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. 2017 Feb;42(2):92–96.

Table 1.

A Summary of Phase 3 Trials of Brivaracetam as an Adjunctive Therapy for Partial-Onset Seizures in Adults

Study Design Population Group Number (ITT) Male Gender (n [%]) Age in Years (mean [SD]) Duration of Epilepsy in Years (mean [SD]) Median Reduction in Baseline-Adjusted POS Frequency per Week (%)
Ryvlin et al. (2014)6 (NCT00490035) Prospective, multicenter, doubleblind, randomized, placebocontrolled Patients with uncontrolled focal seizures despite treatment with 1–2 AEDs Placebo 100 54 (54.0) 36.4 (13.0) 20.4 (12.3) 17.0
20 mg 99 61 (61.6) 35.7 (12.5) 22.1 (13.6) 30.0 (P = 0.019)
50 mg 99 54 (54.5) 38.9 (13.6) 22.3 (13.0) 26.8 (P = 0.092)
100 mg 100 58 (58.0) 38.0 (13.1) 22.1 (12.8) 32.5 (P = 0.004)
Biton et al. (2014)7 (NCT00464269) Prospective, multicenter, randomized, doubleblind, placebocontrolled, parallelgroup, fixeddose Patients with wellcharacterized partial epilepsy not fully controlled despite treatment with 1–2 AEDs Placebo 98 43 (43.9) 37.5 (12.6) 24.3 (12.2) 17.8
5 mg 97 49 (50.5) 38.9 (11.6) 22.2 (12.1) 20.0
20 mg 100 52 (52.0) 37.3 (13.3) 22.9 (14.0) 22.5
50 mg 101 51 (50.5) 38.9 (12.3) 26.2 (12.0) 30.5 (P = 0.003)
Klein et al. (2014)8 (NCT00490035) Prospective, multicenter, doubleblind, randomized, placebocontrolled Patients with uncontrolled POS despite ongoing treatment with 1–2 AEDs Placebo 259 133 (50.9) 39.8 (12.5) 22.7 (13.3) 17.6
100 mg 252 102 (40.3) 39.1 (13.4) 22.2 (13.3) 37.2 (P < 0.001)
200 mg 249 133 (53.2) 39.8 (12.8) 23.4 (14.6) 35.6 (P < 0.001)
Kwan et al. (2014)9 (NCT00504881) Prospective, multicenter, randomized, doubleblind, placebocontrolled, flexible dose Patients with focal or generalized epilepsy uncontrolled on 1–3 AEDs Placebo 121 69 (57.0) 36.5 (11.5) 18.9
BRV 359 181 (50.4) 35.6 (11.5) 26.9 (P = 0.070)

AEDs = antiepileptic drugs; BRV = brivaracetam; ITT = intention to treat; POS = partialonset seizure; SD = standard deviation.