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, followed by an optional open-label extension (OLE).
The XEN1101 Phase 2 clinical trial is designed as a randomized, double-blind, placebo-controlled, multicenter study with an optional open-label extension (OLE) to evaluate the clinical efficacy, safety and tolerability of XEN1101 administered as adjunctive treatment in adult patients aged 18 to 75 years diagnosed with focal epilepsy. Approximately 300 patients will be randomized in a blinded manner to one of three active treatment groups or placebo in a 2:1:1:2 fashion (XEN1101 25 mg : 20 mg : 10 mg : Placebo). After screening, patients will have 8 weeks of baseline to assess frequency of seizures, followed by 8 weeks of treatment and a 6-week post treatment follow-up period. In order to be included in the study, patients must already be treated with a stable dose of 1 to 3 allowable current anti-epileptic drugs for at least one month prior to screening, during baseline, and throughout the double-blind portion (DBP) of the study. During the treatment period, patients will be given XEN1101 or placebo once daily in the evening. An OLE will be available to eligible patients who complete the DBP. All patients will receive a 20 mg daily dose of XEN1101 during this extension period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
325
Oral dose
Median Percent Change in Focal Seizure Frequency
Median percent change in monthly (28 days) focal seizure frequency from baseline to DBP for XEN1101 versus placebo
Time frame: From baseline (8 weeks prior to Day 0) through to the final dose (up to Day 56)
50% XEN1101 Response Rate
Responders are defined as patients experiencing ≥50% reduction in monthly (28 days) focal seizure frequency from baseline to DBP
Time frame: From baseline (8 weeks prior to Day 0) through to the final dose (up to Day 56)
Percent Change in Focal Seizure Frequency Over Time
Percent change from baseline in focal seizure frequency at Month 1 and Month 2 in the DBP
Time frame: From baseline (8 weeks prior to Day 0) through to the final dose (up to Day 56)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University of Alabama at Birmingham
Birmingham, Alabama, United States
Strada Patient Care Center
Mobile, Alabama, United States
Xenoscience, Inc.
Phoenix, Arizona, United States
Clinical Trials, Inc.
Little Rock, Arkansas, United States
Altman Clinical Translational Research Institute (ACTRI)
La Jolla, California, United States
California Pacific Medical Center (CPMC) - Sutter Pacific Epilepsy Program
San Francisco, California, United States
University of Colorado Hospital Anschutz Outpatient Pavilion
Aurora, Colorado, United States
University of Florida Jacksonville
Jacksonville, Florida, United States
Mayo Clinic Florida
Jacksonville, Florida, United States
Visionary Investigators Network
Miami, Florida, United States
...and 85 more locations