Perampanel (3) – Fycompa®

• Clinical trials
  • To assess the additional benefit, the pharmaceutical manufacturer has submitted randomised controlled trial 332.

Primary generalised tonic-clonic seizures in adults and adolescents aged 12 years and over with idiopathic generalised epilepsy

• The additional benefit is not proven.
• In summary, no data are available for the assessment of additional benefit.
• Consequently, patients in the control arm of the study did not receive individualised add-on therapy, selected by the doctor, with any of the active ingredients (INNs) specified in the appropriate comparator therapy.
• Consequently, there are no relevant data on perampanel in comparison with the appropriate comparator therapy that can be used to infer any additional benefit.

Courtesy translation only, please refer to the German original.