electroCore, a neuroscience and technology company dedicated to improving patient outcomes through technological advancement, today announced new data from the ACT (Non–Invasive Vagus Nerve Stimulation for the ACute Treatment of Cluster Headache) clinical trial program demonstrating the safety and efficacy of gammaCore® (non-invasive vagus nerve stimulator) as an acute treatment for patients with episodic cluster headache (eCH) at the 59th Annual Scientific Meeting of the American Headache Society (AHS). Results of the pooled analysis, “Non-invasive Vagus Nerve Stimulation for Acute Treatment of Episodic and Chronic Cluster Headache: Pooled Analysis of Data From Two Randomized, Double-blind, Sham-Controlled Clinical Trials” (AHS Abstract #IOR3), will be presented on Saturday, June 10th as a late-breaking oral abstract.
“The findings from this pooled analysis of ACT1 and ACT2 are exciting,” said Professor Peter Goadsby, MD, PhD, Professor of Neurology, King’s College London and Director, NIHR-Wellcome Trust Clinical Research Facility, King’s College Hospital, London. “The data not only reinforces the safety and efficacy of gammaCore but also highlights some of the important advantages of non-invasive vagus nerve stimulation over existing treatment options, such as ease-of-use and the ability to be employed for multiple attacks a day.”
This new pooled analysis of data from ACT1 and ACT2 evaluated the safety and efficacy of gammaCore as an acute treatment for more than 250 patients with cluster headache (eCH or cCH). The proportion of patients who achieved mild or no pain at 15 minutes after treatment initiation for the first treated cluster attack (the ACT1 primary end point) was significantly greater in eCH patients treated with gammaCore versus sham for both ACT1 (34% vs. 11%; p = 0.01) and the pooled analysis (39% vs. 12%; p < 0.01), but not for ACT2 (50% vs. 15%; p = 0.07). The proportion of all treated attacks that achieved pain-free status at 15 minutes after treatment initiation (the ACT2 primary end point) was significantly greater in eCH patients treated with gammaCore versus sham for ACT1 (15% vs. 6%; p < 0.05), ACT2 (35% vs. 7%; p < 0.05), and the pooled analysis (24% vs. 7%; p < 0.01). There were no significant treatment differences for either of these end points in the total cluster headache population or the cCH population for ACT1, ACT2, or the pooled analysis. No serious adverse device effects were reported.
Additional results from the ACT2 trial, “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” (AHS Abstract #PS78), will be presented as a poster at the meeting. The trial found that the proportion of all attacks that achieved pain-free status at 15 minutes (primary end point) was superior for those using gammaCore versus sham (47.5% vs. 6.2%; p < 0.01) in the eCH cohort. In the cCH cohort, no treatment difference was shown (gammaCore, 4.8%; sham, 12.9%). Results from this trial were first presented during an Emerging Science Session at the American Academy of Neurology (AAN) Annual Meeting on April 25, 2017.
The U.S. Food and Drug Administration released gammaCore on April 14, 2017 for the acute treatment of pain associated with eCH in adult patients. Commercial availability in the U.S. is expected early in the third quarter of 2017.