Assessment of Safety and Efficacy of Nerivio for the Migraine Prevention
Completed · Not applicable · Has a placebo group
Conditions studied: Migraine
In brief
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).
Key facts
- Study ID
- NCT04828707
- Run by
- Theranica
- People needed
- 335
- Starts
- 2021-04-13
- Expected to finish
- 2022-10-10
- Last updated by the study team
- 2023-03-15
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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..
You may not qualify if…
- 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.
Where it is running
- Evolve Clinical Research — Phoenix, Arizona, United States
- The Neurology Center of Southern California — Carlsbad, California, United States
- Newport Beach Clinical Research Associates — Newport Beach, California, United States
- Hartford Headache Center — Hartford, Connecticut, United States
- RecioMed Clinical Research — Boynton Beach, Florida, United States
- Beautiful Minds Clinical Research Center — Cutler Bay, Florida, United States
- Chicago Headache Center and Research Institute — Chicago, Illinois, United States
- Deaconess Clinic — Evansville, Indiana, United States
- Four Rivers Clinical Research — Paducah, Kentucky, United States
- Headache Neurology Research Institute — Ridgeland, Mississippi, United States
- StudyMetrix Research — City of Saint Peters, Missouri, United States
- ClinVest Research — Springfield, Missouri, United States
- Ocean medical research — Toms River, New Jersey, United States
- DENT Neurosciences Research Center — Amherst, New York, United States
- Prevention & Strengthening Solutions, Inc. — Columbia, South Carolina, United States
- West Virginia University Medicine — Morgantown, West Virginia, United States
Full record on ClinicalTrials.gov
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