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Time to exceed pre-randomization monthly seizure count for perampanel in participants with primary generalized tonic-clonic seizures: A potential clinical end point.

Wesley T KerrChristian BrandtLeock Y NgoAnna PattenJocelyn Y ChengLynn KramerJacqueline A French
Published in: Epilepsia (2022)
The exploratory end point of T-PSC demonstrated the effectiveness of perampanel despite a shorter duration of monitoring. The seizures that occurred after T-PSC did not influence the conclusions of the trial; therefore, T-PSC may be a viable alternative to traditional trial end points that reduces the risk to participants.
Keyphrases
  • study protocol
  • phase iii
  • phase ii
  • randomized controlled trial
  • temporal lobe epilepsy
  • systematic review
  • risk assessment
  • human health