What side effects are associated with this type of intervention?

Common treatments for seizures, including antiepileptic drugs like carbamazepine, oxcarbazepine, levetiracetam, and zonisamide, often have side effects such as dizziness, fatigue, nausea, and headache. Specific side effects can vary: carbamazepine and oxcarbazepine may cause hyponatremia and rash, levetiracetam can lead to behavioral changes and irritability, and zonisamide might result in weight loss and kidney stones. Potassium channel modulators like XEN1101, being studied for their efficacy in treating seizures, may share similar side effects, including dizziness and fatigue, but specific side effects for XEN1101 are still under investigation.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of seizures, including those that act on various mechanisms such as sodium channels, GABA receptors, and calcium channels. While specific FDA approvals for potassium channel modulators like XEN1101 are not detailed in the provided context, other antiepileptic drugs (AEDs) such as lamotrigine, valproate, and levetiracetam have been widely used and studied. These drugs have shown efficacy in different types of epilepsy, including focal and generalized seizures. The SANAD trials highlighted lamotrigine and valproate as first-choice treatments for focal and generalized epilepsy, respectively, due to their favorable profiles in terms of time to treatment failure and seizure remission.

What other types of research exist?

Promising novel alternatives to XEN1101 for seizure treatment include cenobamate, which has shown encouraging efficacy in clinical trials, and ganaxolone, particularly for specific epilepsy syndromes like CDKL5 deficiency disorder. Both drugs offer new perspectives for epilepsy treatment and have been approved or are in advanced stages of clinical evaluation.

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XEN1101 for Epilepsy (X-TOLE4 Trial)

Phase 3

Waitlist Available

Research Sponsored by Xenon Pharmaceuticals Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Subject is planning to enter a clinical study with a different investigational drug or planning to use any experimental device for treatment of epilepsy or any other medical condition during the study and until 28 days after completion of this study.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline through the active extension treatment (week 156).

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial will test the safety and effectiveness of taking a 25 mg pill of XEN1101 in patients with specific types of seizures. The goal is to see if it can help control their seizures by affecting brain activity. Participants must have completed earlier related studies.

Who is the study for?

This trial is for individuals with Focal Onset Seizures or Primary Generalized Tonic-Clonic Seizures who have completed a previous study without early termination or significant issues. Participants must be able to follow the study's instructions, keep accurate seizure diaries, and provide informed consent.

What is being tested?

The trial is testing the long-term safety and effectiveness of XEN1101, taken orally once daily at a dose of 25 mg. It aims to treat seizures in patients with certain types of epilepsy over a period of up to three years.

What are the potential side effects?

While specific side effects are not listed here, participants will be monitored for any adverse reactions related to XEN1101 throughout the course of treatment, focusing on its tolerability and any potential impact on seizure control.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am not planning to join another drug study or use an experimental device for my epilepsy or any other condition during this study and for 28 days after.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline through the active extension treatment (week 156).

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline through the active extension treatment (week 156).

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline through the active extension treatment (week 156). for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The adverse events

Secondary study objectives

Change in Clinical Global Impression of Severity (CGI-S)

Change in Patient Global Impression of Severity (PGI-S)

Change in Quality of Life in Epilepsy Inventory (QOLIE-31)

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups

Experimental Treatment

Group I: XEN1101 25 mg/dayExperimental Treatment1 Intervention

XEN1101 25 mg/day

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Antiepileptic drugs (AEDs) work through various mechanisms to control seizures. Common mechanisms include modulation of ion channels, enhancement of inhibitory neurotransmission, and reduction of excitatory neurotransmission. For example, XEN1101, a potassium channel modulator, stabilizes neuronal activity by enhancing the function of potassium channels, which helps to prevent excessive neuronal firing that leads to seizures. Understanding these mechanisms is crucial for patients as it helps in selecting the most appropriate treatment based on the type of epilepsy and individual response, thereby improving seizure control and minimizing side effects.

[How do antiepileptic drugs work?].