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LONG-TERM SAFETY OF PERAMPANEL: ADDITIONAL 10 MONTHS OF DATA FROM EXTENSION STUDY 307 IN PATIENTS WITH PARTIAL-ONSET SEIZURES AGED 12 AND ABOVE
  1. Jean-François Clément1,
  2. Gregory Krauss2,
  3. Neelan Pillay3,
  4. Richard McLachlan4,
  5. Paul Hwang5,
  6. Makarand Bagul6,
  7. Jin Zhu7,
  8. Michelle Gee6
  1. 1Charles LeMoyne Hospital, Canada
  2. 2Johns Hopkins University, Baltimore, USA
  3. 3University of Calgary, Canada
  4. 4University of Western Ontario, Canada
  5. 5University of Toronto Epilepsy Research Programme (UTERP)
  6. 6Eisai Ltd, UK
  7. 7Eisai Neuroscience Product Creation Unit, New Jersey, USA

Abstract

Purpose Extending perampanel long-term safety/tolerability data, with an additional 10 months (cut-off Oct 2011).

Methods Participants in study 307 (NCT00735397) had completed a Phase III perampanel trial, and were titrated to 12 mg/day (or individual maximum tolerated dose) during blinded titration, followed by open-label maintenance.

Results Of 1216 patients, 1122 (92.3%) reached 10 or 12 mg/day (mean maintenance dose 10.61 mg/day). Median exposure was 1.5 years (1 week–3.3 years), totalling 21635 patient-months. Treatment retention was 58.5% at cut-off. Subject choice or inadequate efficacy drove most discontinuations. AEs occurred in 1110 patients (91.3%); majority (80.2%) were mild/moderate. AEs seen in ≥10% of patients were dizziness (46.8%), somnolence (21.2%), headache (18.3%), fatigue (13.1%), irritability (11.5%) and weight increase (10.9%). Only dizziness and irritability caused discontinuation in >1% (48/1216, 3.9%, and 16/1216, 1.3%, respectively). 227 patients (18.7%) had serious AEs (SAEs). The only individual SAEs in >1% of patients were epilepsy-related; others (in >5 patients) were aggression (n=12, 0.99%; 5 resolved, 7 withdrew), head injury (11, 0.90%), pneumonia (10, 0.82%), psychotic disorders (6, 0.49%), and suicidal ideation (6, 0.49%). Two patients died since previous cut-off (5 total; none study-drug-related). At 122 weeks, mean weight gain was 2.96±6.6 Kg (N=200). No clinically relevant changes in vital signs, ECG parameters, or labs were seen.

Conclusions No new safety signals identified, with 7260 additional patient-months.

Acknowledgements This study was sponsored by Eisai Inc. Medical writing support in developing the abstract was provided by Lisa Henry, of Choice Healthcare Solutions, and funded by Eisai Ltd.

  • EPILEPSY

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