What side effects are associated with this type of intervention?

Common treatments for seizures, including potassium channel modulators like XEN1101, often have side effects such as dizziness, fatigue, headache, and somnolence. Other antiepileptic drugs (AEDs) may cause side effects like nausea, weight gain, mood changes, and cognitive impairment. Specific AEDs can also have unique side effects; for example, carbamazepine can cause hyponatremia, and valproate can lead to liver toxicity and weight gain. It is important for patients to discuss potential side effects with their healthcare provider to manage and mitigate these risks effectively.

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 the context does not provide specific information on potassium channel modulators like XEN1101, it mentions other treatments such as cannabidiol, topiramate, and valproate, which have been studied for their efficacy and safety in different types of epilepsy. These treatments have shown varying degrees of success in clinical trials, with some being more effective for specific epilepsy syndromes. For instance, cannabidiol has been approved for treatment-resistant epilepsy, and topiramate has been used as an add-on therapy in severe myoclonic epilepsy.

What other types of research exist?

Promising novel alternatives to XEN1101 for seizure patients include Cenobamate, which has shown encouraging efficacy in clinical trials, and Ganaxolone, particularly for specific epilepsy syndromes like CDKL5 deficiency disorder. Both drugs have demonstrated potential in recent studies and may offer new treatment options in 2024.

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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

Pivotal Trial

Summary

This trial tests XEN1101, a medication added to current treatments, in people with generalized epilepsy experiencing PGTCS who are already on 1-3 anti-seizure medications. The goal is to see if taking XEN1101 with an evening meal can help reduce seizure frequency.

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from screening through to 56 days post-final dose

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

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

Primary study objectives

Median percent change (MPC) in monthly (28 days) PGTCS frequency

Secondary study objectives

Proportion of subjects

Other study objectives

Incidence of adverse events

Awards & Highlights

Pivotal Trial

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

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

XEN1101

2021

Completed Phase 2

~50

Do I qualify?Apply below to find out

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 stabilize neuronal activity and prevent seizures. Potassium channel modulators like XEN1101 enhance the activity of potassium channels, helping to stabilize the neuronal membrane and reduce excitability. Sodium channel blockers, such as carbamazepine and lamotrigine, inhibit the repetitive firing of neurons by stabilizing inactive sodium channels. GABA enhancers, including benzodiazepines and valproate, increase the inhibitory effects of GABA neurotransmitters, reducing neuronal excitability. Calcium channel blockers, like ethosuximide, reduce the influx of calcium ions, which is crucial for neurotransmitter release and neuronal firing. Understanding these mechanisms is vital for patients as it helps tailor treatment plans to individual needs, potentially improving seizure control and minimizing side effects.

[How do antiepileptic drugs work?].