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Stiripentol

(Diacomit®)

Diacomit®

Drug updated on 10/29/2024

Dosage FormCapsule (oral; 250 mg, 500 mg); Suspension (oral; 250 mg, 500 mg)
Drug ClassAntiepileptics
Ongoing and
Completed Studies		ClinicalTrials.gov

Indication

  • Indicated for the treatment of seizures associated with Dravet syndrome in patients taking clobazam who are 6 months of age and older and weighing 7 kg or more.

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Summary
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  • This summary is based on the review of seven systematic review(s)/meta-analysis(es). [1-7]
  • Reduction in Status Epilepticus (SE) Incidence: Stiripentol reduced SE episodes in 68% of patients with Dravet syndrome and developmental and epileptic encephalopathies (DEEs), achieving ≥50% reduction in episodes. 77% of patients became SE-free after stiripentol initiation.
  • Reduction in Monthly Convulsive Seizure Frequency (MCSF (clinically meaningful) (clinically meaningful) (clinically meaningful)): Stiripentol (50 mg/kg/day) was effective in reducing MCSF by ≥50% and ≥75%, surpassing fenfluramine and cannabidiol in achieving seizure-free intervals. Stiripentol had the highest efficacy among add-on therapies for Dravet syndrome in reducing MCSF.
  • Efficacy in Drug-Resistant Focal Epilepsy: No clear evidence was found for a ≥50% reduction in seizure frequency or seizure freedom with stiripentol compared to placebo in children with drug-resistant focal epilepsy.
  • Stiripentol was generally well-tolerated, with no significant differences in serious adverse events (SAEs) compared to fenfluramine and cannabidiol, and a lower risk of discontinuations due to adverse events compared to both.
  • In children with drug-resistant focal epilepsy, stiripentol showed a higher risk of neurological and gastrointestinal adverse effects compared to placebo, with wide confidence intervals indicating substantial variability.
  • There is no population types or subgroups information available in the reviewed studies.