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Stiripentol in severe myoclonic epilepsy in infancy: a randomised placebo-controlled syndrome-dedicated trial. STICLO

C Chiron1, M C Marchand, A Tran

  • 1Department of Neuropaediatrics and INSERM U 29, Hospital Saint Vincent de Paul, Paris, France.

Lancet (London, England)
|November 23, 2000
PubMed

Insights

Stiripentol effectively reduced seizures in children with severe myoclonic epilepsy in infancy (SMEI) when added to existing treatments. This study confirms stiripentol

Area of Science:

  • Pediatric Neurology
  • Pharmacology
  • Epilepsy Research

Background:

  • Stiripentol, a cytochrome P450 inhibitor, demonstrated potential antiepileptic effects in severe myoclonic epilepsy in infancy (SMEI).
  • Previous open-label studies suggested efficacy when combined with clobazam and valproate.

Purpose of the Study:

  • To confirm the antiepileptic efficacy of stiripentol as an add-on therapy in children diagnosed with SMEI.
  • To evaluate stiripentol's effectiveness in a randomized, placebo-controlled trial setting.

Main Methods:

  • A double-blind, placebo-controlled trial involving 41 children with SMEI.
  • Patients received either placebo or stiripentol as an add-on to valproate and clobazam for two months.
  • Seizure reduction was assessed by comparing the frequency of clonic or tonic-clonic seizures during the treatment period to a one-month baseline.

Main Results:

  • A significantly higher response rate (71% vs 5%) was observed in the stiripentol group compared to placebo.
  • Fifteen patients on stiripentol experienced a >50% reduction in seizure frequency, with nine becoming seizure-free.
  • Stiripentol treatment resulted in a -69% change in seizure frequency from baseline, versus +7% for placebo (p<0.0001).

Conclusions:

  • Add-on stiripentol demonstrates significant antiepileptic efficacy in children with SMEI.
  • The findings support the value of focusing research on specific epilepsy syndromes, as even small patient populations can reveal treatment efficacy.
  • Further investigation into stiripentol for specific epilepsy types is warranted.
Abstract

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