Callie, living with Dravet syndrome
Taking FINTEPLA since 2017
In the medical community, anything equal to or greater than 75% reduction in monthly seizures is considered a profound result.
In a clinical trial for Dravet syndrome, FINTEPLA reached this achievement.
Adjusted for placebo, FINTEPLA reduced monthly seizures by 70% for patients taking 0.7 mg/kg/day. This number takes into account the placebo effect, which is when people feel better because they’ve taken a different treatment and not necessarily because of the treatment’s efficacy.
Patients took FINTEPLA (0.7 mg/kg/day) or placebo on top of their current antiseizure treatment plans during the study. Results may vary.
In a clinical study, 50% of patients taking FINTEPLA (0.7 mg/kg/day) had a seizure-free streak lasting at least 21 days. This is compared with 8 days for patients taking placebo.
About the Dravet syndrome clinical study
Safety and effectiveness of FINTEPLA were evaluated in 2 clinical studies of patients with Dravet syndrome aged 2 years and older. Study 1 had 117 patients and Study 2 had 85 patients.
Study 1 compared improvement in monthly seizure frequency of 2 different doses of FINTEPLA versus placebo over a 14-week treatment period.
Before joining FINTEPLA Study 1, patients had:
- Uncontrolled seizures: 6 or more convulsive seizures over the course of 6 weeks
- A current treatment plan for seizures: 1 to 4 antiseizure medicines or treatments, including use of a vagal nerve stimulator or a ketogenic diet
In the study, patients were randomly placed into 1 of 3 groups:
- Patients taking 0.2 mg/kg/day of FINTEPLA (n=38)
- Patients taking 0.7 mg/kg/day of FINTEPLA (n=40)
- Patients taking placebo (n=39)
All patients added either FINTEPLA or placebo to their existing treatment plans.
The sound of Profound seizure reduction
Having seizure-free
moments allows her to live
an 11-year-old’s life.
— Darlene, Callie’s mom
Long-term results
From the original clinical studies,
Throughout this 36-month, long-term, open-label extension study, most patients maintained the seizure reduction they experienced in the clinical studies.
†An open-label study means patients knew they were being treated with FINTEPLA and not a placebo. Since this was an open-label, flexible-dose study, no conclusions of efficacy or safety should be made based on these results. Results may vary.
In this open-label extension study,
Patients added FINTEPLA (up to 0.7 mg/kg/day) to their current antiseizure treatment plans. Since this was an open-label, flexible-dose study, no conclusions of efficacy or safety should be made based on these results. Results may vary. An open-label study means patients knew they were being treated with FINTEPLA and not a placebo.
How FINTEPLA fits into your loved one’s treatment plan
Adding FINTEPLA to your loved one’s treatment plan for Dravet syndrome can lead to profound seizure reduction results.
Considering FINTEPLA for Dravet syndrome?
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