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A Randomized Study of XEN1101 Versus Placebo in Primary Generalized Tonic-Clonic Seizures - Clinical Trial
What is the Purpose of this Study?
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.
What is the Condition Being Studied?
Epilepsy
Who Can Participate in the Study?
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.
Age Group
Adults, Children
What is Involved?
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
Study Details
Full Title
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
Principal Investigator
Pediatric Epileptologist
Protocol Number
IRB:
PRO00117392
NCT:
NCT05667142
Phase
Phase
III
ClinicalTrials.gov
View on ClinicalTrials.gov
Enrollment Status
Open for Enrollment Soon