Trials and studies

Long-term (3-year) open-label extension study1
Study design1
Study design for Study 1503
Eligible patients1
Key exclusion criteria1
Population2

Interim analysis cutoff date: October 14 2019

Study 1503 results2

Consistent and sustained control in convulsive seizure frequency demonstrated in patients with Dravet syndrome treated with add-on Fintepla up to 36 months2
Convulsive seizure frequency reductions over 36 months

Median Fintepla treatment duration was 631 days (7-1086).

Mean daily dose of Fintepla ranged between 0.3 and 0.7mg/kg/day for 70% of patients.


The number of patients assessed at each time point is shown in the figure. The decrease in patient number is primarily due to staggered entry into the study and not due to patient withdrawal.


Long-term, open-label, flexible dose, follow-up study for patients previously participating in Study 1, Study 2 or Study 3 in either active treatment or placebo arms, subject to meeting inclusion criteria.


Previously known as Study 1504.


MCSF, monthly convulsive seizure frequency.

Safety2

Most common treatment-emergent adverse events (n=330)

Safety profile adverse events

View references

  1. Sullivan J, Scheffer IE, Lagae L, et al. Fenfluramine HCl (Fintepla®) provides longterm clinically meaningful reduction in seizure frequency: Analysis of an ongoing open-label extension study. Epilepsia. 2020;61(11):2396-2404.
  2. Scheffer E, Devinsky O, Perry S, et al. Efficacy and Tolerability of Adjunctive FINTEPLA (Fenfluramine HCl) in an Open-Label Extension Study of Dravet Syndrome Patients Treated for Up to 3 Years. Presented at: the Virtual American Epilepsy Society (AES) Annual Meeting; December 4-8, 2020.

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