Non-invasive vagus nerve stimulation (nVNS) for the preventive treatment of episodic migraine: The multicentre, double-blind, randomised, sham-controlled PREMIUM trial

Author:

Diener Hans-Christoph1,Goadsby Peter J2ORCID,Ashina Messoud3,Al-Karagholi Mohammad Al-Mahdi3ORCID,Sinclair Alexandra4,Mitsikostas Dimos5,Magis Delphine6ORCID,Pozo-Rosich Patricia78,Irimia Sieira Pablo9,Làinez Miguel JA10,Gaul Charly11,Silver Nicholas12,Hoffmann Jan2ORCID,Marin Juana2,Liebler Eric13,Ferrari Michel D14

Affiliation:

1. Faculty of Medicine, University Duisburg-Essen, Essen, Germany

2. NIHR-Wellcome Trust King's Clinical Research Facility, King's College London, London, UK

3. Danish Headache Center, Rigshospitalet Glostrup, University of Copenhagen, Copenhagen, Denmark

4. Metabolic Neurology, Institute of Metabolism and Systems Research, University of Birmingham, Birmingham, UK

5. 1st Neurology Department, Aeginition Hospital, National and Kapodistrian University of Athens, Athens, Greece

6. Neurology Department and Pain Clinic, CHR East Belgium, Liège, Belgium

7. Headache Unit, Neurology Department, Hospital Universitari Vall d'Hebron, Barcelona, Spain

8. Headache Research Group, Vall d'Hebron Research Institute, Universitat Autonoma de Barcelona, Barcelona, Spain

9. Clinica Universidad de Navarra, Pamplona, Spain

10. Catholic University of Valencia, University Clinic Hospital, Valencia, Spain

11. Migraine and Headache Clinic, Königstein, Germany

12. The Walton Centre, Liverpool, UK

13. electroCore, Inc., Basking Ridge, New Jersey, USA

14. Leiden University Medical Center, Leiden, The Netherlands

Abstract

Introduction Non-invasive vagus nerve stimulation (nVNS; gammaCore®) has the potential to prevent migraine days in patients with migraine on the basis of mechanistic rationale and pilot clinical data. Methods This multicentre study included a 4-week run-in period, a 12-week double-blind period of randomised treatment with nVNS or sham, and a 24-week open-label period of nVNS. Patients were to administer two 120-second stimulations bilaterally to the neck three times daily (6–8 hours apart). Results Of 477 enrolled patients, 332 comprised the intent-to-treat (ITT) population. Mean reductions in migraine days per month (primary outcome) were 2.26 for nVNS (n = 165; baseline, 7.9 days) and 1.80 for sham (n = 167; baseline, 8.1 days) ( p = 0.15). Results were similar across other outcomes. Upon observation of suboptimal adherence rates, post hoc analysis of patients with ≥ 67% adherence per month demonstrated significant differences between nVNS (n = 138) and sham (n = 140) for outcomes including reduction in migraine days (2.27 vs. 1.53; p = 0.043); therapeutic gains were greater in patients with aura than in those without aura. Most nVNS device-related adverse events were mild and transient, with application site discomfort being the most common. Conclusions Preventive nVNS treatment in episodic migraine was not superior to sham stimulation in the ITT population. The “sham” device inadvertently provided a level of active vagus nerve stimulation. Post hoc analysis showed significant effects of nVNS in treatment-adherent patients. Study identification and registration: PREMIUM; NCT02378844; https://clinicaltrials.gov/ct2/show/NCT02378844

Funder

electroCore, Inc.

Publisher

SAGE Publications

Subject

Clinical Neurology,General Medicine

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