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Compares treatment options for Focal Onset Seizures
Official title A Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures (X-TOLE3)
ClinicalTrials.gov ID: NCT05716100
What this study is testing
What is XEN1101?
XEN1101 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for focal onset seizures.
Also referred to as Azetukalner.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The X-TOLE3 Phase 3 clinical trial is a randomized, double-blind, placebo-controlled study that will evaluate the clinical efficacy, safety and tolerability of XEN1101 administered as adjunctive therapy in focal-onset seizures.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Be properly informed of the nature and risks of the study and give informed consent in writing, prior to entering the study
- Diagnosis (≥2 years) of focal epilepsy according to the International League Against Epilepsy (ILAE) Classification of Epilepsy (2017). Subject must...
- Treatment with a stable dose of 1 to 3 allowable current ASMs for at least one month prior to screening, during baseline, and throughout the duration...
- Able to keep accurate seizure diaries
You likely can't join if
- Previously documented electroencephalogram which shows any pattern not consistent with focal etiology of seizures.
- History of focal aware non-motor seizures only, non-epileptic psychogenic seizure, primary generalized seizure, developmental and epileptic...
- Seizures secondary to drug or alcohol use, ongoing infection, neoplasia, demyelinating disease, degenerative neurological disease, metabolic illness...
- History of status epilepticus or repetitive seizures within the 12-month period preceding Visit 1 where the individual seizures cannot be counted.
- History of neurosurgery for seizures \<1 year prior to Visit 1, or radiosurgery \<2 years prior to enrollment.
- Any medical condition or personal circumstance that, in the opinion of the investigator, exposes the subject to unacceptable risk by participating in...
The study team makes the final eligibility decision.
Where it's taking place
- Little Rock, Arkansas, United States
- Downey, California, United States
- Los Angeles, California, United States
- Orange, California, United States
- Gulf Breeze, Florida, United States
- Jacksonville, Florida, United States
- Boise, Idaho, United States
- Springfield, Illinois, United States
- Bethesda, Maryland, United States
- Detroit, Michigan, United States
- Hackensack, New Jersey, United States
- Woodmere, New York, United States
- Durham, North Carolina, United States
- Cleveland, Ohio, United States
- Columbus, Ohio, United States
- Portland, Oregon, United States
- Nashville, Tennessee, United States
- Austin, Texas, United States
- Salt Lake City, Utah, United States
- Buenos Aires, Argentina
+ 55 more site(s).
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Little Rock, Arkansas, United States; Downey, California, United States; Los Angeles, California, United States; Orange, California, United States; Gulf Breeze, Florida, United States; Jacksonville, Florida, United States and 69 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 ClinicalTrials.gov; the study team decides eligibility.