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An Open-label Study of XEN1101 in Epilepsy
EU CTIS ID: 2022-502282-24-00
What this study is testing
To assess the safety and tolerability of long-term therapy with XEN1101 in subjects with FOS or PGTCS who have completed Study XPF-010-301, XPF-010-302, or XPF-010-303.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Subject must have successfully completed the Double bling 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 AEs (in the opinion of the investigator) that would preclude the subject’s entry into the long-term extension study.
- Subject is able to keep accurate seizure diaries.
- 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 be willing to comply with the contraception requirements as defined in protocol Section 5.3.
- 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.
- 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.
You likely can't join if
- 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.
- Female subject who is pregnant, breastfeeding, or planning to become pregnant prior to 6 months after the last dose of study drug.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Chile
- Georgia
- Mexico
- New Zealand
- Argentina
- Australia
- Canada
- United States
- Israel
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chile; Georgia; Mexico; New Zealand; Argentina; Australia and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.