Active not recruitingPHASE2INTERVENTIONAL

A Study to Evaluate XEN1101 as Adjunctive Therapy in Focal Epilepsy

This research study is looking into a new medicine called XEN1101 for adults aged 18 to 75 who have focal epilepsy. The main goal is to find out if XEN1101 can help reduce the number of seizures when taken alongside their usual epilepsy medicines. The study will also check how safe the medicine is and if people experience any side effects. Participants will be randomly given either XEN1101 at different doses or a dummy medicine (placebo). There's also an option to continue with XEN1101 after the main study ends. This is a "Phase 2" trial, which means it's an important step in understanding new treatments.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Xenon Pharmaceuticals Inc.

Enrolment target

325

Start

30 Jan 2019

Estimated completion

01 Oct 2028

Focal Epilepsy

What is this study about?

This study is investigating a new medication called XEN1101 for people who experience focal epilepsy. Focal epilepsy means that seizures start in one particular part of the brain. The study wants to find out if XEN1101 can help reduce the number of seizures people have when it's taken in addition to their current epilepsy medicines. It will also help researchers understand if XEN1101 is safe and well-tolerated by patients.

This is a "Phase 2" clinical trial, which means it's an important step in the long process of developing new medicines. In this phase, researchers are trying to learn more about the medicine's effects, find the right dose, and check for any common side effects in a larger group of people than in earlier studies.

Participants in this study will be randomly assigned to receive either one of three different doses of XEN1101 or a placebo (a dummy pill that looks like the medicine but contains no active drug). This helps to ensure the results are fair and reliable. The study also includes an optional extension period where all participants will receive XEN1101, allowing researchers to gather more long-term information.

Key takeaways

It's a study testing a new medicine (XEN1101) for focal epilepsy.
Aimed at adults (18-75 years) taking other epilepsy medications.
Compares XEN1101 to a dummy pill (placebo) to see if it reduces seizures.
Involves tracking seizures and attending study visits for about 5.5 months (main study).
There's an optional longer-term period where everyone gets XEN1101.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, you need to be an adult between 18 and 75 years old and have been diagnosed with focal epilepsy for at least two years. You must also be taking one to three other epilepsy medicines at a steady dose for at least one month before the study starts and throughout the main part of the study.

There are also some general health requirements, like having a healthy weight (BMI of 40 or less) and not having any major medical conditions that could make taking part unsafe. You'll also need to be able to keep a record of your seizures.

Some things that would mean you can't join include having certain other types of seizures or conditions like Lennox-Gastaut syndrome, or if your seizures are caused by another disease. If you've had certain brain surgeries recently, or have had serious mental health issues like an active plan to harm yourself in the last six months, you also wouldn't be able to take part.

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 between 18 and 75 years old?
Do you have focal epilepsy and have you been diagnosed for at least 2 years?
Are you currently taking 1 to 3 stable anti-epilepsy medicines?
Can you commit to recording your seizures regularly?
Do you have good general health and no other major medical conditions that would prevent participation?
Are you willing to discuss and follow contraception requirements during the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first have a screening visit to check if you're suitable. After that, you'll spend 8 weeks quietly recording your usual number of seizures; this helps us understand your seizure frequency before any new treatment. Then, for another 8 weeks, you'll take the study medicine or placebo once daily in the evening, alongside your existing epilepsy medication.

During this time, you'll need to keep careful track of your seizures in a diary. After the 8 weeks of treatment, there will be a 6-week follow-up period. The total duration for the main part of the study, including screening, baseline, treatment, and follow-up, will be around 22 weeks (about 5 and a half months).

If you complete the main study and are eligible, you'll have the option to continue into an 'open-label extension'. In this part, everyone will receive XEN1101 at a 20 mg dose daily, and this period can last longer.

Potential risks and benefits

Taking part in a clinical trial always involves a balance of potential benefits and risks. You might benefit if XEN1101 helps reduce your seizures or if you gain a better understanding of your condition through the close medical monitoring. However, there's no guarantee the medicine will work for you, and you might receive the placebo. Possible risks could include side effects from XEN1101, which are not yet fully known, or effects from interacting with your current medications. There's also the inconvenience of study visits and recording information. Remember, participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (95)

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

University of Alabama at Birmingham
Verified postcode
Birmingham, United States
Strada Patient Care Center
Verified postcode
Mobile, United States
Xenoscience, Inc.
Verified postcode
Phoenix, United States
Clinical Trials, Inc.
Verified postcode
Little Rock, United States
Altman Clinical Translational Research Institute (ACTRI)
Verified postcode
La Jolla, United States
California Pacific Medical Center (CPMC) - Sutter Pacific Epilepsy Program
Verified postcode
San Francisco, United States
University of Colorado Hospital Anschutz Outpatient Pavilion
Verified postcode
Aurora, United States
University of Florida Jacksonville
Verified postcode
Jacksonville, United States
Mayo Clinic Florida
Verified postcode
Jacksonville, United States
Visionary Investigators Network
Verified postcode
Miami, United States
Don Clinical Research Center
Verified postcode
Miami, United States
The Neurology Research Group, LLC.
Verified postcode
Miami, United States

Common questions

What is focal epilepsy?

Focal epilepsy is a type of epilepsy where seizures start in a specific part of your brain, rather than affecting your whole brain at once.

What does 'adjunctive therapy' mean?

Adjunctive therapy means that this new medicine, XEN1101, would be taken in addition to the epilepsy medicines you are already using, not as a replacement for them.

What is a 'placebo'?

A placebo is a dummy pill that looks exactly like the study medicine but doesn't contain any active drug. It helps researchers compare the real effects of the medicine.

Will I know if I'm getting XEN1101 or the placebo?

No, during the main part of the study, neither you nor your doctor will know if you are receiving XEN1101 or the placebo. This is called 'double-blind'.

Can I stop taking my current epilepsy medicine if I join the study?

No, you must continue taking your current epilepsy medicines at a steady dose throughout the main part of the study. XEN1101 is designed to be taken alongside them.