Adult focal (partial onset) epilepsy MedDRA version: 21.1 Level: LLT Classification code 10065337 Term: Focal epilepsy System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Product Name: XEN1101
Product Code: XEN1101
Pharmaceutical Form: Capsule
INN or Proposed INN: XEN1101
Current Sponsor code: XEN1101
Concentration unit: mg milligram(s)
Concentration type: equal
Concen
Sponsors
Xenon Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Be properly informed of the nature and risks of the study and give informed consent in writing, prior to entering the study - BMI =65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: - History of pseudoseizures, psychogenic seizures, primary generalized seizure, or focal aware non-motor seizures only - Presence or previous history of Lennox-Gastaut syndrome - Seizures secondary to other diseases or conditions - History of repetitive seizures within the last 12 months where the individual seizures cannot be counted - History of neurosurgery for seizures 450 msec at baseline; family history of sudden death of unknown cause b. History of skin or retinal pigment epithelium abnormalities caused by ezogabine - Use of vigabatrin in the last 5 years without stable visual fields tested twice over the 12 months after the last dose of vigabatrin (patients stopping vigabatrin more than 5 years prior to screening, must have no vigabatrin-related visual field abnormalities confirmed by examination within the past 6 months - concomitant use of vigabatrin is not allowed) - 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 and acceptable hematology and LFT values (or discontinued felbamate no less than 49 days) prior to Screening - Have had multiple drug allergies or a severe drug reaction to an AED(s), including dermatological (e.g., Stevens-Johnson syndrome), hematological, or organ toxicity reactions - Current use of a ketogenic diet OPEN-LABEL EXTENSION - Patients who met any of the withdrawal criteria in the DBP - Any medical condition, personal circumstance, or ongoing adverse event that in the opinion of the Investigator exposes the patient to unacceptable risk by participating in the OLE, or prevents adherence to the protocol - Females who are pregnant, breastfeeding or planning to become pregnant until 6 months after the last dose of study drug - Patients planning to enter a clinical trial with a different investigational drug or plan to use any experimental device for treatment of epilepsy or any other medical condition
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To assess the efficacy of XEN1101 compared to placebo on focal seizure frequency in adults with focal epilepsy taking 1-3 antiepileptic drugs (AEDs) in the double-blind period (DBP). - To assess the safety and tolerability of XEN1101 in adults with focal epilepsy taking 1-3 AEDs in the DBP.;Secondary Objective: - To evaluate the 50% XEN1101 response rates in comparison to placebo in the DBP. - To evaluate trends in focal seizure frequency over time in the DBP. - To assess the effect of XEN1101 vs. placebo on seizure severity and impact in adults with focal epilepsy taking 1-3 AEDs in the DBP.;Primary end point(s): - Median percent change in monthly (28 days) focal seizure frequency from baseline to DBP for XEN1101 versus placebo - Severity and frequency of associated adverse events/serious adverse events (AEs/SAEs) - Clinically significant changes in clinical laboratory findings - Clinically significant changes in 12-lead ECG - Increase in suicide risk as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) including increase in suicidal thoughts or an attempt - Clinically significant changes in vital signs including blood pressure, pulse or weight - Clinically significant changes in urological symptoms including retention as measured by the American Urological Association (AUA) Symptom Index in the DBP.;Timepoint(s) of evaluation of this end point: When all enrolled participants have completed the DBP or withdrawn from the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Responders are defined as patients experiencing =50% reduction in monthly (28 days) focal seizure frequency from baseline to DBP. - Percent change from baseline in weekly focal seizure frequency for each week in the DBP - Clinical and Patient Global Impression of Change scores during the DBP.;Timepoint(s) of evaluation of this end point: When all enrolled participants have completed the DBP or withdrawn from the study | — |
Countries
Canada, Georgia, Germany, Italy, Moldova, Republic of, Spain, Ukraine, United Kingdom, United States
Contacts
Public ContactAlberto Viavattene
Pivotal S.L.U.
Outcome results
None listed