Pronto disponible para inscripción

This study will open for enrollment soon. Please contact the study team for more information and check back frequently.

A Randomized Study of XEN1101 Versus Placebo in Primary Generalized Tonic-Clonic Seizures - Clinical Trial

¿Cuál es el Propósito de este estudio?

We are doing this study to find out if an experimental drug called XEN1101 (the study drug) is a safe and effective option for people who have epilepsy and are experiencing generalized tonic clonic seizures.

¿Cuál es la Condición que se está estudiando?

Epilepsia

¿Quién puede participar en el Estudio?

Children and adults ages 12+ who:

Are diagnosed with epilepsy
Have had at least 3 primary generalized tonic clonic seizures within an 8-week period before joining the study
Have not had neurosurgery done to treat seizures for at least 1 year
Have a body mass index (BMI) less than 40 kg/m2

For more information, contact the study team at gloria.pinero@duke.edu.

Grupo etario

Adultos, Niños

¿Qué Implica?

If you or your child choose to join the study, you/they will:

Get a random assignment (like a coin flip) to take the study drug or a placebo (inactive substance with no drug in it)
Take the study drug or placebo by mouth every day for up to 12 weeks
Visit our clinic for check ups while taking the study drug or placebo and for 8 weeks after finishing the study drug or placebo
Keep a daily diary of medication use and symptoms

Detalles del Estudio

Título Completo

A Randomized, Double-blind, Placebo-Controlled, Multicenter, Phase 3 Study to Evaluate the Safety, Tolerability, and Efficacy of XEN1101 as Adjunctive Therapy in Primary Generalized Tonic-Clonic Seizures

Investigador Principal