A Multicenter, Open-label, Long-term, Safety, Tolerability, and Efficacy Study of XEN1101 in Adults Diagnosed With Epilepsy
Phuongthao Quan
Primary Investigator
Brief description of study
What is the purpose of this study?
To assess the safety and tolerability of XEN1101. 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.
Detailed description of study
What will happen during the study?
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.
Study drug is to be taken with the 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.
In total, subjects will undergo a treatment period of up to 156 weeks followed by an
8-week follow-up period.The total duration of this study will be 164 weeks, or approximately
38 months.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Epilepsy
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Age: 18 years - 100 years
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Gender: All
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. Subject must be willing to comply with the contraception requirements
4. Male subjects must agree not to donate sperm until 3 months after the last dose of study drug. Female subjects must agree not to donate ova until 6 months after the last dose of study drug.
5. 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.
6. 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. Female subject who is pregnant, breastfeeding, or planning to become pregnant prior to 6 months
after the last dose of study drug.
4. 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.
