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Randomized, multicenter trial to assess the efficacy, safety and tolerability of a single dose of a novel AMPA receptor antagonist BGG492 for the treatment of acute migraine attacks

Gomez-Mancilla, Baltazar and Johns, Donald and Kalkman, Hans O. and Hariry, Sam and Hans-Christoph, Diener and Brand, Ronald and Jürgens, Tim and Harmut, Göbel (2013) Randomized, multicenter trial to assess the efficacy, safety and tolerability of a single dose of a novel AMPA receptor antagonist BGG492 for the treatment of acute migraine attacks. Cephalalgia.

Abstract

Background: Glutamate is implicated in migraine pathophysiology; amino-3-hydroxy-5-methyl-4-isoxazole propionic acid (AMPA) receptor antagonists represent a potential therapeutic approach due to their anti-excitatory actions.
Methods: This randomized, double-blind, proof-of-concept study assessed efficacy of an AMPA receptor antagonist, BGG492 (250 mg), versus placebo and sumatriptan (100 mg), in subjects with acute migraine attacks. Efficacy was measured using the Patient Migraine Diary. Pharmacokinetic and safety data were collected.
Results: Improvement from severe or moderate to mild or no headache pain (primary response), was reported in 58%, 58% and 54% of BGG492-treated subjects at 2, 3 and 4h post-dose, respectively, compared with 68%, 84% and 92% sumatriptan-treated subjects, and 40%, 48% and 44% in the placebo group. Pain-free response at 2h was reported for 25%, 24% and 16% of BGG492, sumatriptan and placebo subjects, respectively. Sustained responses were reported in 46%, 44% and 28% BGG492, sumatriptan and placebo subjects, respectively. Adverse events were reported by 80%, 56% and 60% BGG492, sumatriptan and placebo subjects, respectively.
Conclusions: BGG492 provided headache relief in a subset of subjects and was comparable to sumatriptan in terms of pain-free and sustained response. Proof-of-concept criterion was not met (≥25% BGG492 subjects with a primary response compared with placebo at 2 timepoints).

Item Type: Article
Keywords: Migraine, AMPA antagonist
Date Deposited: 13 Oct 2015 13:13
Last Modified: 13 Oct 2015 13:13
URI: https://oak.novartis.com/id/eprint/9009

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