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Cedar Health Research in Dallas Recruiting Adolescent Migraine Patients for Clinical Trial

CEDAR HEALTH RESEARCH IS CURRENTLY RECRUITING MIGRAINE PATIENTS AGED 12-17 FOR A CLINICAL TRIAL EVALUATING THE SAFETY AND EFFECTIVENESS OF RIMEGEPANT FOR THE ACUTE TREATMENT OF MIGRAINE IN ADOLESCENTS

Rimegepant is FDA-Approved to Treat and Prevent Episodic Migraine in Adults 

Migraine Impacts Up to 11% of Elementary School-Age Children and Up to 15% of High School-Age Children

Cedar Health Research in Dallas, Texas, is actively recruiting migraine patients aged 12-17 for a new clinical research study evaluating the safety and effectiveness of an investigational migraine treatment in adolescents. The World Health Organization classifies migraine as one of the 10 most disabling medical illnesses and 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 an investigational acute treatment. Rimegepant is approved by the U.S. Food and Drug Administration (FDA) to treat and prevent episodic migraine in adults and marketed as NURTEC® ODT.

“Migraine can be debilitating in adolescents, but often goes undiagnosed because they have a more difficult time understanding and expressing their pain,” said Ezekiel Fink M.D., chief medical officer, principal investigator-neurology, Cedar Health Research. “Limited treatment options for migraine are available for adolescents today. Rimegepant has shown effectiveness as an acute treatment in adults with migraine, and we are hopeful it will also help adolescents get relief and return more quickly to their daily life.”

Clinicians at the Cedar Health Research are now seeking eligible participants for the study. To enroll, participants must be between age 12 and 17, 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 atCedar Health Research, call (214) 253-8192 or visitwww.pediatricmigrainestudy.com.

You can also find enrollment information here: https://www.cedarhealthresearch.com/find-a-trial/dfw-east-trials/#!/study/13.

Clinical Trial Details

Cedar Health Research is one of more than90 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 12 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.

About Migraine in Adolescents

Migraine is a debilitating neurological disease. 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.

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About Cedar Health Research

Cedar Health Research is a full-service clinical research site. Their technology solutions, powered by Aspen Insights, use artificial intelligence to match patients to clinical trials at a level of precision and speed not previously possible. Cedar Health Research’s mission is to transform the clinical research domain through effective adoption of innovative technologies in a research site network that produces data with integrity.

About Migraine

Nearly 40 million people in the U.S. suffer from migraine and the World Health Organization classifies migraine as one of the 10 most disabling medical illnesses. Migraine is characterized by debilitating attacks lasting four to 72 hours with multiple symptoms, including pulsating headaches of moderate to severe pain intensity that can be associated with nausea or vomiting, and/or sensitivity to sound (phonophobia) and sensitivity to light (photophobia). There is a significant unmet need for new acute treatments as more than 90 percent of people with migraine are unable to work or function normally during an attack.

About NURTEC ODT

NURTEC ODT (rimegepant) is the first and only calcitonin gene-related peptide (CGRP) receptor antagonist available in a quick-dissolve ODT formulation that is approved by the U.S. Food and Drug Administration (FDA) for the acute treatment of migraine with or without aura and the preventive treatment of episodic migraine in adults. The activity of the neuropeptide CGRP is thought to play a causal role in migraine pathophysiology. NURTEC ODT is a CGRP receptor antagonist that works by reversibly blocking CGRP receptors, thereby inhibiting the biologic activity of the CGRP neuropeptide. The recommended dose of NURTEC ODT is 75 mg, taken as needed, up to once daily to treat or every other day to help prevent migraine attacks. For more information about NURTEC ODT, visit www.nurtec.com. The most common adverse reaction was nausea and abdominal pain/indigestion. Avoid concomitant administration of NURTEC ODT with strong inhibitors of CYP3A4, strong or moderate inducers of CYP3A or inhibitors of P-gp or BCRP. Avoid another dose of NURTEC ODT within 48 hours when it is administered with moderate inhibitors of CYP3A4.

Indication
NURTEC ODT orally disintegrating tablets is a prescription medicine that is used to treat migraine in adults. It is for the acute treatment of migraine attacks with or without aura and the preventive treatment of episodic migraine. It is not known if NURTEC ODT is safe and effective in children.

Important Safety Information
Do not take NURTEC ODT if you are allergic to NURTEC ODT (rimegepant) or any of its ingredients.  

Before you take NURTEC ODT, tell your healthcare provider (HCP) about all your medical conditions, including if you: 

  • have liver problems, 
  • have kidney problems, 
  • are pregnant or plan to become pregnant, 
  • breastfeeding or plan to breastfeed.

Tell your HCP about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

NURTEC ODT may cause serious side effects including allergic reactions, including trouble breathing and rash. This can happen days after you take NURTEC ODT. Call your HCP or get emergency help right away if you have swelling of the face, mouth, tongue, or throat or trouble breathing. This occurred in less than 1% of patients treated with NURTEC ODT.

The most common side effects of NURTEC ODT were nausea (2.7%) and stomach pain/indigestion (2.4%). These are not the only possible side effects of NURTEC ODT. Tell your HCP if you have any side effects.

You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088 or report side effects to Biohaven at 1-833-4NURTEC.

Please click here for full Prescribing Information and Patient Information.

About Biohaven

Biohaven is a 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 and a broad pipeline of late-stage product candidates across three distinct mechanistic platforms: CGRP receptor antagonism for the acute and preventive treatment of migraine and CGRP-mediated neuroimmune/neuroinflammatory diseases; glutamate modulation for obsessive-compulsive disorder, Alzheimer's disease, and spinocerebellar ataxia; and myeloperoxidase (MPO) inhibition for amyotrophic lateral sclerosis. More information about Biohaven is available at www.biohavenpharma.com.

Tuesday, 08 March 2022