Assessment of Safety and Efficacy of Nerivio for the Migraine Prevention

A Prospective, Randomized, Double-blind, Sham-controlled Multi-center Clinical Study Assessing the Safety and Efficacy of Nerivio for the Preventive Treatment of Migraine

Sponsors

Commanditaire principal: Theranica

La source Theranica
Bref résumé

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 Nwrivio 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).

Description détaillée

Nerivio is a neuromodulation device approved for the acute treatment of migraine with or without aura in patients 12 years of age or older. The device utilizes electro stimulation to achieve conditioned pain modulation (CPM). CPM stimulate endogenous analgesic mechanism. Treatments are self-administered by the user at the onset of a migraine attack. this study intends to demonstrate the safety and efficacy of the Nwrivio for migraine prevention. The study is a prospective, randomized, double-blind, sham-controlled, multicenter trial, conducted in three phases. The ratio between treatment and control groups will be 1:1, stratified by center and patient type (chronic/non-chronic). The study will consist of a screening/enrollment visit, followed by a 4-week (28 days) baseline phase. Eligible participants will enter an 8-week double-blind preventive treatment phase. Following the preventive treatment phase, patients will be offered to participate in a 4-week open-label pre-emptive treatment phase or continue their prevention treatment with an active device, according to their eligibility. 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 Phase I - Baseline - 4 weeks (weeks 1 through 4): Eligible participants will install the Nerivio app on their smartphones and will be instructed to record daily their migraine/headaches symptoms and medication use on the Nerivio app. Transition to the treatment phase: Participants who meet the following criteria in the baseline phase will be eligible to continue to the treatment phase: - Complete the diary in at least 22 out of the 28 days during the baseline phase (80%) - Have between 6 to 24 headache days during the 28-day baseline period - At least 4 of their headache days during the baseline phase fulfill the ICHD-3 criteria for migraine (migraine without aura [code 1.1; C and D] or with aura [code 1.2; B and C], or probable migraine, or headaches requiring the use of migraine-specific medications including triptans, gepants or ergot derivatives). Phase II - treatment phase (prevention) - 8 weeks (weeks 5 through 12): Participants who meet the baseline phase requirements will be randomized in a 1:1 ratio to active and sham groups. Participants will be instructed to complete a daily diary (in the Nerivio app) about their headaches, associated symptoms, and medication use. They will also be instructed to conduct a 45-minute treatment with Nerivio every other day. Transition to the follow-up phase (open label): At the end of the treatment phase, participants from both arms (active and sham) may continue to a follow-up phase in which they will receive an active device that can be used during this phase. The data of all participants will be used for safety analyses. The data of participants from the baseline and treatment phases will be used to assess their eligibility to participate in the pre-emptive follow-up phase. Participants eligible for the follow-up phase meet the following conditions: - Between 6-16 headache days during the baseline phase. - Participants experience prodrome symptoms within 24 hours prior to the onset of their migraine headache in at least half of their migraine attacks during the baseline phase. - Participants completed the daily questionnaires in at least 70% of the days during the treatment phase. - Treated every other day in at least 24 and less than 33 days during the 56 days of the treatment phase. All adverse events will be reported. Phase III - Follow-up phase (open label) - 4 weeks (weeks 13 through 16): All participants will receive an active Nerivio device to use during the follow-up phase. Participants who do not meet the above requirements will be able to enter into the safety follow-up and continue to use Nerivio every other day for the preventive treatment of migraine. They will be instructed to compete a daily diary as was done in the treatment phase. Participants who meet the above requirements will enter the pre-emptive follow-up phase and be instructed to conduct a 45-minute device treatment within 60 minutes of prodrome symptom onset. Participants will be instructed to complete questionnaires regarding their headache, prodrome symptoms, and medication use at baseline (start of treatment), 2 hours post-treatment, and 24 hours post-treatment. In addition, participants will be instructed to continue to report the daily diary, as performed in the other phases of the study. All adverse events will be reported.

