Efficacy and Safety of Nerivio Device for Acute Treatment of Migraine in People With Chronic Migraine

Completed · Not applicable

Conditions studied: Chronic Migraine

In brief

A prospective, single arm, open-label, multicenter trial to assess the efficacy and safety of the Nerivio device in chronic migraine patients. This study will be conducted in three phases: Phase I - Run-in: Eligible participants will be trained to use a smartphone migraine diary application. During the 4 weeks of this phase, participants will be instructed to report all their migraines and headaches at onset, 2 hours and 24 hours post report . Phase II - Treatment: A 4-week treatment phase in which participants will be asked to treat their migraine headaches with the Nerivio device and report it using the smartphone application at baseline, 2 hours and 24 hours post-treatment. Phase III - Follow-up: An 8-week follow-up phase in which participants will incorporate the Nerivio device into their usual care according to their preference (Nerivio only, medication only, both or none). Participants will be asked to report all their migraines or headaches at onset, 2 hours post report and 24 hours post report.

Key facts

Study ID

NCT04194008

Run by

Theranica

People needed

126

Starts

2019-11-18

Expected to finish

2020-08-30

Last updated by the study team

2021-02-02

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants aged 18-75 years old.
• Participants meeting the International Classification of Headache Disorders-3 (ICHD-3) diagnostic criteria for chronic migraine
• Participants experiencing between 15 to 23 headache days per month, with at least 8 headache days (per month) with migraine phenotype presentation
• Participants have personal access to a smartphone
• Participants must be able and willing to comply with the protocol
• Participants must be able and willing to provide written informed consent

You may not qualify if…

• Participants with an active implanted electrical and/or neurostimulator device (e.g. cardiac pacemaker, cochlear implant).
• Participants with congestive heart failure (CHF), severe cardiac or cerebrovascular disease.
• Participants with uncontrolled epilepsy.
• Lack of efficacy, after an adequate therapeutic trial, of at least two migraine specific acute medications.
• Change in migraine preventive medications (type or dose) in the last two months prior to recruitment and/or during the study
• Pregnant, trying to get pregnant or breastfeeding female participants
• Subjects participating in any other interventional clinical study.
• Participants without basic cognitive and/or motor skills needed to operate a smartphone
• Participants with other significant pain, medical or psychological problems that in the opinion of the investigator may confound the study assessments
• Participants who have previous experience with the device

Where it is running

• Newport Beach Clinical Research Associates, Inc. — Newport Beach, California, United States
• California Medical Clinic for Headache — Santa Monica, California, United States
• Hartford Healthcare Center — Hartford, Connecticut, United States
• Headache Neurology Research Institute — Ridgeland, Mississippi, United States
• StudyMetrix Research, LLC — City of Saint Peters, Missouri, United States
• ClinVest — Springfield, Missouri, United States
• Mercy Hospital — St Louis, Missouri, United States
• Island Neurological — Plainview, New York, United States
• Preferred Primary Care Physicians, Inc. — Pittsburgh, Pennsylvania, United States
• Nashville neuroscience — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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