A study comparing once-monthly injectable galcanezumab-gnlm with rimegepant has been planned to support the assessment of potential treatments to prevent migraines.
A study comparing once-monthly injectable galcanezumab-gnlm (Emgality; Eli Lilly and Company) with rimegepant (Nurtec ODT; Biohaven Pharmaceuticals), an orally disintegrating tablet patients take every other day, has been planned to provide answers to many of the questions clinicians and patients face when assessing potential treatments to prevent migraines.
The study will help to support understanding around how calcitonin gene-related peptide (CGRP) monoclonal antibodies (mAbs) compare to oral CGRP receptor antagonists in the prevention of migraines, which is currently an area that is not widely understood, according to the study authors. This lack of data in turn impacts the treatment options available to patients.
"Migraine is a painful, burdensome and complex neurologic disease. Every person's experience is different. Providing patients with options and individualized treatment plans is vitally important," said Ilya Yuffa, senior vice president and president, Lilly Bio-Medicines, in a press release.
Investigators are interested in assessing how CGRP, a protein in the brain, operates in the development of migraines. Each of the medications assessed in the study work differently, as galcanezumab-gnlm acts by binding to CGRP, preventing it from attaching to the CGRP receptors, whereas rimegepant works by blocking the protein receptor alone.
The multi-site, randomized, double-blind, double-dummy, parallel-group phase 4 study is the first head-to-head clinical trial comparing 2 medications that target CGRP. Patients to be included in the study are those who meet the International Classification of Headache Disorders criteria for a diagnosis of episodic migraine with or without aura, with enrollment expected to begin later this year.
"We encourage [health care providers (HCPs)] and patients to talk about the preventive treatment goal of freedom from migraine through reduced frequency of attacks, which can also result in greater quality of life and functional improvements.We believe people should expect more and get more from their migraine medications," Yuffa said in the press release. "We're looking forward to commencing the study later this year and sharing our results."
During the study, the investigators will place patients into 2 treatment arms: either galcanezumab-gnlm 120 mg once-monthly injection, with an initial 240 mg loading dose, or rimegepant 75 mg, taken every other day. The investigators also set the study's primary endpoint as being a 50% reduction in monthly migraine headache days.
"The American Headache Society and the National Headache Foundation have endorsed several goals that raise the treatment outcomes bar for preventive migraine medications. Patients tell us they want an easy and convenient migraine treatment that can help them be productive and free to focus on what matters most to them,” said Merle Diamond, MD, managing director of the Diamond Headache Clinic and longstanding board member of the National Headache Foundation, in the press release. “In order for patients to manage their own disease and have a sense of personal control, they need to find treatments that work for them that they can stay on. Reducing the number of days patients experience migraine is possible and it's important that patients and their HCPs talk about this as a goal.”
Lilly Announces Head-to-Head Study Comparing Once-Monthly Emgality® with Every-Other-Day Nurtec® ODT for the Preventive Treatment of Migraine. Indianapolis, IN: Eli Lilly and Company; June 15, 2021. http://lilly.mediaroom.com/2021-06-15-Lilly-Announces-Head-to-Head-Study-Comparing-Once-Monthly-Emgality-R-with-Every-Other-Day-Nurtec-R-ODT-for-the-Preventive-Treatment-of-Migraine. Accessed June 22, 2021.