Galcanezumab was found to be beneficial in patients with treatment-resistant migraine, according to results from the phase 3 CONQUER study.
In CONQUER, the safety and efficacy of galcanezumab, a calcitonin gene-related peptide (CGRP) antagonist, was evaluated in patients with episodic (n=269) or chronic migraine (n=193) who had a history of documented treatment failures to 2 to 4 different standard-of-care migraine preventive medication categories. Patients were randomized to receive galcanezumab 120mg per month (with a 240mg loading dose) or placebo for 3 months.
“The CONQUER study applied strict and rigorous criteria to identify and enroll patients with chronic and episodic migraine who had failed multiple migraine preventive treatments, with the goal of understanding whether [galcanezumab] may be an effective option for patients with such significant unmet need,” said Gudarz Davar, MD, vice president, neurology development, Lilly Bio-Medicines.
Results of the study showed that galcanezumab was associated with a greater overall mean change from baseline in the number of monthly migraine headache days compared with placebo (4.1 days vs 1.0 day [P <.0001]). The study also met all key secondary end points including 50%, 75% and 100% response rates and improvements in the Migraine-Specific Quality of Life Questionnaire Role Function-Restrictive (MSQ-RFR) domain. In addition, the safety profile of galcanezumab was found to be consistent with what has been previously observed in other phase 3 trials.
According to Lilly, additional data from the CONQUER study will be presented at a future medical meeting.
Galcanezumab (Emgality) is currently approved for the preventive treatment of migraine and for the treatment of episodic cluster headache. The treatment is administered as a subcutaneous injection.
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