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An Open-label Study of XEN1101 in Epilepsy

Enrolling By InvitationPhase 3

Sponsor: Xenon Pharmaceuticals Inc.

Conditions: Focal Epilepsy, Tonic-Clonic Seizures

Interventions: XEN1101

Countries: United States, Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Chile

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.

Eligibility overview

Sex: ALL

Age: 12 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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 (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.
2. 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.
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.

Locations (151)

Phoenix, Arizona, United States
Tucson, Arizona, United States
Little Rock, Arkansas, United States
Los Angeles, California, United States
Orange, California, United States
Sacramento, California, United States
Aurora, Colorado, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Pensacola, Florida, United States
Tampa, Florida, United States
Weston, Florida, United States
Honolulu, Hawaii, United States
Boise, Idaho, United States
Indianapolis, Indiana, United States
Kansas City, Kansas, United States
Lexington, Kentucky, United States
Lexington, Kentucky, United States
Scarborough, Maine, United States
Baltimore, Maryland, United States
Bethesda, Maryland, United States
Boston, Massachusetts, United States
Worcester, Massachusetts, United States
Ann Arbor, Michigan, United States
Detroit, Michigan, United States
East Lansing, Michigan, United States
Grand Rapids, Michigan, United States
Burnsville, Minnesota, United States
St Louis, Missouri, United States
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