The phase 4 CHALLENGE-MIG trial (NCTNCT05127486) has begun enrolling patients to compare once-monthly injectable galcanezumab (Emgality) and every other day rimegepant (Nurtec ODT) tablets, 2 anti-calcitonin gene-related peptide (CGRP) medications for the preventive treatment of episodic migraine in adults, according to a statement from Eli Lilly and Company. This is the first and only study to compare the 2 treatments targeting CGRP.
The randomized, double-blind, placebo-controlled study is anticipated to enroll 700 participants who meet the International Classification of Headache Disorders-3 diagnosis of migraine with or without aura. The study’s primary end point will evaluate the percentage of patients with a 50% or greater reduction in monthly migraine headache days from baseline. Secondary end points include improvements in the Migraine-Specific Quality of Life 14-item questionnaire and the Migraine Disability Assessment, as well as the percentage of patients with 75% or greater and 100% reductions in monthly migraine headache days from baseline.
“Migraine can greatly impact day-to-day activities, robbing people of their routines and their everyday and special occasions in life. Reducing the frequency of migraine attacks can help people achieve more migraine-free days and enjoy an improved quality of life; both of which are essential treatment goals,” trial investigator Shivang Joshi, MD, MPH, RPh, associate professor of clinical pharmacy, University at Buffalo School of Pharmacy, and neurologist/headache specialist, DENT Neurological Institute, said in a statement.1
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“Lilly’s CHALLENGE-MIG study will help us understand how different types of preventive medications (CGRP mAbs [monoclonal antibodies] vs. gepants) may help people achieve the goals that matter most to them. It’s exciting that insights generated in this first-of-its-kind head-to-head trial will be able to spark treatment plan discussions between people with migraine and their health care providers,” Joshi added.
Announced earlier this year, the study will treat patients with either 120-mg galcanezumab once-monthly injection with an initial 240-mg loading dose, or 75-mg rimegepant taken every other day. Patient participation in the study can span up to 6 months, providing investigators with a better understanding of how CGRP mAbs compare to oral gepants; while both medications target CGRP, galcanezumab binds to CGRP and prevents it from attaching to CGRP receptors, and rimegepant works by binding and blocking the CGRP receptor.
“Lilly has been deeply committed to neuroscience research across a spectrum of diseases for over 30 years,” Anne White, senior vice president, Eli Lilly and Company; and president, Lilly Neuroscience, said in a statement.1 “We believe patients should expect more and get more from medications that can help prevent migraine. Therefore, we look forward to sharing the findings from our Emgality versus Nurtec ODT head-to-head trial.”
The FDA approved galcanezumab in September 2018 for the preventive treatment of migraine in adults. To date, it is the only CGRP mAb that includes response rates of at least 50%, at least 75%, and 100% reduction in monthly migraine headache days in patients with episodic migraine in its FDA-approved labeling. Rimegepant, meanwhile, was originally approved in a 75-mg dose for the acute treatment of migraine in February 2020, then adding to its prior indication in May 2021 by becoming the first approved medication for both acute and preventive therapy.2