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NCT05667142 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate XEN1101 as Adjunctive Therapy in Primary Generalized Tonic-Clonic Seizures
A Phase 3 study of Primary Generalized Tonic-Clonic Seizures, sponsored by Xenon Pharmaceuticals.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 160
- Enrollment target
- 20
- Study locations
NCT05667142: Recruiting Phase 3 study of Primary Generalized Tonic-Clonic Seizures, sponsored by Xenon Pharmaceuticals.
NCT05667142 is a Phase 3 study of Primary Generalized Tonic-Clonic Seizures that is actively recruiting participants, run by Xenon Pharmaceuticals. The registered enrollment target is 160 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (79% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05667142, a Phase 3 study of Primary Generalized Tonic-Clonic Seizures, is actively recruiting participants, sponsored by Xenon Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 160 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the clinical efficacy, safety, and tolerability of XEN1101 administered as adjunctive treatment in primary generalized tonic-clonic seizures (PGTCS).
Primary Outcome
Median percent change (MPC) in monthly (28 days) PGTCS frequency from baseline through the DBP for XEN1101 versus placebo.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG XEN1101
Study Locations (20)
Florida
- Mayo Clinic Florida - Jacksonville
- Serenity Research Center, LLC - Miami
- Research Institute of Orlando, LLC - Orlando
- Panhandle Research and Medical Clinic - Pensacola
- Medsol Clinical Research Center Harbor Professional Centre - Port Charlotte
- University of South Florida - Tampa
- Encore Medical Research of Weston, LLC - Weston
California
- Brain Science Research Institute - Los Angeles
- University of California, Irvine - Health Neurology Services - Orange
- University California, Davis Clinical & Translation Science Center Clinical Research (CCRC) - Sacramento
Georgia
- Emory Brain Health Center - Atlanta
- Children's Healthcare of Atlanta - Atlanta
- Georgia Neurology & Sleep Medicine Associates - Suwanee
Arizona
- Xenoscience - Phoenix
- University of Arizona - Health Science Center - Tucson
Alabama
- University of Alabama - Strada Patient Care Center, Neurology - Mobile
Arkansas
- University of Arkansas for Medical Sciences - Little Rock
Colorado
- University of Colorado Anschutz Medical Campus - Aurora
Hawaii
- Hawaii Pacific Neuroscience, Comprehensive Epilepsy Center - Honolulu
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2023-02-14 |
| Est. Completion | 2027-06 |
| Phase | Phase 3 |
What NCT05667142 shows while recruiting
NCT05667142 is an interventional study that assigns participants to a tested intervention. The registered 160 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (79% lower).
The record links to 1 condition, with Primary Generalized Tonic-Clonic Seizures appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05667142 names 20 study sites across 9 states, led by Florida, California, Georgia.
Frequently Asked Questions
What is clinical trial NCT05667142 about?
NCT05667142 is a clinical study titled "A Study to Evaluate XEN1101 as Adjunctive Therapy in Primary Generalized Tonic-Clonic Seizures". This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the clinical efficacy, safety, and tolerability of XEN1101 administered as adjunctive treatment in primary generalized tonic-clonic seizures (PGTCS).
What is the current status of trial NCT05667142?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 160 participants. The study started on 2023-02-14. Estimated completion is 2027-06.
What conditions does trial NCT05667142 study?
This clinical trial studies the following conditions: Primary Generalized Tonic-Clonic Seizures.
What interventions are being tested in trial NCT05667142?
The interventions under investigation include: Placebo (DRUG), XEN1101 (DRUG).
Who is sponsoring clinical trial NCT05667142?
This trial is sponsored by Xenon Pharmaceuticals, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05667142 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05667142's enrollment target sits among peer trials
160 1480th of 2000 higher than 500 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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