X-TOLE: XEN1101 as Adjunctive Therapy in Focal-onset Epilepsy, with an Open-Label Extension
The X-TOLE Study is a phase 2 double-blind study that is underway for patients with focal epilepsy currently taking between 1 and 3 anti-epileptic drugs that are still experiencing frequent seizures.
Three doses of the investigational drug are being evaluated and some patients will be assigned to a placebo. The study includes a 2-month baseline and a 2-month randomized, double-blind treatment period followed by an optional open-label extension phase for up to 1 year.
All participants will receive active study on the extension study.
To participate in the trial, you must meet certain criteria. The following details only some of these requirements.
Inclusion Criteria
- 18 to 75 years old
- Able to keep accurate seizure diaries
- Have a diagnosis of focal/partial epilepsy for at least 2 years
- On a stable dose of 1 to 3 anti-epileptic drugs
- BMI <37 kg/m2
Exclusion Criteria
- Have a history of primary generalized seizures
- Repetitive seizures within the past year where the individual seizure cannot be counted
- Status epilepticus within the past year
How the drug works
XEN1101 is a Kv7 potassium channel modular being developed for the treatment of focal epilepsy. It’s mechanism has been clinically validated as an effective adjunctive therapy for treatment-resistant focal seizures as demonstrated with ezogabine, an earlier generation Kv7 opener.
If you would like more information or to find out if you are eligible to participate please contact Jennifer Cox at 716-250-7002.
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