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electroCore Announces Full Enrollment of TR-VENUS study of Non-Invasive Vagal Nerve Stimulation (nVNS) for the Acute Treatment of StrokeROCKAWAY, N.J., Feb. 02, 2021 (GLOBE NEWSWIRE) -- electroCore, Inc. (Nasdaq: ECOR), a commercial-stage bioelectronic medicine company, today announced that full enrollment has been achieved for the TR-VENUS study of non-invasive vagal nerve stimulation (nVNS) for the acute treatment of stroke. TR-VENUS is a double blind, randomized, sham-controlled, multi-center clinical trial, conducted at nine major medical centers across Turkey, supported by the Turkish Neurological Society and partially funded through an unrestricted research grant from electroCore. Stroke is the second highest cause of death and the third leading cause of disability globally . Ischemic stroke, caused by arterial occlusion, is the most common type of stroke. The effectiveness of current management strategies (e.g. rapid reperfusion with intravenous thrombolysis and endovascular thrombectomy) is dependent on time to treatment. Treating stroke quickly and safely is imperative for maximizing the therapeutic benefits of therapy. electroCore’s small and portable nVNS device, gammaCore Sapphire, offers the opportunity for administration rapidly after the onset of stroke. The scientific hypothesis supporting the TR-VENUS study is based, in part, on preclinical evidence from studies conducted in the lab of Ilknur Ay at Massachusetts General Hospital, Harvard Medical School suggesting that vagus nerve stimulation (VNS) results in a protective effect against ischemic brain injury1. The TR-VENUS study recruited a total of 60 subjects with ischemic stroke and eight subjects with hemorrhagic stroke. The primary objective was to assess the safety of nVNS in the setting of acute stroke by examining decreases in arterial blood pressure, severe bradycardia, progression of neurological deficits and death. Feasibility was also assessed by determining the proportion of allocated stimulation doses that could be administered. Secondary efficacy outcomes evaluated neurologic deficits and infarct growth. Top-line data will be reported once available and full results will be published in a peer reviewed medical journal later this year. The lead investigators of the study, Professors Ethem Murat Arsava and Mehmet Akif Topcuoglu of the Department of Neurology, Hacettepe University in Ankara, Turkey, commented, “We are very pleased to have successfully completed enrollment of this Phase 2 trial to assess the safety and feasibility of nVNS for the acute treatment of stroke. We are hopeful that nVNS might be a viable option to improve the treatment of acute stroke.” “We congratulate and thank the investigators, patients and families that all supported the successful completion of study enrollment and we look forward to the data readout and what it tells us about nVNS’ potential as an acute treatment for stroke,” said Eric Liebler, Senior Vice President of Neurology at electroCore. For complete details on the study design please see clintrials.gov: https://clinicaltrials.gov/ct2/show/NCT03733431?term=NCT03733431&draw=2&rank=1 About gammaCore™ gammaCore is FDA cleared in the United States for adjunctive use for the preventive treatment of cluster headache in adult patients, the acute treatment of pain associated with episodic cluster headache in adult patients, the acute treatment of pain associated with migraine headache in adult patients, and the prevention of migraine in adult patients. gammaCore is CE-marked in the European Union for the acute and/or prophylactic treatment of primary headache (Migraine, Cluster Headache, Trigeminal Autonomic Cephalalgias and Hemicrania Continua) and Medication veruse Headache in adults. In 2019, NICE published an evidence-based Medical Technology Guidance document recommending the use of gammaCore for cluster headache within NHS England.
In the US, the FDA has not cleared gammaCore for the treatment of pneumonia and/or respiratory disorders such as acute respiratory stress disorder associated with COVID-19. Please refer to the gammaCore Instructions for Use for all of the important warnings and precautions before using or prescribing this product. The United States FDA has authorized use of the gammaCore Sapphire CV device for acute use at home or in a healthcare setting to treat adult patients with known or suspected COVID-19 who are experiencing exacerbation of asthma-related dyspnea and reduced airflow, and for whom approved drug therapies are not tolerated or provide insufficient symptom relief as assessed by their healthcare provider, by using non-invasive vagus nerve stimulation (VNS) on either side of the patient’s neck, available under an emergency access mechanism called an EUA. gammaCore Sapphire CV has neither been cleared nor approved for acute use at home or in a healthcare setting to treat adult patients with known or suspected COVID-19 who are experiencing exacerbation of asthma-related dyspnea and reduced airflow, and for whom approved drug therapies are not tolerated or provide insufficient symptom relief as assessed by their healthcare provider, by using non-invasive Vagus nerve Stimulation (nVNS) on either side of the patient’s neck during the Coronavirus Disease 2019 (COVID-19) pandemic. gammaCore Sapphire CV has been authorized for the above emergency use by FDA under an Emergency Use Authorization. gammaCore Sapphire CV has been authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of medical devices under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked. Further information is available at: Authorization Letter: https://www.fda.gov/media/139967/download Fact Sheet for Healthcare Providers: https://www.fda.gov/media/139968/download Fact Sheet for Patients: https://www.fda.gov/media/139969/download Instructions for gammaCore use https://www.fda.gov/media/139970/download About electroCore, Inc. electroCore, Inc. is a commercial stage bioelectronic medicine company dedicated to improving patient outcomes through its platform non-invasive vagus nerve stimulation therapy initially focused on the treatment of multiple conditions in neurology. The company’s current indications are the preventative treatment of cluster headache and migraine and acute treatment of migraine and episodic cluster headache. For more information, visit www.electrocore.com. Forward-Looking Statement Investors: or Media Contact: 1 Ay I, Nasser R, Simon B, Ay H. Transcutaneous Cervical Vagus Nerve Stimulation Ameliorates Acute Ischemic Injury in Rats. Brain Stimul. 2016 Mar-Apr;9(2):166-73. doi: 10.1016/j.brs.2015.11.008. Epub 2015 Dec 1. PMID: 26723020; PMCID: PMC4789082. |