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Device

Migraine prevention treatment with active Nerivio for Migraine

N/A
Waitlist Available
Research Sponsored by Theranica
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights

Study Summary

This trial is designed to study the safety and effectiveness of a new drug, Nwrivio, for preventing migraines. The study will last for 16 weeks, and patients will complete an electronic diary throughout to document their progress. The primary endpoint is the mean change in the average of migraine headache days per month comparing the 4-week baseline phase with the last 28 days of the treatment phase.

Eligible Conditions
  • Migraine

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Rate of Adverse Events (Safety and Tolerability)
Reduction in Migraine Days
Secondary outcome measures
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)
Reduction Headache Days
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)
+2 more
Other outcome measures
Feasibility of Migraine Prediction Algorithm
Health Economic Analysis
Percentage of Freedom From Headache Post 2 Hours Following Prodrome Treatment
+3 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Migraine prevention treatment with active NerivioActive Control1 Intervention
Participants will treat with an active Nerivio device every other day for migraine prevention.
Group II: Migraine prevention treatment with sham NerivioPlacebo Group1 Intervention
Participants will treat with a sham (placebo) Nerivio device every other day for migraine prevention.

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Who is running the clinical trial?

TheranicaLead Sponsor
19 Previous Clinical Trials
40,607 Total Patients Enrolled
8 Trials studying Migraine
13,197 Patients Enrolled for Migraine
Robert Cowan, MDStudy ChairStanford Health Care

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Louisiana
How old are they?
18 - 65
What site did they apply to?
Headache Neurology Research Institute
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Assessment of Safety and Efficacy of Nerivio for the Migraine Prevention
2021. "Assessment of Safety and Efficacy of Nerivio for the Migraine Prevention". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04828707.
~84 spots leftby Apr 2025
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