Overlook to conduct study to evaluate nasal spray for the treatment of primary headache disorders; patient enrollment has begun

SUMMIT — The Headache Center at Overlook Medical Center and Atlantic Neuroscience Institute has started recruiting patients for an observational study to assess the safety and tolerability of non-prescription, homeopathic severe headache and migraine nasal spray Ausanil® in the treatment of primary headache disorders, including migraine, cluster headache and severe tension headaches. The study will also examine several secondary outcomes: headache pain, functional outcome, time loss to headache and overall patient satisfaction.

“In clinical practice in pain management and neurology, we continuously see patients who are in need of effective headache treatment that provides rapid onset of relief without concern of potential long-term side effects or adverse drug interactions,” said Maria Alexianu, M.D., PhD, one of the study’s lead investigators at Overlook Medical Center. “In helping patients manage their treatment plan, we continuously work to offer viable new treatment options that are safe and effective. We are optimistic this study will provide additional support for the intranasal use of capsicum annuum for migraine and severe headache relief.”

For several decades, research has demonstrated that nasal administration of extracts from the oleoresin capsicum plant — chili pepper plant — such as capsaicin have successfully treated migraines and cluster headaches.

Acting locally in the nose, Ausanil is thought to work by the calcium-mediated desensitization of the trigeminal nerve and resultant depletion of calcitonin gene-related peptides, the “pain” neurotransmitters responsible for migraine pain. Reduction in the release of CGRP leads to a reduction in the swelling and inflammation of blood vessels that surround the brain—resulting in pain relief.

“For more than a year, Ausanil has been available to patients as a non-prescription treatment option for rapid relief of severe headaches and migraines, and we continue to receive positive feedback from users—many of whom have tried numerous medications, prescription and over-the-counter, to unsuccessfully alleviate their pain quickly and safely,” said Michele Harris, director of operations and marketing at VR1, Inc. “We recognize the treatment challenges millions of headache sufferers face, and aim to continue closely examining how Ausanil may meet their needs through clinical trials.”

Currently, Overlook Medical Center is recruiting patients for the study who are between 18 and 80 years of age, are being treated by a physician for primary headache disorder, have not used capsicum annuum as a headache treatment, and are willing to document their headache response. If you are interested in enrolling in this clinical trial, contact Dr. Seth Stoller at 908-522-2709 or seth.stoller@atlantichealth.org.