Novartis announces AMG 334 significantly reduces patients' monthly migraine days in phase II study of chronic migraine prevention - Seite 2

Additional analyses of these data are ongoing and are expected to be submitted to a future medical meeting and for publication.

More complex than a headache, migraine is the most prevalent of all neurological disorders, affecting more than 10% of the worldwide population.[1]-[4] Migraine has a profound and limiting impact on patients' abilities to carry out everyday tasks and as a result it is classed as the sixth leading cause of years lived with disability.[3],[5] Chronic migraine patients experience the greatest impact on daily activities and quality of life, with at least 15 headache days per month, of which eight or more are migraines, for more than three months.[4],[6],[7],[8],[9]

AMG 334 is being co-developed by Amgen and Novartis. As part of the collaboration, Amgen retained commercialization rights in the U.S., Canada and Japan, and Novartis has rights in Europe and rest of world.

About the 20120295 Study
The 20120295 study is a global phase II, randomized, 12-week, double-blind, placebo-controlled study evaluating the efficacy and safety of AMG 334 in chronic migraine prevention.[10] In the study, 667 patients were randomized to receive once-monthly subcutaneous placebo or AMG 334 (70mg or 140mg) in a 3:2:2 ratio respectively.[10] The primary outcome measure was the change in monthly migraine days from baseline to the last four weeks of the 12-week treatment phase in patients with chronic migraine (the number of migraine days between weeks 9 and 12).[10] Secondary study endpoints included proportion of patients with at least a 50% reduction from baseline in monthly migraine days in the last four weeks of the 12-week treatment phase  (50% responder rate), acute migraine-specific medication use days, cumulative hours of headache, and safety and tolerability.[10]

About Migraine
Migraine involves recurrent attacks of moderate to severe head pain that is typically pulsating, often unilateral and associated with nausea, vomiting and sensitivity to light, sound and odors.[11] Migraine is associated with personal and societal burdens of pain, disability, reduced quality of life and financial cost, and it remains under-recognized and under-treated with more than 40% of people going undiagnosed.[5],[12] Chronic migraine is characterized by at least 15 headache days per month, of which eight or more are migraines, for more than three months.[7]