Situation globale Not yet recruiting
Date de début 2021-04-10
Date d'achèvement 2022-04-30
Date d'achèvement principale 2022-01-31
Phase N/A
Type d'étude Interventional
Résultat primaire
Mesure Plage de temps
Reduction in headache days 3 months
Rate of Adverse events (Safety and Tolerability) 3 months
Résultat secondaire
Mesure Plage de temps
Reduction in moderate/severe headache days 3 months
Reduction of 30% in headache days 3 months
Reduction of 50% in headache days 3 months
Reduction in HIT score 3 months
Reduction in MSQ score 3 months
Inscription 300
État
Intervention

Type d'intervention: Device

Nom de l'intervention: Nerivio active device

La description: Nerivio neurostimulator of conditional pain modulation (CPM)

Étiquette du groupe d'armements: Migraine prevention treatment with active Nerivio

Type d'intervention: Device

Nom de l'intervention: Nerivio sham device

La description: Nerivio neurostimulator with an electrical output not intended for neurostimulation

Étiquette du groupe d'armements: Migraine prevention treatment with sham Nerivio

Admissibilité

Critères:

Inclusion Criteria: 1. Age 18-75 years old. 2. 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 HA/ month with migraine days (migraine with and without aura) at least 8 days/ month for > 3 months) or non-chronic migraine. 3. History of 6 to 24 headache days per 28-day period for each of the 3 months preceding study enrolment (based on participant report). 4. 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. 5. Have personal access to a smartphone (24/7). 6. Must be able and willing to comply with the protocol. 7. Must be able and willing to provide informed consent.. Exclusion Criteria: 1. An active implanted electrical and/or neurostimulator device (e.g. cardiac pacemaker, cochlear implant). 2. Uncontrolled epilepsy. 3. History of use of opioids or barbiturates on more than 4 days a month in the last 6 months. 4. Current participation in any other interventional clinical study 5. Subject without basic cognitive and motor skills required for operating a smartphone. 6. Pregnant or breastfeeding. 7. Other significant pain, medical or psychological problems that in the opinion of the investigator may confound the study assessments. 8. Prior experience with the Nerivio device.

Le sexe: All

Âge minimum: 18 Years

Âge maximum: 75 Years

Volontaires en santé: No

Officiel général
Nom de famille Rôle Affiliation
Robert Cowan, MD Study Chair Stanford Health Care
Contact général

Nom de famille: Dagan Harris, PhD

Téléphone: +97272 3909755

Email: [email protected]

Emplacement
Établissement: Contact: Enquêteur:
The Neurology Center of Southern California | Carlsbad, California, 92011, United States April Tenorio [email protected] Jack Schim, MD Principal Investigator
Newport Beach Clinical Research Associates | Newport Beach, California, 92663, United States Ricky Cortes [email protected] Christopher O'Carroll, MD Principal Investigator
Hartford Headache Center | Hartford, Connecticut, 06107, United States Maria Veronesi [email protected] Brian Grosberg, MD Principal Investigator
RecioMed Clinical Research | Boynton Beach, Florida, 33472, United States Diana De La Torre [email protected] Brett Osborn, MD Principal Investigator
Chicago Headache Center and Research Institute | Chicago, Illinois, 60657, United States Melody Smith [email protected] Brad Torphy, MD Principal Investigator
Headache Neurology Research Institute | Ridgeland, Mississippi, 39157, United States Melissa Atkins [email protected] Christina Treppendahl, MHD Principal Investigator
Mercy Hospital St. Louis | Saint Louis, Missouri, 63141, United States Sandra Tilley [email protected] Jo Bonner, MD Principal Investigator
StudyMetrix Research | Saint Peters, Missouri, 63303, United States Sheri Rocco [email protected] Timothy Smith, MD Principal Investigator
ClinVest Research | Springfield, Missouri, 65810, United States Josh Devine [email protected] David True, MD Principal Investigator
DENT Neurosciences Research Center | Amherst, New York, 14226, United States Rebecca Hogan [email protected] Laszlo Mechtler, MD Principal Investigator
Pays d'implantation

United States

Date de vérification

2021-03-01

Partie responsable

Type: Sponsor

A un accès étendu No
Parcourir l'état
Nombre d'armes 2
Groupe d'armes

Étiquette: Migraine prevention treatment with active Nerivio

Type: Active Comparator

La description: Participants will treat with an active Nerivio device every other day for migraine prevention.

Étiquette: Migraine prevention treatment with sham Nerivio

Type: Sham Comparator

La description: Participants will treat with a sham (placebo) Nerivio device every other day for migraine prevention.

Données patient No
Informations sur la conception de l'étude

Allocation: Randomized

Modèle d'intervention: Parallel Assignment

Description du modèle d'intervention: Randomized, double-blind, sham-controlled

Objectif principal: Prevention

Masquage: Triple (Participant, Care Provider, Investigator)

La source: ClinicalTrials.gov

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