Table 1.
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.