An Open-label Study of XEN1101 in Epilepsy - Clinical Trial for Focal Epilepsy | NCT05718817

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Primary Purpose

Status

Enrolling by invitation

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

XEN1101

About this trial

This is an interventional treatment trial for Focal Epilepsy focused on measuring Epilepsy, Seizures

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Subject must be properly informed of the nature and risks of the study and give informed consent in writing, prior to entering the study. 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. 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. Subject is able to keep accurate seizure diaries. Exclusion Criteria: Subject met any of the withdrawal criteria while in Study X-TOLE2, X-TOLE3, or X-ACKT. 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. 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.

Sites / Locations

Northeast Epilepsy Group
Dent Neurosciences Research Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

XEN1101 25 mg/day

Arm Description

XEN1101 25 mg/day

Outcomes

Primary Outcome Measures

The adverse events

To assess the safety and tolerability of XEN1101

Secondary Outcome Measures

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.

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.

Change in Clinical Global Impression of Severity (CGI-S)

Improvement in Clinical Global Impression of Severity (CGI-S) scores over time.

Change in Patient Global Impression of Severity (PGI-S)

Improvement in Patient Global Impression of Severity (PGI-S) scores over time.

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.

Full Information

NCT ID

NCT05718817

First Posted

January 13, 2023

Last Updated

June 5, 2023

Sponsor

Xenon Pharmaceuticals Inc.

Collaborators

Worldwide Clinical Trials

1. Study Identification

Unique Protocol Identification Number

NCT05718817

Brief Title

An Open-label Study of XEN1101 in Epilepsy

Acronym

X-TOLE4

Official Title

A Multicenter, Open-label, Long-term, Safety, Tolerability, and Efficacy Study of XEN1101 in Adults Diagnosed With Epilepsy

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Enrolling by invitation

Study Start Date

April 25, 2023 (Actual)

Primary Completion Date

June 2026 (Anticipated)

Study Completion Date

June 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Xenon Pharmaceuticals Inc.

Collaborators

Worldwide Clinical Trials

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Focal Epilepsy, Tonic-Clonic Seizures

Keywords

Epilepsy, Seizures

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

880 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

XEN1101 25 mg/day

Arm Type

Experimental

Arm Description

XEN1101 25 mg/day

Intervention Type

Drug

Intervention Name(s)

XEN1101

Intervention Description

XEN1101 capsules

Primary Outcome Measure Information:

Title

The adverse events

Description

To assess the safety and tolerability of XEN1101

Time Frame

From the start of treatment in the OLE study through 8 weeks after the last dose.

Secondary Outcome Measure Information:

Title

Change in monthly seizure rate

Description

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.

Time Frame