A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of XEN1101 as Adjunctive Therapy in Focal-onset Epilepsy
The XEN1101 Phase 2 clinical trial is a randomized, double-blind, placebo-controlled study that will evaluate the clinical efficacy, safety and tolerability of increasing doses of XEN1101 administered as adjunctive treatment in adult patients diagnosed with focal epilepsy
Key Inclusion Criteria:
-Diagnosis (≥2 years) of focal epilepsy.
-Treatment with a stable dose of 1 to 3 allowable current AEDs for at least one month prior to screening, during baseline, and throughout the duration of the study.
-Able to keep accurate seizure diaries.
Key Exclusion Criteria:
-History of neurosurgery for seizures <1 year prior to enrollment, or radiosurgery <2 years prior to enrollment.
-Concomitant use of vigabatrin or a ketogenic diet. If felbamate is used as a concomitant AED, patients must be taking it for at least 2 years, with a stable dose for ≥49 days.
**Other protocol-defined inclusion/exclusion criteria may apply. Please click on the NCT Number (below) to learn more about the study at clinicaltrials.gov.**
Evan Fertig, M.D.
Xenon Pharmaceuticals Inc.
- Providence Portland Medical Center
- Providence St. Vincent Medical Center