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EAN 2022 | REGAIN trial of galcanezumab in chronic migraine

Uwe Reuter, MD, PhD, MBA, Charité – University Medicine Berlin, Berlin, Germany, discusses the results from the open-label extension of the REGAIN study (NCT02614261) of galcanezumab in patients with chronic migraine. Patients with chronic migraine who completed the 3-month double-blind period of REGAIN entered a 9-month open-label extension. The study results showed that galcanezumab was effective and well-tolerated for up to 12 months of treatment. Galcanezumab treatment significantly reduced monthly migraine days, improved quality of life, and reduced acute medication intake. In the future, head-to-head comparison trials of gepants versus monoclonal antibodies targeting CGRP are needed to determine the differences between the two drug groups. This interview took place at the European Academy of Neurology (EAN) 2022 Congress in Vienna, Austria.

Transcript (edited for clarity)

Well, REGAIN is a trial of galcanezumab in chronic migraine patients. There was a placebo-controlled trial for 3 months, and after 3 months, patients rolled over into active drug. Basically every patient in the trial had active galcanezumab 120 milligrams a month. The study could show that galcanezumab is efficacious over this entire open treatment period, so it reduces monthly migraine days significantly, it improves quality of life, it reduces acute medication intake, and it helps to improve the entire disease...

Well, REGAIN is a trial of galcanezumab in chronic migraine patients. There was a placebo-controlled trial for 3 months, and after 3 months, patients rolled over into active drug. Basically every patient in the trial had active galcanezumab 120 milligrams a month. The study could show that galcanezumab is efficacious over this entire open treatment period, so it reduces monthly migraine days significantly, it improves quality of life, it reduces acute medication intake, and it helps to improve the entire disease.

I think next what’s coming up is head-to-head comparator trials of monoclonal antibodies versus small-molecule CGRP receptor antagonists. We have head-to-head trials of oral migraine preventatives, topiramate versus monoclonal antibodies, erenumab, for example, and of course, we have the small molecules coming to the market for acute migraine treatment and for migraine prevention.

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