Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Randomized, Double-blind, Placebo-Controlled, Multicenter Phase 3 Study to Evaluate the Safety, Tolerability, and Efficacy of XEN1101 as Adjunctive Therapy in Focal-Onset Seizures

This important study is looking into a new medication called XEN1101 for people who experience focal-onset seizures. These are seizures that start in one part of the brain. The main goal is to find out if XEN1101 can significantly lower the number of seizures a person has each month, compared to taking a placebo, which is a dummy pill with no active drug. This type of study, known as a Phase 3 trial, is a big step. It involves many people and aims to confirm if the drug is both safe and effective enough to be considered for wider use. Participants will be closely monitored, and their progress will be carefully compared between those receiving the new drug and those receiving the placebo, all while ensuring their well-being.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Xenon Pharmaceuticals Inc.

Enrolment target

168

Start

19 Apr 2023

Focal Onset Seizures

What is this study about?

This study is about understanding how a new medicine, called XEN1101, could help people who have a type of epilepsy called focal-onset seizures. These seizures start in a specific area of the brain. The study wants to find out if taking XEN1101, alongside their usual treatment, can reduce how often these seizures happen.

To do this, some people in the study will get the new medicine, and others will get a 'dummy' pill (called a placebo). This is done so researchers can fairly compare if the new medicine is actually making a difference. Neither you nor your doctor will know if you're getting the active drug or the placebo, which helps make the results as accurate as possible. Everything will be carefully monitored to see how safe XEN1101 is and if it helps reduce seizures.

This kind of study is a 'Phase 3' trial. This means it's one of the final steps before a new medicine can be considered for approval. It involves many people and aims to confirm that the medicine is safe and works well enough to help improve the lives of people living with focal-onset seizures.

Key takeaways

This study is testing a new medicine, XEN1101, for focal-onset seizures.
It aims to see if the medicine can reduce the number of seizures by half or more.
Some participants will receive the new medicine, others a dummy pill (placebo).
It's open to adults aged 18 and over who have focal-onset seizures.
Participation involves regular clinic visits and tracking your seizures.
Taking part is voluntary, and you can withdraw at any time.

Who may be eligible?

This study is looking for adults aged 18 years and older who have focal-onset seizures. Both men and women are welcome to take part.

There might be other specific health requirements or conditions that would mean you can or cannot join the study. These are put in place to ensure your safety and to make sure the study results are clear and helpful for future patients. For example, certain other medical conditions or medicines you take might mean you can't participate.

If you're interested in taking part, the study team will ask you some questions about your health and medical history to check if the study is suitable for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have focal-onset seizures?
Are you currently taking medication for your seizures?
Are you able to attend regular clinic appointments?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be given either the new medicine, XEN1101, or a placebo (dummy pill) in capsule form. You'll take this alongside your current epilepsy medication. Throughout the study, you'll have regular visits to the clinic so the study team can monitor your health, how often your seizures happen, and if you experience any side effects. You'll likely be asked to keep a diary of your seizures and any other symptoms.

The main part of testing how well the drug works will involve tracking your seizures over 28-day periods. We'll be particularly interested in whether the number of seizures you have goes down by at least half. The total duration of your participation in the study, including follow-up, will be explained in detail by the study team.

Potential risks and benefits

Taking part in a study like this could potentially offer you access to a new treatment before it's widely available, which might help reduce your seizures. However, there's no guarantee the new medicine will work for you, or that you'll even receive the active medicine rather than the placebo. Like all medicines, XEN1101 could have side effects, and some might be serious, even if they are rare. The study team will explain all known risks. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (9)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Spain
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Unverified
Poland
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Unverified
Bulgaria
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Unverified
Italy
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Unverified
Germany
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Unverified
Ireland
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Unverified
Czechia
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Unverified
Latvia
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Unverified
Portugal

Common questions

What are focal-onset seizures?

Focal-onset seizures are a type of seizure that begins in one specific area of the brain.

What is a placebo?

A placebo is a 'dummy' pill that looks like the study drug but contains no active medicine. It's used to compare the real drug's effects.

What does 'double-blind' mean?

It means neither you nor your doctor will know if you're receiving the actual medicine or the placebo, which helps make the results more reliable.

Will I still take my regular seizure medicine?

Yes, this study is designed for XEN1101 to be taken alongside your current epilepsy medication.

What is the main goal of this study?

The main goal is to see if XEN1101 can reduce the number of focal seizures people have by at least 50% each month.