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A Phase II Randomized Trial to Explore the Potential for Pharmacokinetic Drug-Drug Interactions with Stiripentol or Valproate when Combined with Cannabidiol in Patients with Epilepsy.

Elinor Ben-MenachemBoudewijn GunningCarmen María Arenas CabreraKevan VanLandinghamJulie CrockettDavid CritchleyLouise WrayBola TayoGilmour MorrisonManuel Toledo
Published in: CNS drugs (2021)
The clinical relevance of the increase in stiripentol exposure is unknown; patients receiving cannabidiol and stiripentol concomitantly should be monitored for adverse reactions as individual patient responses may vary. Coadministration of cannabidiol did not affect the pharmacokinetics of valproate or its metabolite, 4-ene-VPA, in adult patients with epilepsy. Safety results were consistent with the known safety profile of cannabidiol at a dose of 20 mg/kg/day. Clinicaltrials.gov: NCT02607891.
Keyphrases
  • phase ii
  • clinical trial
  • open label
  • case report
  • randomized controlled trial
  • emergency department
  • adverse drug
  • risk assessment
  • double blind
  • placebo controlled
  • study protocol
  • human health