A Randomized Study of XEN1101 Versus Placebo in Focal-Onset Seizures

NCT05614063 · X-TOLE2 Phase 3Completed

Lead sponsor
Xenon Pharmaceuticals Inc. (Industry)
Enrollment
380 (actual)
Start date
18 Nov 2022
Primary completion
12 Jan 2026 (actual)
Study completion
3 Feb 2026
Last update posted
14 May 2026

Design

Study type
Interventional
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel
Masking
Double
Arms
3

Interventions

  • XEN1101 Drug
  • Placebo Drug

Conditions and primary outcome

  • Focal Onset Seizures

Primary outcome

Median percent change (MPC) in monthly (28 days) focal seizure frequency from baseline to DBP for XEN1101 versus placebo. (From baseline through to the double blind period (week 12))

Posted results on ClinicalTrials.gov

Results posted on ClinicalTrials.gov: No

Results from company and journal sources

No editor-confirmed results are on record for this study.

Publications

No PubMed citation lists NCT05614063.

CT-VCA trial quality

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Data integrity

Compare what the registry, company releases, FDA documents and publications say about this study.

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Source

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.

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