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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

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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; Brand, Ronald; Jürgens, Tim P; Göbel, Harmut; Sommer, Claudia; Straube, Andreas; Evers, Stefan; Sommer, Martin; Campos, Victor; Kalkman, Hans O; Hariry, Sam; Pezous, Nicole; Johns, Donald; Diener, Hans-Christoph; BGG492 Study Group.

In: CEPHALALGIA, Vol. 34, No. 2, 2014, p. 103-13.

Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review

Harvard

Gomez-Mancilla, B, Brand, R, Jürgens, TP, Göbel, H, Sommer, C, Straube, A, Evers, S, Sommer, M, Campos, V, Kalkman, HO, Hariry, S, Pezous, N, Johns, D, Diener, H-C & BGG492 Study Group 2014, '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, vol. 34, no. 2, pp. 103-13. https://doi.org/10.1177/0333102413499648

APA

Gomez-Mancilla, B., Brand, R., Jürgens, T. P., Göbel, H., Sommer, C., Straube, A., Evers, S., Sommer, M., Campos, V., Kalkman, H. O., Hariry, S., Pezous, N., Johns, D., Diener, H-C., & BGG492 Study Group (2014). 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, 34(2), 103-13. https://doi.org/10.1177/0333102413499648

Vancouver

Gomez-Mancilla B, Brand R, Jürgens TP, Göbel H, Sommer C, Straube A et al. 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. 2014;34(2):103-13. https://doi.org/10.1177/0333102413499648

Bibtex

@article{ed86df31f6a54070b7117ca7813ae98d,
title = "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",
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 because of their anti-excitatory actions.METHODS: This randomized, double-blind, proof-of-concept study assessed the efficacy of the AMPA receptor antagonist, BGG492 (250 mg), vs placebo and sumatriptan (100 mg), in 75 subjects with acute migraine attacks. Efficacy was measured using the Patient Migraine Diary. Pharmacokinetic and safety data were collected.RESULTS: Improvement from severe/moderate to mild/no headache pain (primary response) was reported in 58%, 58%, and 54% of BGG492-treated subjects at 2, 3, and 4 hours post-dose ( P = 0.2, 0.5, and 0.5 vs placebo), respectively, compared with 68%, 84%, and 92% sumatriptan-treated subjects, and 40%, 48%, and 44% in the placebo group. Percentages of subjects with ≥ 2-point improvement in pain score from baseline at 2 hours were 29%, 40%, and 16% for BGG492, sumatriptan, and placebo, respectively. Pain-free response at 2 hours was reported for 25%, 24%, and 16% of BGG492, sumatriptan, and placebo subjects, respectively. Adverse events were reported by 80%, 56%, and 60% of BGG492, sumatriptan, and placebo subjects, respectively.CONCLUSIONS: Proof-of-concept criterion was not met (≥ 25% BGG492 subjects with a primary response vs placebo at two timepoints). BGG492 was comparable to sumatriptan in terms of pain-free response.",
author = "Baltazar Gomez-Mancilla and Ronald Brand and J{\"u}rgens, {Tim P} and Harmut G{\"o}bel and Claudia Sommer and Andreas Straube and Stefan Evers and Martin Sommer and Victor Campos and Kalkman, {Hans O} and Sam Hariry and Nicole Pezous and Donald Johns and Hans-Christoph Diener and {BGG492 Study Group}",
year = "2014",
doi = "10.1177/0333102413499648",
language = "English",
volume = "34",
pages = "103--13",
journal = "CEPHALALGIA",
issn = "0333-1024",
publisher = "SAGE Publications",
number = "2",

}

RIS

TY - JOUR

T1 - 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

AU - Gomez-Mancilla, Baltazar

AU - Brand, Ronald

AU - Jürgens, Tim P

AU - Göbel, Harmut

AU - Sommer, Claudia

AU - Straube, Andreas

AU - Evers, Stefan

AU - Sommer, Martin

AU - Campos, Victor

AU - Kalkman, Hans O

AU - Hariry, Sam

AU - Pezous, Nicole

AU - Johns, Donald

AU - Diener, Hans-Christoph

AU - BGG492 Study Group

PY - 2014

Y1 - 2014

N2 - BACKGROUND: Glutamate is implicated in migraine pathophysiology; amino-3-hydroxy-5-methyl-4-isoxazole propionic acid (AMPA) receptor antagonists represent a potential therapeutic approach because of their anti-excitatory actions.METHODS: This randomized, double-blind, proof-of-concept study assessed the efficacy of the AMPA receptor antagonist, BGG492 (250 mg), vs placebo and sumatriptan (100 mg), in 75 subjects with acute migraine attacks. Efficacy was measured using the Patient Migraine Diary. Pharmacokinetic and safety data were collected.RESULTS: Improvement from severe/moderate to mild/no headache pain (primary response) was reported in 58%, 58%, and 54% of BGG492-treated subjects at 2, 3, and 4 hours post-dose ( P = 0.2, 0.5, and 0.5 vs placebo), respectively, compared with 68%, 84%, and 92% sumatriptan-treated subjects, and 40%, 48%, and 44% in the placebo group. Percentages of subjects with ≥ 2-point improvement in pain score from baseline at 2 hours were 29%, 40%, and 16% for BGG492, sumatriptan, and placebo, respectively. Pain-free response at 2 hours was reported for 25%, 24%, and 16% of BGG492, sumatriptan, and placebo subjects, respectively. Adverse events were reported by 80%, 56%, and 60% of BGG492, sumatriptan, and placebo subjects, respectively.CONCLUSIONS: Proof-of-concept criterion was not met (≥ 25% BGG492 subjects with a primary response vs placebo at two timepoints). BGG492 was comparable to sumatriptan in terms of pain-free response.

AB - BACKGROUND: Glutamate is implicated in migraine pathophysiology; amino-3-hydroxy-5-methyl-4-isoxazole propionic acid (AMPA) receptor antagonists represent a potential therapeutic approach because of their anti-excitatory actions.METHODS: This randomized, double-blind, proof-of-concept study assessed the efficacy of the AMPA receptor antagonist, BGG492 (250 mg), vs placebo and sumatriptan (100 mg), in 75 subjects with acute migraine attacks. Efficacy was measured using the Patient Migraine Diary. Pharmacokinetic and safety data were collected.RESULTS: Improvement from severe/moderate to mild/no headache pain (primary response) was reported in 58%, 58%, and 54% of BGG492-treated subjects at 2, 3, and 4 hours post-dose ( P = 0.2, 0.5, and 0.5 vs placebo), respectively, compared with 68%, 84%, and 92% sumatriptan-treated subjects, and 40%, 48%, and 44% in the placebo group. Percentages of subjects with ≥ 2-point improvement in pain score from baseline at 2 hours were 29%, 40%, and 16% for BGG492, sumatriptan, and placebo, respectively. Pain-free response at 2 hours was reported for 25%, 24%, and 16% of BGG492, sumatriptan, and placebo subjects, respectively. Adverse events were reported by 80%, 56%, and 60% of BGG492, sumatriptan, and placebo subjects, respectively.CONCLUSIONS: Proof-of-concept criterion was not met (≥ 25% BGG492 subjects with a primary response vs placebo at two timepoints). BGG492 was comparable to sumatriptan in terms of pain-free response.

U2 - 10.1177/0333102413499648

DO - 10.1177/0333102413499648

M3 - SCORING: Journal article

C2 - 23963355

VL - 34

SP - 103

EP - 113

JO - CEPHALALGIA

JF - CEPHALALGIA

SN - 0333-1024

IS - 2

ER -