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Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures (X-TOLE2)
EU CTIS ID: 2022-502000-73-00
What this study is testing
To assess the effect of XEN1101 versus placebo on reducing focal seizure frequency.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Subject is properly informed of the nature and risks of the study and gives informed consent in writing prior to entering the study.
- Subject has a diagnosis (≥2 years) of focal epilepsy according to the International League Against Epilepsy 2017 classification criteria. 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 is on a stable dose of 1 to 3 allowable current ASMs for at least 1 month prior to screening (Visit 1), during screening/baseline, and throughout the DBP.
- Subject is able to keep accurate seizure diaries.
You likely can't join if
- Subject has previously documented electroencephalogram which shows any pattern not consistent with focal etiology of seizures.
- Subject has history of focal aware non-motor seizures only
- Subject has a history of non-epileptic psychogenic seizures.
- Subject has history of a primary generalized seizure.
- Subject has presence or history of a developmental and epileptic encephalopathy, including Lennox-Gastaut syndrome.
- Subject has seizures secondary to drug or alcohol use, ongoing infection, neoplasia, demyelinating disease, degenerative neurological disease, metabolic illness, progressive structural lesion, encephalopathy, or progressive CNS disease.
See the full eligibility criteria
- Subject is properly informed of the nature and risks of the study and gives informed consent in writing prior to entering the study.
- Subject has a diagnosis (≥2 years) of focal epilepsy according to the International League Against Epilepsy 2017 classification criteria. 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 is on a stable dose of 1 to 3 allowable current ASMs for at least 1 month prior to screening (Visit 1), during screening/baseline, and throughout the DBP.
- Subject is able to keep accurate seizure diaries.
- Subject has previously documented electroencephalogram which shows any pattern not consistent with focal etiology of seizures.
- Subject has history of focal aware non-motor seizures only
- Subject has a history of non-epileptic psychogenic seizures.
- Subject has history of a primary generalized seizure.
- Subject has presence or history of a developmental and epileptic encephalopathy, including Lennox-Gastaut syndrome.
- Subject has seizures secondary to drug or alcohol use, ongoing infection, neoplasia, demyelinating disease, degenerative neurological disease, metabolic illness, progressive structural lesion, encephalopathy, or progressive CNS disease.
- Subject has history of status epilepticus or repetitive seizures within the 12-month period preceding Visit 1 where the individual seizures cannot be counted.
- Subject has history of neurosurgery for seizures <1 year prior to Visit 1, or radiosurgery <2 years prior to enrollment.
- Any medical condition or personal circumstance that, in the opinion of the investigator, exposes the subject to unacceptable risk by participating in the study or prevents adherence to the protocol
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- Georgia
- Mexico
- Argentina
- Chile
- Canada
- United States
- Australia
- New Zealand
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; Georgia; Mexico; Argentina; Chile; Canada and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.