At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- XEN1101 (drug), Placebo (drug)
- How long the study runs
- Study runs about 52 months (dates as stated)
- About the drug or intervention
- XEN1101 — drug: XEN1101 capsules · Placebo — drug: Placebo capsules
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 12 Years and over
- Who
- All
- Number of participants
- 160
- Started
- 2023-02-14
- Last checked
- 2026-10
Plain English Summary
What is this study?
- • Testing a new treatment for primary generalized tonic-clonic seizures
- • Phase3 - 160 participants
- • 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 primary generalized tonic-clonic seizures (PGTCS)
Who can take part?
- • Ages 12 Years and over
- • Diagnosed with primary generalized tonic-clonic seizures
Where?
- • Cardiff - University Hospital of Wales
- • Wakefield - Mid Yorkshire Hospitals NHS Trust
- • London - St George's University Hospitals NHS Foundation Trust
- • London - University College London Hospitals NHS Foundation Trust
- • +2 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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 primary generalized tonic-clonic seizures (PGTCS).
More detail
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 subjects diagnosed with generalized epilepsy and experiencing probable or possible PGTCS (with or without other subtypes of generalized seizures), and taking 1 to 3 anti-seizure medications (ASMs). Eligible subjects will be randomly assigned 1:1 to XEN1101 or placebo: subjects aged ≥ 18 years will receive XEN1101 25 mg or placebo, and subjects aged ≥12 years and \<18 years will receive either XEN1101 15 mg, 25 mg, or placebo. Randomization will be stratified based on region, age group, and background use of CYP3A4-inducer ASMs. Eligible subjects will have up to 9.5 weeks durations to assess the baseline frequency of seizures, followed by a double-blind treatment period (DBP) where subjects will receive 12 weeks of blinded treatment. During the DBP, subjects will be instructed to orally take XEN1101 or placebo once daily with an evening meal. Subjects who complete the 12-week DBP will have the opportunity to enroll in a separate open-label-extension (OLE) study for continued treatment with XEN1101. Subjects who do not enroll in the OLE will enter an 8-week post-treatment follow-up period.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 12 Years and over
- Who can join: All genders
What the study is looking for
- ✓Subject is ≥12 years of age with a 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...
- ✓Subject is on a stable dose of 1 to 3 allowable current ASMs for at least 3 months prior to the planned...
- ✓Subject is able to keep accurate seizure diaries.
Who cannot take part
- ✗Subject has had status epilepticus within the 12 months prior to Visit 1.
- ✗Subject has history of repetitive seizures within the 12-month period preceding Visit 1 where the individual...
- ✗Subject has a history of non-epileptic psychogenic seizures within 10 years prior to Visit 1.
- ✗Subject has a concomitant diagnosis of focal-onset seizures (FOS).
- ✗Subject has presence or history of a developmental and epileptic encephalopathy, including Lennox-Gastaut syndrome.
See the full criteria
Where Is This Study? (6 UK sites)
University Hospital of Wales
Cardiff CF14 4XW, United Kingdom
Mid Yorkshire Hospitals NHS Trust
Wakefield WF1 4DG, United Kingdom
St George's University Hospitals NHS Foundation Trust
London SW17 0QT, United Kingdom
University College London Hospitals NHS Foundation Trust
London WC1N 3BG, United Kingdom
Rajinder Sidhu - Associate Director, Research Governance and Operations
uclh.jro-communications@nhs.net020 3447 9825John Radcliffe Hospital
Oxford OX3 9DU, United Kingdom
Salford Royal NHS Foundation Trust - Greater Manchester Neuroscience Centre (GMNC)
Salford M6 8HD, United Kingdom
How to Get in Touch
Xenon Medical Affairs
Sponsor contactCONTACT
