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NCT05614063 (XEN1101 in Focal Onset Seizures): BVCT ex-ante prediction vs. reported outcome

On 6 Oct 2023, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 9 Mar 2026 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially sufficient.

Clinical Trial

NCTID
NCT05614063
Acronym
X-TOLE2
Drug Name
XEN1101
Drug MoA
Kv7.2/7.3 potassium channel opener
Drug Modality
small molecule
Drug Class
Best-In-Class
Therapeutic Area
Nervous System Diseases
Indication
Focal Onset Seizures
Human Patients
380
Sponsor
Xenon Pharmaceuticals
Phase
Phase 3

Prediction of , index 1052

Prospective Prediction
Prediction Index
1052
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient clinical benefit)
Technical Prediction
SUCCESS (statistically significant clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
885 days in advance
Readout Data Interpretation
azetukalner 25mg met primary endpoint with placebo-adjusted -42.8% (25mg) and -24.1% (15mg) median percent change in monthly FOS frequency (p<0.0001)
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially sufficient
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
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
Phase
Phase 3
Status
Completed
Enrollment
380
Lead sponsor
Xenon Pharmaceuticals Inc.
Conditions
Focal Onset Seizures
Interventions
DRUG: XEN1101; DRUG: Placebo
Design
Randomized · Parallel · Double
Primary purpose
Treatment
Start
2022-11-18
Primary completion
2026-01-12
Completion
2026-02-03
Primary outcomes
  • 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))

NCT05614063 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials