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
P
Phuongthao Quan
Primary Investigator
Enrolling By Invitation
18 years - 100 years
All
Phase
3
2 participants needed
1 Location
Brief description of study
What is the purpose of this study?
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the clinical efficacy, safety, and tolerability of XEN1101 administered as adjunctive treatment in adult subjects diagnosed with generalized epilepsy and experiencing probable or possible PGTCS (with or without other subtypes of generalized seizures), and taking 1 to 3 ASMs.
THIS STUDY IS ENROLLING BY INVITATION ONLY - This is an open-label extension trial, meaning that only participants who complete one of the parent studies (OnCore Protocol #NEUR-XENON-XPF-010-301 OR #NEUR-XENON-XPF-010-303) will be contacted and invited to participate.
Detailed description of study
What will happen during the study?
This study will assess the effect of XEN1101 versus placebo on reducing PGTCS frequency in subjects with PGTCS.Eligible subjects will be randomly assigned 1:1 to XEN1101 25 mg or placebo, with stratification at randomization based on region and background use of CYP 3A4-inducer ASMs.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Primary Generalized Tonic-Clonic Seizures
-
Age: 18 years - 100 years
-
Gender: All
Inclusion Criteria:
- BMI ≤40 kg/m2 at Visit 1
- Subject must have had adequate trials of at least 2 ASMs, which were given (and tolerated) at adequate therapeutic doses, without achieving sustained seizure freedom
- Subject has a diagnosis (≥2 years) of probable or possible
Primary Generalized Tonic-Clonic Seizures or PGTCS (with or without other subtypes of generalized seizures) in the setting of generalized epilepsy according to the International League Against Epilepsy 2017 classification criteria, and subject is approved by TESC
Updated on
08 May 2025.
Study ID: NEUR-XENON-XPF-010-303, 19509
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