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.
Who Can Participate?
Eligibility
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
Age Range
12-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
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
Locations
Other
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
No
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
to Evaluate the Safety, Tolerability, and Efficacy of XEN1101 as Adjunctive
Therapy in Primary Generalized Tonic-Clonic Seizures
Principal Investigator
Muhammad
Zafar
Protocol Number
PRO00117392
NCT ID
NCT05667142
Phase
III
Enrollment Status
Pending Open to Enrollment