Adults 18 to 75, any sex, with Migraine Without Aura or Migraine With Aura. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants With Reduction of Migraine Headache at 2 Hours Post TreatmentPrimary· 2 hours post migraine onset
The percentage of patients reporting reduction in their pain level 2 hours post-treatment without rescue medications from severe or moderate to mild or no pain, or from mild to no pain, in their first treated migraine attack (excluding the "run-in test" treatment).
Group
Value
95% CI
Treatment of Migraine With Active Device
66
Treatment of Migraine With Sham Device
40
Percentage of Participants With Reduction of Most Bothersome Migraine-associated Symptom (MBS) Relief at 2 Hours Post TreatmentSecondary· 2 hours post migraine onset
The percentage of patients reporting, 2 hours post-treatment, freedom from their most bothersome migraine-associated symptom (MBS) other than a headache, in their first treated migraine attack (excluding the "run-in test" treatment). MBS may be nausea, photophobia, phonophobia or allodynia - as defined by each subject at the beginning of the treatment
Group
Value
95% CI
Treatment of Migraine With Active Device
44
Treatment of Migraine With Sham Device
22
Percentage of Participants With Reduced Migraine Headache AND MBS Relief at 2 Hours Post TreatmentSecondary· 2 hours post migraine onset
The percentage of patients reporting, 2 hours post treatment response to both the primary and the first secondary endpoints
Group
Value
95% CI
Treatment of Migraine With Active Device
38
Treatment of Migraine With Sham Device
15
Percentage of Participants With Pain Disappearance at 2 Hours Post TreatmentSecondary· 2 hours post migraine onset
The percentage of subjects reporting freedom from migraine pain at 2 hours post-treatment without medications in their first treated migraine attack
Group
Value
95% CI
Treatment of Migraine With Active Device
37
Treatment of Migraine With Sham Device
19
Number of Adverse Events Related or Unrelated to the Study DeviceSecondary· up to 14 weeks
The number of Adverse events related to the study device. Safety analyses were performed on all participants from the ITT population (126 participants in each group).
Group
Value
95% CI
Treatment of Migraine With Active Device
14
Treatment of Migraine With Sham Device
9
Within-patient Consistency - Percentage of Participants With Reduction in Headache Pain in at Least 50% of Their TreatmentsSecondary· up to 6 weeks
The repeatability of migraine headache reduction, as described in the primary endpoint definition, in subsequent treated attacks. Thus, this endpoint measures the % of patient responding to the primary endpoint in at least 50% of their treated attacks (excluding the run-in attack
Group
Value
95% CI
Treatment of Migraine With Active Device
51.3
42.8 – 61.4
Treatment of Migraine With Sham Device
38.1
31.2 – 46.6
Percentage of Participants With Sustained Pain-free 48 Hours With Single Use of the DeviceSecondary· 48 hours post treatment
The proportion (%) of subjects reporting pain-free at 2 hours, and no return of any pain or use of rescue/acute medication, or reuse of device between 2 hours and 48 hours, in their first treated migraine attack
Group
Value
95% CI
Treatment of Migraine With Active Device
18
Treatment of Migraine With Sham Device
6
Percentage of Participants With Sustained Headache Reduction for 48 Hours With Single Use of the DeviceSecondary· 48 hours post treatment
The proportion (%) of subjects reporting treatment response 2 hours post-treatment without rescue medications, and no return to baseline level of pain at time of treatment, or use of rescue/acute medication, or reuse of device between 2 hours and 48 hours, in their first treated migraine attack
Group
Value
95% CI
Treatment of Migraine With Active Device
32
Treatment of Migraine With Sham Device
14
Adverse events — posted to ClinicalTrials.gov
Time frame: up to 14 weeks.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Migraine is a common neurologic with attacks of headache and associated symptoms such as nausea, vomiting, phono and photophobia. Migraine can lead to substantial functional impairment.
Recent evidence suggests that electro stimulation is effective in providing relief for chronic headaches including migraine. It is tolerable by patients and associated with no adverse effects.
The device utilizes electro stimulation to achieve conditioned pain modulation (CPM). CPM an stimulate endogenous analgesic mechanism. The modulatory effect is over the whole body, and can be induced anywhere.
This is a prospective, randomized, double-blind, sham controlled multi-center trial. Ratio between treatment and control groups will be 1:1, stratified by center and use of preventive medications.
The study objectives is to demonstrate the safety and effectiveness of the Nerivio Migra electro stimulation device for the reduction of migraine headache during an attack of migraine with or without aura.
The study is intended for subject with 2-8 migraine episodes per month. patients will receive the device, either an active or a placebo type, and will be asked to use the device at home or in any location that they will be when the migraine starts.
The study hypothesis is that electro stimulation delivered transcutaneously to the peripheral nervous system at onset of a migraine attack significantly reduce headache pain demonstrated by a significant difference between proportions of responders to the active treatment stimulation in comparison to proportion of responders that will use a placebo device.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Theranica
Last refreshed: 19 May 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03361423.