Assessment of Safety and Efficacy of Nerivio for the Migraine Prevention
Public ClinicalTrials.gov record NCT04828707. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Prospective, Randomized, Double-blind, Sham-controlled Multi-center Clinical Study Assessing the Safety and Efficacy of Nerivio for the Preventive Treatment of Migraine
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT04828707
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 335 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 13, 2021 (Actual)
- Primary completion
- Aug 31, 2022 (Actual)
- Completion
- Oct 10, 2022 (Actual)
- Last update posted
- Mar 15, 2023
2021 – 2022
United States locations
- U.S. sites
- 16
- U.S. states
- 13
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Evolve Clinical Research | Phoenix | Arizona | 85013 | — |
| The Neurology Center of Southern California | Carlsbad | California | 92011 | — |
| Newport Beach Clinical Research Associates | Newport Beach | California | 92663 | — |
| Hartford Headache Center | Hartford | Connecticut | 06107 | — |
| RecioMed Clinical Research | Boynton Beach | Florida | 33472 | — |
| Beautiful Minds Clinical Research Center | Cutler Bay | Florida | 33157 | — |
| Chicago Headache Center and Research Institute | Chicago | Illinois | 60657 | — |
| Deaconess Clinic | Evansville | Indiana | 47713 | — |
| Four Rivers Clinical Research | Paducah | Kentucky | 42001 | — |
| Headache Neurology Research Institute | Ridgeland | Mississippi | 39157 | — |
| StudyMetrix Research | City of Saint Peters | Missouri | 63303 | — |
| ClinVest Research | Springfield | Missouri | 65810 | — |
| Ocean medical research | Toms River | New Jersey | 08755 | — |
| DENT Neurosciences Research Center | Amherst | New York | 14226 | — |
| Prevention & Strengthening Solutions, Inc. | Columbia | South Carolina | 29203 | — |
| West Virginia University Medicine | Morgantown | West Virginia | 26506 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04828707, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 15, 2023 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04828707 live on ClinicalTrials.gov.