby's birth weight (average birth weight)
Miscarriage rate (% of miscarriage cases)
Preterm birth rate (% cases of preterm pregnancies, as measured in % of pregnancy weeks less than 37)
Birth deficits rate (% of birth deficits)
Still births rate (% of still births)
Meeting developmental milestones following 3 months postnatal (% of babies)
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

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
Postpartum females with migraine who used Nerivio during their pregnancy	–	Device: NerivioPostpartum patients with migraine who used Nerivio at least 3 times during their pregnancy. Participants will be recruited from Nerivio's user database
Postpartum females with migraine who used other migraine therapy during their pregnancy	–	Drug: Migraine ReliefPostpartum 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

Who may qualify

Ages: 18 to 42 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult
Study population: Post pregnant women between 18 and 42 years of age at first day of the last menstrual period (LMP) of "study pregnancy."

Key inclusion criteria (7 listed)

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"

Key exclusion criteria (4 listed)

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"

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
NerivioAlso: NeriivoNerivio 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	Device	Postpartum females with migraine who used Nerivio during their pregnancy
Migraine ReliefAlso: migraine treatmentAny drug for treatment of migraine relief	Drug	Postpartum females with migraine who used other migraine therapy during their pregnancy

Primary outcome

Gestational Age at Delivery
Time frame: Retrospective Data for up to 42 weeks, collected over 2 months
The mean number of gestational age at delivery in both study groups (measured in pregnancy days).

7 secondary outcomes

Birth Weight
Time frame: Retrospective Data for up to 42 weeks, collected over 2 months
Miscarriage Rate
Time frame: Retrospective Data for up to 42 weeks, collected over 2 months
Preterm Birth Rate
Time frame: Retrospective Data for up to 42 weeks, collected over 2 months
Birth Deficits Rate
Time frame: Retrospective Data for up to 42 weeks, collected over 2 months
Still Births Rate
Time frame: Retrospective Data for up to 42 weeks, collected over 2 months
Developmental Milestones Rate Following 3 Months Postnatal
Time frame: Retrospective Data for up to 55 weeks, collected over 2 months
Migraine Patterns
Time frame: Retrospective Data for up to 55 weeks, collected over 2 months

Results and safety

Results posted to the registry on 6 Oct 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Postpartum Females With Migraine Who Used Nerivio During Their Pregnancy	62	59
Postpartum Females With Migraine Who Used Other Migraine Therapy During Their Pregnancy	83	81

Primary outcome: Gestational Age at Delivery

Time frame: Retrospective Data for up to 42 weeks, collected over 2 months. Mean (Standard Deviation). Unit: Gestational days

Measure	Postpartum Females With Migraine Who Used Nerivio During Their Pregnancy n = 59	Postpartum Females With Migraine Who Used Other Migraine Therapy During Their Pregnancy n = 81
Value	271 (13)	273 (9)

Postpartum Females With Migraine Who Used Nerivio During Their Pregnancy vs Postpartum Females With Migraine Who Used Other Migraine Therapy During Their Pregnancy: p = 0.160, t-test, 2 sided

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Retrospective Data for up to 42 weeks, collected over 2 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Postpartum Females With Migraine Who Used Nerivio During Their Pregnancy	0 of 59 (0%)	0 of 59 (0%)	0 of 59
Postpartum Females With Migraine Who Used Other Migraine Therapy During Their Pregnancy	0 of 81 (0%)	0 of 81 (0%)	0 of 81

Limitations and caveats (from the sponsor): 1. \- The retrospective nature of the study may limit the conclusions of this survey by recall bias 2. \- The REN group included 59 patients, making it smaller than groups included in other studies assessing the efficacy and safety of migraine treatments in the general population

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 37335242Peretz A, Stark-Inbar A, Harris D, Tamir S, Shmuely S, Ironi A, Halpern A, Chuang L, Riggins N. Safety of remote electrical neuromodulation for acute migraine treatment in pregnant women: A retrospective controlled survey-study. Headache. 2023 Jul-Aug;63(7):968-970. doi: 10.1111/head.14586. Epub 2023 Jun 19. No abstract available.
Pubmed referenceLink provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Alit Stark Inbar, PhD principal investigator

Theranica USA

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Migraine and Pregnancy Related, run by Theranica at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Gestational Age at Delivery (time frame: Retrospective Data for up to 42 weeks, collected over 2 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05464069, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2025.