gammaCore Clinical Studies

2 studies demonstrated the safety and effectiveness of gammaCore
The gammaCore model shown is not currently available in the US.
ACT1 Study
RAPID, SUSTAINED RELIEF OF EPISODIC CLUSTER HEADACHE PAIN

Response in First Treated Attack (Primary Endpoint): All Study Groups1,2

  • Significantly more episodic cluster headache patients responded with gammaCore for the first treated cluster attack vs those receiving sham (response = reporting "mild pain" or "no pain" at 15 minutes)1,2
Study design: Prospective, randomized, double-blind, sham-controlled clinical study that included 150 total patients: 101 with episodic cluster headache and 49 with chronic cluster headache. The primary endpoint was the percentage of patients who reported "mild pain" or "no pain" 15 minutes after treatment initiation with gammaCore for the first treated attack. Pain intensity was scored on a 0-4 scale, with 0 being “no pain” and 4 being “very severe pain.”1,2

Episodic Cluster Headache Patients Successfully Treated More Than 50% of Attacks1,2

  • Significantly more episodic cluster headache patients responded to gammaCore for ≥50% of all treated attacks vs those receiving sham1,2

Significant Reduction in Duration of Attacks in Episodic Cluster Headache Patients1,2*

  • Episodic cluster headache patients treated with gammaCore also had a significantly greater mean reduction in the duration of treated attacks vs those treated with sham, who had an increase in attack duration1,2
*Based on available patient data.

gammaCore was safe and well tolerated1,2
  • Most adverse events were mild and transient, occurred during gammaCore dosing, and then went away
  • No serious gammaCore-related adverse events occurred
  • The only side effect that occurred in ≥5% of subjects using gammaCore was “lip or facial drooping/pulling/twitching,” which is also a sign that the device is likely positioned correctly on the neck


ACT2 Study
RELIABLE RELIEF FOR EPISODIC CLUSTER HEADACHE PAIN

Percentage of All Attacks That Were Pain-Free at 15 Minutes (Primary Endpoint): All Study Groups2

  • Significantly more episodic cluster attacks treated with gammaCore were pain-free at 15 minutes vs those treated with sham2
Study design: Prospective, randomized, double-blind, sham-controlled clinical study that included 102 total patients: 30 with episodic cluster headache and 72 with chronic cluster headache. The primary endpoint was the percentage of total attacks that were pain-free 15 minutes after the initiation of gammaCore, with no use of rescue medication through the treatment period (30 minutes). Pain intensity was scored on a 0-4 scale, with 0 being "no pain" and 4 being "very severe pain." Patients treated themselves at the onset of pain, with the option to repeat the treatment approximately 9 minutes after the onset of pain (3 minutes after the first treatment).2

Episodic Cluster Headache Patients Successfully Treated More Than 50% of Attacks2*

  • Significantly more episodic cluster headache patients treated with gammaCore responded within 30 minutes in ≥50% of treated attacks vs those treated with sham2
*Response defined as "no pain" or "mild pain" at 30 minutes.

Significant Reduction in Pain Intensity Across All Treated Attacks in Episodic Cluster Headache Patients2,3

  • Episodic cluster headache patients treated with gammaCore also reported significantly greater reduction in pain intensity at 15 minutes vs those treated with sham2,3

gammaCore was safe and well tolerated2
  • Most adverse events were mild and transient, occurred during gammaCore dosing, and then went away
  • No gammaCore-related adverse events occurred in ≥5% of subjects
  • No serious gammaCore-related adverse events occurred
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.

About gammaCore
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How gammaCore Works
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References

  1. 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.
  2. gammaCore Instructions for Use. Basking Ridge, NJ: electroCore; 2017.
  3. Data on file, electroCore.