← Back to Search

XEN1101 for Seizures (X-ACKT Trial)

Phase 3
Recruiting
Research Sponsored by Xenon Pharmaceuticals Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from screening through to 56 days post-final dose
Awards & highlights

X-ACKT Trial Summary

This trial tests a new drug to treat primary generalized tonic-clonic seizures and assess its safety, efficacy and tolerability.

Who is the study for?
This trial is for adults over 18 with a BMI ≤40 who have generalized epilepsy with tonic-clonic seizures despite trying at least two anti-seizure medications. They must be on a stable dose of their current meds and able to track their seizures. Excluded are those with recent severe seizure episodes, non-epileptic psychogenic seizures, or significant mental health issues.Check my eligibility
What is being tested?
The study tests XEN1101 as an additional treatment for epilepsy against a placebo in a double-blind setup, meaning neither the participants nor the researchers know who's getting the real drug versus the placebo during the trial.See study design
What are the potential side effects?
While specific side effects aren't listed here, typical ones from similar epilepsy drugs can include dizziness, fatigue, balance issues, gastrointestinal discomforts like nausea or vomiting, and potential allergic reactions.

X-ACKT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from screening through to 56 days post-final dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and from screening through to 56 days post-final dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Median percent change (MPC) in monthly (28 days) PGTCS frequency
Secondary outcome measures
Proportion of subjects
Other outcome measures
Incidence of adverse events

X-ACKT Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: XEN1101 25 mg/dayExperimental Treatment1 Intervention
XEN1101 25 mg/day
Group II: XEN1101 15 mg/dayExperimental Treatment1 Intervention
XEN1101 15 mg/day
Group III: PlaceboPlacebo Group1 Intervention
Placebo

Find a Location

Who is running the clinical trial?

Xenon Pharmaceuticals Inc.Lead Sponsor
17 Previous Clinical Trials
2,755 Total Patients Enrolled
5 Trials studying Seizures
1,616 Patients Enrolled for Seizures
Worldwide Clinical TrialsOTHER
61 Previous Clinical Trials
14,227 Total Patients Enrolled
3 Trials studying Seizures
1,600 Patients Enrolled for Seizures
Medical DirectorStudy DirectorXenon Pharmaceuticals Inc.
2,777 Previous Clinical Trials
8,063,580 Total Patients Enrolled
3 Trials studying Seizures
1,307 Patients Enrolled for Seizures

Media Library

XEN1101 15 mg/day Clinical Trial Eligibility Overview. Trial Name: NCT05667142 — Phase 3
Seizures Research Study Groups: Placebo, XEN1101 15 mg/day, XEN1101 25 mg/day
Seizures Clinical Trial 2023: XEN1101 15 mg/day Highlights & Side Effects. Trial Name: NCT05667142 — Phase 3
XEN1101 15 mg/day 2023 Treatment Timeline for Medical Study. Trial Name: NCT05667142 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the 25 mg/day dosage of XEN1101 received authorization from the Food and Drug Administration?

"Our assessment of XEN1101 25 mg/day's safety is a 3 since there are multiple rounds of evidence demonstrating its efficacy and the trial itself has reached Phase 3."

Answered by AI

How widely has this trial been disseminated across medical centers?

"Hawaii Pacific Neuroscience, Comprehensive Epilepsy Center in Honolulu, Mid-Atlantic Epilepsy and Sleep Centre in Bethesda, and Dent Neurosciences Research Facility in Amherst are just a handful of the sites running this study."

Answered by AI

Is recruitment for this research endeavor still taking place?

"Affirmative. Information available through clinicaltrials.gov indicates that recruitment for this medical experiment is ongoing, having been initially posted on February 1st 2023 and last updated on the 27th of February 2023. The goal is to have 160 participants enrolled across 4 different sites."

Answered by AI

How many volunteers are participating in this experiment?

"Affirmative. According to the information hosted on clinicaltrials.gov, this medical trial is currently in search of participants since it was initially posted on February 1st 2023 and updated lastly on February 27th 2023. Aspiring subjects must come from one of four different facilities as 160 patients are desired for recruitment."

Answered by AI

Who else is applying?

What site did they apply to?
Southern Illinois University School of Medicine
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate XEN1101 as Adjunctive Therapy in Primary Generalized Tonic-Clonic Seizures
2023. "A Study to Evaluate XEN1101 as Adjunctive Therapy in Primary Generalized Tonic-Clonic Seizures". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05667142.
All > Honolulu
~77 spots leftby Jun 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top