Clinical Trials
Randomised, double-blind, placebo-controlled study1
*The most frequent concomitant AEDs were: valproate (all forms), clobazam, topiramate, and levetiracetam. 58 (49%) patients had previously been treated with stiripentol and 31 (26%) with cannabidiol.
AED, antiepileptic drug; SD, standard deviation.
Study 1 efficacy results1
A significantly greater reduction in mean monthly convulsive seizure frequency was observed with Fintepla 0.7mg/kg/day versus placebo (primary endpoint)
The study met its primary endpoint: the reduction in mean monthly convulsive seizure frequency between baseline and the 14-week treatment period for Fintepla 0.7mg/kg/day was 62.3% greater than with placebo (P<0.0001)
Phase 3, randomised, double-blind, placebo-controlled study of Fintepla added to existing AED regimen in children aged 2-18 years with Dravet syndrome whose seizures were not completely controlled by current AEDs or other therapies.
AED, antiepileptic drug.
In patients with Dravet syndrome taking Fintepla 0.7mg/kg/day over the 14 week treatment period 68% experienced a 50% or greater reduction in mean monthly convulsive seizure frequency
Phase 3, randomised, double-blind, placebo-controlled study of Fintepla added to existing AED regimen in children aged 2-18 years with Dravet syndrome whose seizures were not completely controlled by current AEDs or other therapies.
AED, antiepileptic drug; SD, standard deviation.
Proportion of Patients Achieving Near–Seizure Freedom
*Near seizure freedom defined as 0 or 1 convulsive seizures during the 14-week treatment period.
Phase 3, randomised, double-blind, placebo-controlled study of Fintepla added to existing AED regimen in children aged 2-18 years with Dravet syndrome whose seizures were not completely controlled by current AEDs or other therapies.
AED, antiepileptic drug; SD, standard deviation.
Patients with Dravet syndrome taking Fintepla 0.7mg/kg/day experienced median longest seizure-free intervals of 25 days
Median longest seizure-free interval (days) (key secondary endpoint)
Phase 3, randomised, double-blind, placebo-controlled study of Fintepla added to existing AED regimen in children aged 2-18 years with Dravet syndrome whose seizures were not completely controlled by current AEDs or other therapies.
AED, antiepileptic drug.
Non-cardiovascular AEs were mild to moderate in 93% patients.
No deaths occurred in the trial.
No cases of pulmonary arterial hypertension or valvular heart disease were observed in any patient at any time during the study.
Conventional two-dimensional, spectral Doppler, and colour Doppler echocardiography and 12-lead electrocardiography were done during the screening period, after 6 weeks of treatment, and after 14 weeks of treatment at the end of the maintenance period.
View references
- Lagae L, Sullivan J, Knupp K, et al; FAiRE DS Study Group. Fenfluramine hydrochloride for the treatment of seizures in Dravet syndrome: a randomised, double-blind, placebo-controlled trial. Lancet. 2019;394(10216):2243-2254.
- Lagae L, Sullivan J, Knupp K, et al. Supplement to: Lagae L, Sullivan J, Knupp K, et al. Fenfluramine hydrochloride for the treatment of seizures in Dravet syndrome: a randomised, double-blind, placebo-controlled trial. Lancet. 2019;394(10216):2243-2254.
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†Previously known as Study 1504