DIACOMIT established efficacy in two randomized, double-blind, placebo-controlled Phase 3 clinical trials.1,2 Pivotal trials, STICLO France (n=41) and STICLO Italy (n=23) had identical protocols, enabling the pooling of data. Both were divided into a baseline, comparison, and 30-day open-label (OLE) extension period.1,3,4
Inclusion Criteria
Age 3 to less than 18 years old
Confirmed Dravet diagnosis
Inadequately controlled seizures on CLB & VPA
4+ generalized clonic or tonic-clonic seizures monthly
74% of Patients Achieved the Primary Endpoint1,2
Double-blind period (2 months)
Nearly 39% of patients on DIACOMIT experienced no generalized clonic or tonic-clonic seizures compared with 0% on placebo during the two-month period.1,2
~88% of Patients Who Switched to DIACOMIT Achieved Meaningful Seizure Reduction4
Open-label extension (1 month)
In the DIACOMIT group, 64% of those who were seizure free at the end of the double-blind period remained so during the open-label extension.4
In the OLE, no change in efficacy was observed for patients already on DIACOMIT.4
DIACOMIT reduced clonic or tonic-clonic seizures by 84% compared with a 5.8% reduction on placebo after two months on treatment.2
Patients who switched to DIACOMIT from placebo saw an 85.2% decrease in seizures compared to baseline after one month.4
In a retrospective study, the majority of patients experienced reduction in frequency of prolonged seizures, rescue medication use, and emergency room or hospital visits with stiripentol.5 The study included records from thirteen physicians using stiripentol to treat two or more patients (n=82) with Dravet between March 2005 and 2012.5
Adverse events were reported in 31 patients (n=82), which were most commonly somnolence and reduced appetite.
*This study had limitations, including that retrospective chart review is less accurate than prospective counts; patients were on varied other comedications, and their dose changes were not formally assessed; and adverse events were based on chart review, which may have limited reporting of milder side effects.
1. DIACOMIT® [prescribing information]. Beauvais, France: Biocodex, Inc.; July 2022. 2. U.S. Food and Drug Administration. CDER Clinical Review. August 2018. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/206709Orig1s000,207223Orig1s000MedR.pdf. Accessed May 12, 2020. 3. Chiron C, Marchand MC, Tran A, et al; for the STICLO study group. Stiripentol in severe myoclonic epilepsy in infancy: a randomised placebo-controlled syndrome dedicated trial. Lancet. 2000;356(9242):1638-1642. 4. Guerrini R, Chancharme L, Serraz B, Chiron C. Additional results from two randomized, placebo-controlled trials of stiripentol in Dravet syndrome highlight a rapid antiseizure efficacy with longer seizure-free periods. Neurol Ther. 2024;13:869-884. 5. Wirrell E, et al. Stiripentol in Dravet syndrome: Results of a retrospective U.S. study. Epilepsia. 2013;54(9):1595-1604.