The X-TOLE3 Phase 3 clinical trial is a randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment study that will measure the clinical how well it works, whether it is safe and how hard side effects are to live with of XEN1101 administered as added on top of your current treatment therapy in focal-onset seizures.
Official registry: https://clinicaltrials.gov/study/NCT05716100 · Xenon Pharmaceuticals Inc. · enrollment listed as 360
Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
If you join, the listed intervention(s) are XEN1101, or Placebo. The registry lists allocation as randomized. The X-TOLE3 Phase 3 clinical trial is a randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment study that will measure the clinical how well it works, whether it is safe and how hard side effects are to live with of XEN1101 administered as added on top of your current treatment therapy in focal-onset seizures.
They plan to enroll about 360 people at 103 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
A Randomized, Double-blind, Placebo-Controlled, Multicenter Phase 3 Study to Evaluate the Safety, Tolerability, and Efficacy of XEN1101 as Adjunctive Therapy in Focal-Onset Seizures
Interventions: XEN1101, Placebo
Primary outcome (registry wording): Median percent change (MPC) in focal seizure frequency from baseline to DBP for XEN1101 versus placebo.
Xenon Medical Affairs
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
+ 84 sites outside the US on the same record
Objective: This protocol is designed to allow the Surgical Neurology Branch to evaluate and treat the neurosurgical disorders of protocol participants. The participants will receive standard-of-clinical-care evaluation and treatment.
NCT00060541 · Official ClinicalTrials.gov record · National Institute of Neurological Disorders and Stroke (NINDS)
Background: \- Drug resistant epilepsy is the term used to describe epilepsy that cannot be controlled by medication. Many people whose seizures do not respond to medication will respond to surgical treatment, relieving seizures completely or almost completely in one-half to two-thirds of patients who qualify for surgery.
NCT01273129 · Official ClinicalTrials.gov record · National Institute of Neurological Disorders and Stroke (NINDS)
The Coordination of Rare Diseases at Sanford (CoRDS) is an international patient registry that serves as a centralized resource for rare disease research. Individuals affected by rare diseases, undiagnosed conditions, and disorders of unknown prevalence may voluntarily contribute health information to support natural history studies, participant recruitment, and other research efforts.
NCT01793168 · Official ClinicalTrials.gov record · Sanford Health
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary