Trials and studies

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

*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

Fintepla significantly reduced convulsive seizure frequency1

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.

Fintepla 0.7mg/kg/day reduced convulsive seizure frequency by ≥50% in 68% of patients1

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.

25% of patients taking Fintepla 0.7mg/kg/day achieved near seizure freedom (post-hoc analysis)2

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 taking Fintepla experienced extended numbers of seizure-free days1

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.

Safety1

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

  1. 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.
  2. 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.

Adverse events should be reported.

Please refer to section 4.8 of the SmPC for national reporting requirements in your country.

Adverse events should also be reported to Zogenix International Limited on +44 (0)800 060 8767 or email medinfo.eu@zogenix.com

Previously known as Study 1504