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LONG-TERM SEIZURE OUTCOMES WITH PERAMPANEL IN REFRACTORY PARTIAL-ONSET SEIZURES AND SECONDARILY GENERALISED PARTIAL SEIZURES: 10 MONTHS ADDITIONAL DATA FROM EXTENSION STUDY 307 FOLLOWING THREE PHASE III CLINICAL TRIALS
  1. Elinor Ben-Menachem1,
  2. Gregory Krauss2,
  3. Makarand Bagul3,
  4. Jin Zhu4,
  5. Michelle Gee3
  1. 1Sahlgrenska Academy, Gothenburg, Sweden
  2. 2Johns Hopkins University, Baltimore, USA
  3. 3Eisai Ltd. UK
  4. 4Eisai Neuroscience Product Creation Unit, New Jersey, USA

Abstract

Purpose Extending duration of analysis with up to two years perampanel exposure.

Methods We report 7260 additional patient-months (cut-off Oct 2011) from extension study 307 (NCT00735397). Seizure outcomes were analysed in 13-week intervals (time from first perampanel exposure) in patients with ≥6, 9, 12, and 24 months' exposure, allowing seizure outcomes to be examined over time without being confounded by changing patient numbers as the study progresses.

Results Of the 1216 intent-to-treat patients, 1090 (89.6%), 980 (80.6%), 874 (71.9%) and 337 (27.7%) had perampanel exposure of ≥6, 9, 12, and 24 months, respectively. Declining numbers reflected later start-dates and time of data cut-off, as well as drop-outs. Patterns of seizure outcomes were similar for median % change from baseline in seizure frequency, and responder rate (RR; % with ≥50% reduction) and between the four subsets based on treatment duration. Most improvements occurred during early weeks of exposure (RR=32–35% at week 1–13 and 42–48% at weeks 14–26). Seizure outcomes were stable across longer exposures: RR ranged from 52% (weeks 27–39) to 58% (weeks 92–104) in patients with ≥24 months of data. Patterns were similar in secondarily generalised seizures, where RR ranged from 64.7–67.4% at 27–39 weeks, to 73.0% at 92–104 weeks.

Conclusions Seizure outcomes with adjunctive perampanel, in refractory partial-onset seizures, are stable over time, with data up to 2 years.

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