Clinical Efficacy

Consider gammaCore: a promising, new treatment option

Episodic cluster headache is a debilitating condition that’s hard to treat.1 Those who suffer from episodic cluster headache have periods of time when they have multiple attacks per day. The pain quickly becomes extremely severe or unbearable and can last from 15 to 180 minutes.2

Despite the current treatments available for cluster headache pain, many patients are dissatisfied with the current options and are looking for new, effective treatments.3

gammaCore circles

gammaCore is proven safe and effective4,5

In 2 clinical trials, gammaCore (nVNS) demonstrated:

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Fast relief 
from the first attack

Icon of relief across mutiple attacks

Reliable relief across multiple attacks

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Reduction in the duration and intensity of attacks

One of the largest clinical programs conducted for cluster headache pain4

Two randomized, double-blind, sham-controlled clinical studies included patients with episodic cluster headache (eCH) and chronic cluster headache (cCH). Pain intensity was scored on a 0-4 scale, with 0 being “no pain” and 4 being “very severe pain.”4,5

  • 150 cluster headache patients (101 eCH, 49 cCH)
  • Primary endpoint was the percentage of people who reported “mild pain” or “no pain” 15 minutes after using gammaCore to treat their first attack
  • Patients were instructed to treat their attack at the onset of pain with 3 two-minute stimulations4,5
  • 102 cluster headache patients (30 eCH, 72 cCH)
  • Primary endpoint was the percentage of total attacks that were pain-free 15 minutes after using gammaCore
  • Patients were instructed to treat their attack at the onset of pain with 3 two-minute stimulations (they could administer 3 additional two-minute stimulations if pain persisted)5

Fast relief from the first treated attack4,5

gammaCore provided significantly greater relief at 15 minutes vs sham

Response in First Treated Attack at 15 Minutes (Primary Endpoint): All Study Groups4,5

Image of fast relief chart from ACT1
  • Significantly more episodic cluster headache patients responded with gammaCore for the first treated cluster attack vs those receiving sham (response = reporting “mild” or “no pain” at 15 minutes)4,5

Percentage of All Treated Attacks That Were Pain-Free at 15 Minutes (Primary Endpoint): All Study Groups5

Image of fast relief chart from ACT2

  • Among episodic cluster headache patients, significantly more attacks treated with gammaCore were pain-free at 15 minutes vs those treated with sham5

NOTE: While the clinical studies included patients with chronic cluster headache, gammaCore is indicated for the acute treatment of pain associated with episodic cluster headache in adult patients.

Reliable relief across multiple attacks4-6

gammaCore provided reliable relief for more patients vs sham

Episodic Cluster Headache Patients Successfully Treated ≥50% of Attacks4,5*

Image of reliable relief from ACT1

*Response defined as “no pain” or “mild pain” at 15 minutes.

  • Significantly more episodic cluster headache patients responded to gammaCore at 15 minutes for ≥50% of all treated attacks vs those receiving sham4,5

Episodic Cluster Headache Patients Successfully Treated ≥50% of Attacks6‡

Image of reliable relief from ACT2

‡Response defined as "no pain" or "mild pain" at 15 minutes.

  • Significantly more episodic cluster headache patients treated with gammaCore responded within 15 minutes in ≥50% of treated attacks vs those treated with sham6

Reduction in the duration and intensity of attacks4,5

gammaCore decreased the length and the severity of attacks vs sham

Significant Reduction in Duration of First Treated Attack in Episodic Cluster Headache Patients4,5*

Image of chart of reduction in duration of attacks

*Based on available patient data.

  • Episodic cluster headache patients treated with gammaCore also had a significantly greater mean reduction in the duration of the first treated attack vs those treated with sham, who had an increase in attack duration4,5

Significant Reduction in Pain Intensity Across All Treated Attacks in Episodic Cluster Headache Patients5‡

Image of chart of reduction in intensity of attacks

‡Mean of all attacks per patient.

  • Episodic cluster headache patients treated with gammaCore also reported significantly greater reduction in pain intensity at 15 minutes vs those treated with sham5

NOTE: While the clinical studies included patients with chronic cluster headache, gammaCore is indicated for the acute treatment of pain associated with episodic cluster headache in adult patients.

References: 1. Robbins MS, Starling AJ, Pringsheim TM, Becker WJ, Schwedt TJ. Treatment of cluster headache: the American Headache Society evidence-based guidelines. Headache. 2016;56(7):1093-1106. 2. Rossi P, Whelan J, Craven A, Ruiz De La Torre E. What is cluster headache? Fact sheet for patients and their families. A publication to mark Cluster Headache Day 2016. Funct Neurol. 2016;31(3):181-183. 3. Data on file, electroCore, LLC. 4. Silberstein SD, Mechtler LL, Kudrow DB, et al; ACT1 Study Group. Non-invasive vagus nerve stimulation for the acute treatment of cluster headache: findings from the randomized, double-blind, sham-controlled ACT1 study. Headache. 2016;56(8):1317-1332. 5. gammaCore Instructions for Use. Basking Ridge, NJ: electroCore, LLC; 2017. 6. Goadsby P, de Coo I, Silver N, et al. Non-invasive vagus nerve stimulation for the acute treatment of episodic and chronic cluster headache: findings from the randomized, double-blind, sham-controlled ACT2 study. Presented at: American Academy of Neurology 2017 Annual Meeting; April 22-28, 2017; Boston, MA. Abstract 002.