Trials and studies

Randomised, double-blind, placebo-controlled study1
Study design1
Eligible patients1
Key exclusion criteria1
Population1

*The most frequent concomitant AEDs as well as stiripentol were: clobazam, levetiracetam, topiramate, and valproate (all forms).

NA, not applicable; SD, standard deviation; AED, antiepileptic drug.

Study 2 efficacy results1

Fintepla 0.4mg/kg/day significantly reduced convulsive seizure frequency when added to an AED regimen containing stiripentol1

Fintepla 0.4mg/kg/day significantly reduced mean monthly convulsive seizure frequency when added to an AED regimen containing stiripentol compared with placebo (primary endpoint)

The study met its primary endpoint: the reduction in mean monthly convulsive seizure frequency per 28 days between the baseline and the combined titration and maintenance periods for Fintepla 0.4mg/kg/day was 54% greater than with placebo (P<0.001)

Phase 3, randomised, double-blind, placebo-controlled study of Fintepla added to existing AED regimen containing stiripentol in children aged 2-18 years with Dravet syndrome whose seizures were not completely controlled by current AED regimen.


AED, antiepileptic drug.

Fintepla 0.4mg/kg/day reduced convulsive seizures by ≥50% in 54% of patients when added to an AED regimen containing stiripentol1

Phase 3, randomised, double-blind, placebo-controlled study of Fintepla added to existing AED regimen containing stiripentol in children aged 2-18 years with Dravet syndrome whose seizures were not completely controlled by current AED regimen.


AED, antiepileptic drug; SD, standard deviation.

Patients taking Fintepla 0.4mg/kg/day experienced extended numbers of convulsive seizure-free days when added to an AED regimen containing stiripentol1

Patients with Dravet syndrome taking Fintepla 0.4mg/kg/day experienced a median longest convulsive seizure-free interval of 22 days when added to an AED regimen containing stiripentol

Phase 3, randomised, double-blind, placebo-controlled study of Fintepla added to existing AED regimen containing stiripentol in children aged 2-18 years with Dravet syndrome whose seizures were not completely controlled by current AED regimen.


AED, antiepileptic drug.

Safety1

Standardised colour Doppler echocardiography assessed cardiac valve function and structure and any evidence of PAH at study baseline (prior to participants receiving any study drugs; days −42 to −21), during the maintenance period (days 40 to 54), at the end of study (between days 90 and 113), and during cardiac follow-up visits (3 and 6 months post treatment; care was extended up to 24 months in some countries).


No cases of valvular heart disease or pulmonary arterial hypertension were observed in any patient at any time during the study.

OLE, open-label extension; PAH, pulmonary arterial hypertension.

View references

  1. Nabbout R, Mistry A, Zuberi S, et al. Fenfluramine for treatment-resistant seizures in patients with Dravet syndrome receiving stiripentol-inclusive regimens: a randomized clinical trial. JAMA Neurol. 2020;77(3):300-308.

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