N/A
Completed N=248
Assessment of Safety and Efficacy of Nerivio for the Migraine Prevention
Source: ClinicalTrials.gov NCT04828707 ↗Enrolled (actual)
248
Serious AEs
0.8%
Results posted
Mar 2023
Primary outcomePrimary: Reduction in Migraine Days — -3.8; -1.1 Migraine days per month — p=<0.05
Summary
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. This study intends to demonstrate the safety and efficacy of the Nerivio for migraine prevention.
The study is a prospective, randomized, double-blind, sham-controlled, multicenter study, conducted in three phases.
The study will consist of a screening/enrollment visit, followed by a 4-week (28 days) baseline phase, an 8-week double-blind preventive treatment phase, and a 4-week open-label phase.
Patients will complete an electronic diary throughout the study; this includes a daily evening report (completed regardless of whether the patient had a headache) and treatment feedback during the follow-up pre-emptive phase.
The primary endpoint is the mean change in the average of migraine headache days per month comparing the 4-week baseline phase (weeks 1 through 4) with the last 28 days of the treatment phase (weeks 9 through 12).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Reduction in Migraine Days |
-3.8; -1.1 | <0.05 sig |
| PRIMARY Rate of Adverse Events (Safety and Tolerability) |
20; 21; 2; 0; 0; 1 | — |
| SECONDARY Reduction in Moderate/Severe Headache Days |
-3.5; -2.1 | — |
| SECONDARY Reduction Headache Days |
-4.2; -2.0 | — |
| SECONDARY Reduction of 50% in Headache Days |
40; 22 | — |
| SECONDARY Increase in Headache Impact Test-6 (HIT-6) Score at the End of the Last 28 Days (4 Weeks) of the Treatment Phase (Weeks 9 Through 12) Compare to the HIT-6 Score at the End of the 4-week Baseline Phase (Weeks 1 Through 4) |
4.7; 3.9 | — |
| SECONDARY Reduction in Migraine-Specific Quality-of-Life (MSQ) Questionnaire Score at the End of the Last 28 Days (4 Weeks) of the Treatment Phase (Weeks 9 Through 12) Compare to the MSQ Score at the End of the 4-week Baseline Phase (Weeks 1 Through 4) |
-11.5; -9.8 | — |
Eligibility Criteria
Inclusion Criteria
- Age 18-75 years old.
- Must have at least a 6-month history of headaches that meet the ICHD-3 diagnostic criteria for migraine with or without aura, either chronic (at least 15 days of Headache Days(HD)/ month with migraine days (migraine with or without aura) at least 8 days/ month for > 3 months) or non-chronic migraine.
- History of 6 to 24 headache days per 28-day period for each of the 3 months preceding study enrolment (based on participant report).
- Subject on prophylactic migraine treatment are permitted to remain on 1 medication with possible migraine-prophylactic effects if the dose has been stable for at least 2 months prior to the screening visit, and the dose is not expected to change during the course of the study.
- Have personal access to a smartphone (24/7).
- Must be able and willing to comply with the protocol.
- Must be able and willing to provide informed consent..
Exclusion Criteria
- An active implanted electrical and/or neurostimulator device (e.g. cardiac pacemaker, cochlear implant).
- Uncontrolled epilepsy.
- History of use of opioids or barbiturates on more than 4 days a month in the last 6 months.
- Current participation in any other interventional clinical study
- Subject without basic cognitive and motor skills required for operating a smartphone.
- Pregnant or breastfeeding.
- Other significant pain, medical or psychological problems that in the opinion of the investigator may confound the study assessments.
- Prior experience with the Nerivio device.
Data sourced from ClinicalTrials.gov (NCT04828707). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.