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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05718817
Other study ID # XPF-010-304
Secondary ID
Status Enrolling by invitation
Phase Phase 3
First received
Last updated
Start date April 25, 2023
Est. completion date September 2028

Study information

Verified date March 2024
Source Xenon Pharmaceuticals Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will evaluate the long term safety, tolerability, PK, and efficacy of XEN1101 25 mg QD taken orally in subjects with Focal Onset Seizures (FOS) or Primary Generalized Tonic-Clonic Seizures (PGTCS) for the treatment of seizures for up to 3 years.


Description:

This is an Open Label Extension study of the following Phase 3 clinical studies: XPF-010-301 (X-TOLE2), XPF-010-302 (X-TOLE3), and XPF-010-303 (X-ACKT). This study will evaluate the long term safety, tolerability, PK, and efficacy of XEN1101 25 mg QD taken orally once daily (QD) in subjects with FOS or PGTCS for the treatment of seizures for up to 3 years. Subjects who successfully completed and did not terminate early from one of the antecedent studies (X-TOLE2, X-TOLE3, or X-ACKT) are eligible to participate in X-TOLE4. Following enrollment into X-TOLE4, subjects will undergo a treatment period of up to 3 years, during which there will be a visit at 2-, 4-, and 13-weeks post-entry, with subsequent visits occurring at 13 week intervals during the first year, and then at 26-week intervals (with a telephone call in between) until dosing is completed. All subjects will be initially assigned to receive 25 mg QD of XEN1101. Subjects will be instructed to orally take XEN1101 once daily with an evening meal. Subjects will be expected to keep a daily seizure eDiary with a minimum of 80% compliance for the duration of the extension study (reporting on ≥80% of days between visits). Upon completion of dosing at the end of the treatment period, there will be an 8-week follow up period.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 880
Est. completion date September 2028
Est. primary completion date July 2028
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Subject must be properly informed of the nature and risks of the study and give informed consent in writing, prior to entering the study. 2. Subject must have successfully completed the DBP and have not terminated early from Study X-TOLE2, X-TOLE3, or X-ACKT, met all eligibility requirements, and had no important protocol deviations (in the opinion of the sponsor) or AEs (in the opinion of the investigator) that would preclude the subject's entry into the long-term extension study. 3. In the opinion of the investigator, the subject is able to understand verbal and written instructions and will adhere to all study schedules and requirements. 4. Subject is able to keep accurate seizure diaries. Exclusion Criteria: 1. Subject met any of the withdrawal criteria while in Study X-TOLE2, X-TOLE3, or X-ACKT. 2. Subject has any medical condition, personal circumstance, or ongoing AE (from Study X-TOLE2, X-TOLE3, or X-ACKT) that, in the opinion of the investigator, exposes the subject to unacceptable risk by participating in the study, or prevents adherence to the protocol. 3. Subject is planning to enter a clinical study with a different investigational drug or planning to use any experimental device for treatment of epilepsy or any other medical condition during the study and until 28 days after completion of this study.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
XEN1101
XEN1101 capsules

Locations

Country Name City State
Canada Center for Neurologic Research Lethbridge Alberta
Poland NZOZ Neuromed M. i M. Lublin
Spain Hospital Clinico San Carlos Madrid
United States Mid-Atlantic Epilepsy and Sleep Center Bethesda Maryland
United States Dent Neurosciences Research Center Buffalo New York
United States Michigan State University East Lansing Michigan
United States Northeast Epilepsy Group Hackensack New Jersey
United States Hawaii Pacific Neuroscience Honolulu Hawaii
United States Kentucky Clinic Lexington Kentucky
United States Clinical Trials, Inc Little Rock Arkansas
United States New York University Comprehensive Epilepsy Center New York New York
United States Research Institute of Orlando, LLC Orlando Florida
United States Panhandle Research & Medical Clinic Pensacola Florida
United States Thomas Jefferson University Philadelphia Pennsylvania
United States University of Utah Clinical Neurosciences Center Salt Lake City Utah
United States MMP Neurology Scarborough Maine
United States University of Washington Main Hospital Seattle Washington
United States SUNY Upstate Medical University Syracuse New York

Sponsors (2)

Lead Sponsor Collaborator
Xenon Pharmaceuticals Inc. Worldwide Clinical Trials

Countries where clinical trial is conducted

United States,  Canada,  Poland,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary The adverse events To assess the safety and tolerability of XEN1101 From the start of treatment in the OLE study through 8 weeks after the last dose.
Secondary Change in monthly seizure rate Percent change in monthly seizure rate recorded at baseline (in the antecedent studies) compared to each 4-week assessment period in the treatment period in X-TOLE4. From baseline through the active extension treatment (Week 156).
Secondary Proportion of responders Proportion of responders (subjects experiencing =50% reduction in seizure frequency from baseline) in each consecutive 4-week assessment period of the treatment period of the OLE study. From baseline through the active extension treatment (Week 156).
Secondary Change in Clinical Global Impression of Severity (CGI-S) Improvement in Clinical Global Impression of Severity (CGI-S) scores over time. From baseline through the active extension treatment (Week 156).
Secondary Change in Patient Global Impression of Severity (PGI-S) Improvement in Patient Global Impression of Severity (PGI-S) scores over time. From baseline through the active extension treatment (Week 156).
Secondary Change in Quality of Life in Epilepsy Inventory (QOLIE-31) Change in the 31-Item Quality of Life in Epilepsy Inventory (QOLIE-31) over time. From baseline through the active extension treatment (Week 156).
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