An Open-label Study of XEN1101 in Epilepsy
- Summary
- This study will evaluate the long term safety, tolerability, pharmacokinetics (PK), and efficacy of XEN1101 in subjects with Focal Onset Seizures (FOS) or Primary Generalized Tonic-Clonic Seizures (PGTCS) for the treatment of seizures for up to 6 years.
- Acronym
- X-TOLE4
- Short title
- An Open-label Study of XEN1101 in Epilepsy
- Official title
- A Multicenter, Open-label, Long-term, Safety, Tolerability, and Efficacy Study of XEN1101 in Subjects Diagnosed With Epilepsy
- Control arm
- Open label
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Enrolling by invitation
- Phase
- Phase 3
- Study type
- Interventional
- Completion date
- 2033-06-01
- First posted
- 2023-02-08
- Registry last updated
- 2026-10-08
- Primary completion date
- 2033-04-01
- Start date
- 2023-04-25
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Xenon Pharmaceuticals Inc.
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT05718817
- ClinicalTrials.gov ID
- NCT05718817
- Registry record
- Open registry record
- Allocation
- Not applicable
- Model
- Single group
- Purpose
- Treatment
- Masking
- No masking
The adverse events
Timeframe: From the start of treatment in the open-label extension (OLE) study through 8 weeks after the last dose.
To assess the safety and tolerability of XEN1101
Change in monthly seizure rate
Timeframe: From baseline through the active extension treatment (Week 312).
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
Timeframe: From baseline through the active extension treatment (Week 312).
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)
Timeframe: From baseline through the active extension treatment (Week 312).
Improvement in Clinical Global Impression of Severity (CGI-S) scores over time.
Change in Patient Global Impression of Severity (PGI-S)
Timeframe: From baseline through the active extension treatment (Week 312).
Improvement in Patient Global Impression of Severity (PGI-S) scores over time.
Change in Quality of Life in Epilepsy Inventory (QOLIE-31)
Timeframe: From baseline through the active extension treatment (Week 312).
Change in the 31-Item Quality of Life in Epilepsy Inventory (QOLIE-31) over time.
- Sex
- All
- Age groups
- Children, Adults, Older adults
- Minimum age
- 12 Years
- Healthy volunteers
- No
- Subject must be properly informed of the nature and risks of the study and give informed consent in writing prior to entering the study (for adult subjects) and for adolescent subject's parent/legal guardian and subject gives informed consent or assent in writing prior to entering the study.
- Subject must have successfully completed the double-blind treatment period (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 adverse events (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.
- 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.
- XenosciencePhoenix, United States
- University of Arizona - Health SciencesTucson, United States
- Clinical Trials, IncLittle Rock, United States
- Brain Science Research InstituteLos Angeles, United States
- UC Irvine HealthOrange, United States
- University of California, Davis Clinical & Translational Science Center Clinical Research (CCRC)Sacramento, United States
- University of Colorado Hospital Anschutz Outpatient PavilionAurora, United States
- Mayo Clinic FloridaJacksonville, United States
- Serenity Research Center, LLCMiami, United States
- Research Institute of Orlando, LLCOrlando, United States
- Panhandle Research & Medical ClinicPensacola, United States
- University of South FloridaTampa, United States
- Encore Medical Research of Weston, LLCWeston, United States
- Hawaii Pacific NeuroscienceHonolulu, United States
- Consultants in Epilepsy and NeurologyBoise, United States
- Indiana University School of MedicineIndianapolis, United States
- The University of Kansas Medical CenterKansas City, United States
- Bluegrass Epilepsy Research, LLCLexington, United States
- Kentucky ClinicLexington, United States
- MMP NeurologyScarborough, United States
- University of Maryland Medical CenterBaltimore, United States
- Mid-Atlantic Epilepsy and Sleep CenterBethesda, United States
- Brigham and Women's HospitalBoston, United States
- UMass Chan Medical SchoolWorcester, United States
- University of Michigan HospitalsAnn Arbor, United States
And 127 more, listed on the interactive page.
Other registry identifiers
- 2022-502282-24-00
Related records
Drugs (1)
Collaborators (1)
- Worldwide Clinical Trials
Lead sponsors (1)
Conditions (3)
- Epilepsy
- Focal epilepsy Primary condition
- Visual epilepsy