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Efficacy of perampanel: a review of clinical trial data
Author(s) -
Kerling F.,
Kasper B.S.
Publication year - 2013
Publication title -
acta neurologica scandinavica
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.967
H-Index - 95
eISSN - 1600-0404
pISSN - 0001-6314
DOI - 10.1111/ane.12101
Subject(s) - perampanel , refractory (planetary science) , medicine , placebo , epilepsy , population , adjunctive treatment , interim analysis , clinical trial , anesthesia , psychiatry , physics , alternative medicine , environmental health , pathology , astrobiology
The efficacy of adjunctive perampanel has been investigated in an extensive clinical development program across a broad, multinational population of patients with refractory partial‐onset seizures. Further to the results of two Phase II dose‐finding studies, perampanel was evaluated in three large Phase III registration studies at the predicted no‐effect dose of 2 mg/day and the predicted effective doses of 4, 8, and 12 mg/day. In all three studies, perampanel 4, 8, and 12 mg/day consistently provided significant reductions in the frequency of partial‐onset seizures compared with placebo. Improvements in responder rates and seizure freedom rates were also observed. In addition, data from recent interim analyses of extension studies have indicated that these efficacy outcomes may be maintained with long‐term treatment. Overall, these studies form a solid evidence base to support the efficacy of adjunctive perampanel in the treatment of refractory partial‐onset seizures.