XEN1101 for Partial Seizures

Recruiting at 74 trial locations

Overseen By Xenon Medical Affairs

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Xenon Pharmaceuticals Inc.

Must be taking: Antiseizure medications

Disqualifiers: Generalized seizures, Psychogenic seizures, others

Stay on Your Current Meds You can continue your current medications while participating

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

360 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called XEN1101 to determine if it can reduce seizures in people with focal epilepsy. The study compares different doses of XEN1101 against a placebo (a pill with no active medicine) to assess its effectiveness and safety when added to current treatments. Participants must have had focal epilepsy for at least 2 years and experienced seizures despite trying other medications. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial requires that you stay on a stable dose of 1 to 3 of your current seizure medications for at least one month before starting and throughout the study.

Is there any evidence suggesting that XEN1101 is likely to be safe for humans?

Research has shown that XEN1101 has been tested for safety in treating focal-onset seizures. Previous studies found that XEN1101 is generally well-tolerated. Some patients experienced side effects, but these were mostly mild to moderate.

For example, one study reported that dizziness and sleepiness were the most common side effects. These were not severe for most people and often resolved over time. Another study found that patients taking XEN1101 for up to two years maintained a stable safety profile, with no unexpected problems occurring over the long term.

Overall, the evidence suggests XEN1101 is fairly safe for most people in treating focal-onset seizures. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for seizures?

Researchers are excited about XEN1101 for partial seizures because it introduces a novel mechanism of action by targeting potassium channels to stabilize neuronal activity. This is different from most existing treatments like sodium channel blockers and GABA enhancers, which don't directly target potassium channels. By offering a new pathway to control seizures, XEN1101 has the potential to provide relief for patients who may not respond well to conventional therapies. Additionally, the distinct dosing options of 15 mg/day and 25 mg/day may allow for personalized treatment approaches, optimizing efficacy and minimizing side effects.

What evidence suggests that XEN1101 might be an effective treatment for partial seizures?

Research has shown that XEN1101, which participants in this trial may receive, can greatly reduce the frequency of focal-onset seizures. In one study, many patients experienced at least a 50% reduction in seizure frequency when taking XEN1101 compared to those on a placebo. This medication works by opening specific potassium channels in the brain, helping to stabilize nerve activity. Long-term research indicates that XEN1101 remains effective over time, with many patients experiencing ongoing relief from seizures. These findings suggest that XEN1101 could be a promising option for people with partial seizures. ^{1 2 3 4 5}

Who Is on the Research Team?

Xenon Medical Director

Principal Investigator

Xenon Pharmaceuticals Inc.

Are You a Good Fit for This Trial?

This trial is for adults with focal epilepsy diagnosed at least 2 years ago, who've tried and not responded to at least two anti-seizure medications (ASMs). They must be on a stable dose of 1-3 ASMs currently. Participants need to provide informed consent, have no history of certain non-focal seizures or neurosurgery within specific time frames, and can't have seizures from other medical conditions.

Inclusion Criteria

I have been on 1 to 3 approved seizure medications for at least a month.

You can accurately keep track of your seizures in a diary.

Be properly informed of the nature and risks of the study and give informed consent in writing, prior to entering the study

Exclusion Criteria

I do not have seizures caused by substance use, infections, cancer, or other listed conditions.

I have had uncountable seizures or status epilepticus in the last year.

I had neurosurgery for seizures less than a year ago or radiosurgery less than two years ago.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Assessment of seizure frequency over a period of up to 9.5 weeks

9.5 weeks

Treatment

Participants receive XEN1101 or placebo once daily for 12 weeks

12 weeks

Regular visits for monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

Open-label extension (optional)

Participants may opt into continuation of treatment with XEN1101 long-term

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• XEN1101

Trial Overview The X-TOLE3 study tests the effectiveness and safety of XEN1101 as an additional treatment for focal-onset seizures compared to a placebo. It's randomized (participants are assigned by chance) and double-blind (neither participants nor researchers know who gets what), ensuring unbiased results.

How Is the Trial Designed?

Group I: XEN1101 25 mg/day Experimental Treatment 1 Intervention

XEN1101 25 mg/day

Group II: XEN1101 15 mg/day Experimental Treatment 1 Intervention

XEN1101 15 mg/day

Group III: Placebo Placebo Group 1 Intervention

Placebo

Who Is Running the Clinical Trial?

Xenon Pharmaceuticals Inc.

Lead Sponsor

Trials

19

Recruited

3,400+

Worldwide Clinical Trials

Collaborator

Trials

70

Recruited

15,800+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37812429/

Efficacy and Safety of XEN1101, a Novel Potassium ... To evaluate the efficacy and safety of XEN1101, a novel small-molecule selective Kv7.2/Kv7.3 potassium channel opener, in the treatment of focal-onset seizures ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40053315/

Long-term Efficacy & Safety of Azetukalner for Focal Epilepsy This long-term study assessed the safety and efficacy of azetukalner to treat focal seizures. Patients taking azetukalner daily with food for about 2 years ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05716100

A Randomized Study of XEN1101 Versus Placebo in Focal ... Proportion of subjects experiencing ≥50% reduction in focal seizure frequency from baseline through the DBP for XEN1101 versus placebo. From baseline through to ...

4. investor.xenon-pharma.com investor.xenon-pharma.com/news-releases/news-release-details/xenon-showcases-new-long-term-azetukalner-data-x-tole-ole-study

Xenon Showcases New Long-Term Azetukalner Data from X ... OLE data shows sustained monthly reduction in seizure frequency, impressive seizure freedom rates, and consistent AE safety profile suggesting long-term ...

5. xenon-pharma.com xenon-pharma.com/wp-content/uploads/2024/04/xen1101-clinical-trial-brochure.pdf

XEN1101 Clinical Trial Brochure A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Safety and. Efficacy of XEN1101 as an Adjunctive Therapy in the Treatment of ...