Author(s): Goadsby P.J.; Marin J.; De Coo I.F.; Ferrari M.D.; Silver N.; Tyagi A.; Ahmed F.; Gaul C.; Jensen R.H.; Diener H.-C.; Straube A.; Liebler E.
Source: Journal of Headache and Pain; 2017; vol. 18 (no. 1)
Publication Date: 2017
Publication Type(s): Conference Abstract
Available at Journal of Headache and Pain – from SpringerLink – Medicine
Available at Journal of Headache and Pain – from Europe PubMed Central – Open Access
Available at Journal of Headache and Pain – from ProQuest (Hospital Premium Collection) – NHS Version
Available at Journal of Headache and Pain – from EBSCO (MEDLINE Complete)
Abstract:Background Non-invasive vagus nerve stimulation (nVNS; gammaCore) is a novel potential option for the acute and prophylactic treatment of cluster headache (CH). We aimed to evaluate the efficacy, safety, and tolerability of acute nVNS treatment in the sham-controlled ACT2 study of episodic CH (eCH) and chronic CH (cCH). Methods For the 2-week double-blind period, adults with CH were randomly assigned (1:1) to receive nVNS or sham treatment. Patients selfadministered 3 consecutive 120-second stimulations to the cervical branch of the vagus nerve at CH attack onset. A second set of 3 stimulations was permitted if an attack was not aborted (pain-free) within 9 minutes of treatment initiation. Patients were instructed to refrain from using rescue treatments for 15 minutes after treatment initiation. Results Across 9 EU sites, 102 patients (eCH, n=30; cCH, n=72) were randomly assigned to receive nVNS (n=50) or sham (n=52) treatment. The intent-to-treat population included 48 nVNS-treated patients (eCH, n=14; cCH, n=34) and 44 sham-treated patients (eCH, n=13; cCH, n=31). In the total cohort, percentages of treated attacks that were pain-free (pain score=0) at 15 minutes were not significantly different between groups (nVNS, 14%; sham, 12%; primary end point). Significant benefits of nVNS over sham were seen in the eCH subgroup (nVNS, 48%; sham, 6%; P=50% of treated attacks at 15 minutes was significantly higher with nVNS in the total cohort (nVNS, 40%; sham, 14%; P=1 adverse device effect (ADE; nVNS, 18%; sham, 19%); no serious ADEs were reported. Conclusions Acute nVNS treatment was superior to sham in the eCH subgroup but not in the cCH subgroup or total cohort, 71% of whom had cCH. These results confirm the efficacy and safety of acute nVNS treatment for eCH.