TOPAZ Clinical Research in Apopka, FL is actively recruiting children and adolescents ages 6-17 for a new clinical research study evaluating the safety and effectiveness of an investigational migraine treatment. The World Health Organization classifies migraine as one of the 10 most disabling medical illnesses, which occurs in approximately four to 11 percent of elementary school-aged children and eight to 15 percent of high school-aged adolescents. This multicenter, placebo controlled, Phase 3 clinical trial is studying rimegepant as a potential acute treatment to help stop a migraine attack when it occurs.
Jessica Gutierrez, M.D., FAAP, pediatrician and Principal Investigator at TOPAZ Clinical Research, said, “Children/Adolescents and their parents may not realize that symptoms such as head pain, nausea and vomiting and sensitivity to light and sound may be migraine. Migraine can be debilitating in younger individuals and it often goes undiagnosed because they have a more difficult time understanding and expressing their pain. There are limited treatment options available for migraine for children and adolescents, so we are hopeful rimegepant may help them get relief and return more quickly to their daily lives.”
Jessica Gutierrez, M.D., FAAP, pediatrician and Principal Investigator at TOPAZ Clinical Research. Biohaven Pharmaceuticals
Clinicians at TOPAZ Clinical Research are now seeking eligible participants for the study. To enroll, participants must be between 6 and 17 years of age, have at least one migraine per month, and have at least a six-month history of migraine. For more information about participating in the study at TOPAZ Clinical Research, call 407-703-4342, or visit https://www.topazclinicalresearch.com/migraine.
TOPAZ Clinical Research is one of more than 90 sites in the U.S. participating in the study. The study is sponsored by New Haven-based Biohaven Pharmaceuticals. The study will enroll approximately 1,200 participants between the ages of 6 and 17 who will receive rimegepant or placebo for the investigational treatment of up to two migraine attacks of moderate to severe intensity. The effectiveness of rimegepant compared to placebo will be measured by freedom from pain at two hours post-dose.
Migraine brain image by Biohaven Pharmaceuticals
Migraine is a debilitating neurological disease that impacts nearly 40 million people in the United States. In younger individuals, usually those under 15 years of age, migraine attacks may be bi-lateral (felt on both sides of the head) or unilateral (felt on only one side of the head), and may be non-throbbing. The child may look ill and pale, may feel dizzy, have blurred vision, and fever. Nausea and vomiting are frequent, particularly in young children (defined as seven years of age). Individuals with migraine tend to avoid light (photophobia), noise (phonophobia), strong odors, and movement.
TOPAZ Clinical Research is helping to assist in the development of new medicines, treatments, and devices for medical conditions that affect us and our loved ones daily. By providing the members of our community the opportunity to participate in clinical research studies we are providing them with hope, control, and the advancement to scientific contributions. All Studies are sponsored by pharmaceutical companies so there is never a cost to you for any study-related procedures or products. Join us today and help us to advance medical science and the development of better medical treatments for patients everywhere.
rimegepant image by Biohaven Pharmaceuticals
Biohaven is a global commercial-stage biopharmaceutical company with a portfolio of innovative, best-in-class therapies to improve the lives of patients with debilitating neurological and neuropsychiatric diseases, including rare disorders. Biohaven's Neuroinnovation™ portfolio includes FDA-approved NURTEC® ODT (rimegepant) for the acute and preventive treatment of migraine (EMA-approved as VYDURA® for the acute treatment of migraine with or without aura, and prophylaxis of episodic migraine in adults who have at least four migraine attacks per month) and a broad pipeline of late-stage product candidates across five distinct mechanistic platforms: CGRP receptor antagonism for the acute and preventive treatment of migraine and other CGRP-mediated diseases; glutamate modulation for obsessive-compulsive disorder and spinocerebellar ataxia; myeloperoxidase (MPO) inhibition for amyotrophic lateral sclerosis; Kv7 ion channel activators for focal epilepsy and neuronal hyperexcitability, and myostatin inhibition for neuromuscular diseases. More information about Biohaven is available at www.biohavenpharma.com.
Sponsored by Biohaven Pharmaceuticals