Randomized Controlled Study of Non-invasive Vagus Nerve Stimulation (nVNS) for the Acute Treatment of Migraine: The PRESTO Trial (S43.005)

Cristina Tassorelli, Licia Grazzi, Marina De Tommaso, Giulia Pierangeli, Paolo Martelletti, Innocenzo Rainero, Pierangelo Geppetti, Anna Ambrosini, Paola Sarchielli, Eric Liebler, Piero Barbanti

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Abstract

Objective: Evaluate non-invasive vagus nerve stimulation (nVNS; gammaCore®) for the acute treatment of migraine in a multicenter, double-blind, randomized, sham-controlled trial.Background: nVNS is easy to use, flexible, and well tolerated, making it an attractive option for patients. Its safety, tolerability, and preliminary efficacy have been suggested in pilot studies of migraine.Design/Methods: Patients with episodic migraine with or without aura (N=248) were recruited from 10 Italian tertiary headache centers. Entry criteria and efficacy measures were consistent with existing guidelines and previous nVNS studies. For up to 5 migraine attacks, patients self-administered two 120-second stimulations bilaterally to the neck within 20 minutes of migraine pain onset. If pain did not improve at 15 minutes post treatment, patients were instructed to repeat both stimulations; a third set of optional stimulations was administered by those who were not pain-free at 120 minutes. Rescue medication use before 120 minutes was considered a treatment failure.Results: Acute nVNS treatment (n=120) led to significantly higher pain-free rates than sham (n=123) for the first treated migraine attack at 30 minutes (12.7% vs 4.2%; P=0.012) and 60 minutes (21.0% vs 10.0%; P=0.023) but not at 120 minutes (30.4% vs 19.7%; P=0.067; primary end point; sensitivity analysis). A post hoc repeated-measures test performed to address the time-dependent findings confirmed that nVNS was superior to sham through 120 minutes (odds ratio: 2.3; 95% CI: 1.2, 4.4; P=0.012). Results also favored nVNS for the rate of mild/no pain at 120 minutes (40.8% vs 27.6%; P=0.030) and 50% responder rates for no pain (32.4% vs 18.2%; P=0.020) and mild/no pain (47.6% vs 32.3%; P=0.026). Adverse effects of nVNS were infrequent and mostly mild and transient.Conclusions: This randomized sham-controlled trial supports the use of nVNS as a rapidly effective, well-tolerated, and practical option for the acute treatment of episodic migraine.Disclosure: Dr. Tassorelli has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Prof. Tassorelli has received consultancy fees from Allergan S.p.A. and electroCore, LLC, and research grants from the European Commission and the Italian Ministry of Health. She is also a principal investigator or collaborator for RCTs sponsored by Alder. Dr. Grazzi has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Dr. Grazzi has received consultancy and advisory fees from Allergan S.p.A. and electroCore, LLC. Dr. De Tommaso has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Prof. de Tommaso has received advisory fees from Allergan S.p.A., Neopharmed, and Pfizer Inc. Dr. Pierangeli has nothing to disclose. Dr. Martelletti has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Prof. Martelletti has received research grants, advisory board fees, or travel fees from ACRAF, Allergan S.p.A., Amgen Inc., electroCore, LLC, Novartis AG, and Teva Pharmaceutical Industries Ltd. Dr. Martelletti has received personal compensation in an editorial capacity for The Journal of Headache and Pain. Dr. Martelletti has received research support from Prof. Martelletti has received research grants, advisory board fees, or travel fees from ACRAF, Allergan S.p.A., Amgen Inc., electroCore, LLC, Novartis AG, and Teva Pharmaceutical Industries Ltd. Dr. Rainero has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Prof. Rainero has received consultancy fees from electroCore, LLC, and Mylan N.V. and research grants from the European Commission — Horizon 2020. He is also a principal investigator for RCTs sponsored by Axovant Sciences Ltd. and TauRx Pharmaceuticals Lt. Dr. Geppetti has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Prof. Geppetti has received consultancy fees from Allergan S.p.A., electroCore, LLC, Evidera, Novartis AG, Pfizer Inc., and Sanofi S.p.A. and research grants from Chiesi Farmaceutici S.p.A. He is also a principal investigator for RCTs sponsored by Eli Lil. Dr. Geppetti has received research support from Prof. Geppetti has received consultancy fees from Allergan S.p.A., electroCore, LLC, Evidera, Novartis AG, Pfizer Inc., and Sanofi S.p.A. and research grants from Chiesi Farmaceutici S.p.A. He is also a principal investigator for RCTs sponsored by Eli Lil. Dr. Ambrosini has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Dr. Ambrosini has received consultancy fees from Almirall, S.A., and travel grants from Allergan S.p.A. and Almirall, S.A. Dr. Sarchielli has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Prof. Sarchielli has received clinical study fees from Allergan S.p.A. Dr. Liebler has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Mr. Liebler is an employee of electroCore, LLC, and receives stock ownership. Dr. Liebler has received compensation for serving on the Board of Directors of Mr. Liebler is an employee of electroCore, LLC, and receives stock ownership. Dr. Barbanti has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Prof. Barbanti has received consultancy fees from Allergan S.p.A., electroCore, LLC, Janssen Pharmaceuticals, Inc., Lusofarmaco, and Visufarma and advisory fees from Abbott Laboratories and Merck & Co., Inc.
Original languageEnglish
JournalNeurology
Volume90
Issue number15 Supplement
Publication statusPublished - Apr 10 2018

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