Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Randomized Phase 2 Study of Adjunctive EQU-001 for Uncontrolled Focal Onset Seizures

This research study is looking into a new medication called EQU-001. It's designed for adults with a type of epilepsy called focal onset seizures, where existing treatments haven't fully stopped their seizures. The main goal is to find out if EQU-001 can help reduce the number of seizures a person has over a 28-day period, compared to a placebo (a dummy pill with no active drug). Researchers will also look at how many people have their seizures cut in half, how the medicine affects their quality of life, and any side effects. This is a mid-stage study to learn more about the medicine's effectiveness and safety.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Equilibre Biopharmaceuticals B.V.

Enrolment target

123

Start

01 Feb 2023

Epilepsy

What is this study about?

This study, called a Phase 2 trial, is testing a new medicine for epilepsy called EQU-001. It's for adults whose focal onset seizures (seizures that start in one part of the brain) are not well controlled with their current medications. The main purpose of this research is to see if EQU-001 can help reduce the number of seizures someone experiences. Participants will be given either the new medicine or a placebo, which looks identical but contains no active drug, to fairly compare the effects.

Throughout the study, doctors will closely monitor how many seizures participants have. They will primarily look at the percentage change in the number of observable seizures over a 28-day period. This helps them understand whether the new medicine is having a real effect. They will also be looking at other important aspects, like how many people have a significant reduction (50% or more) in their seizures, how the medicine might affect a person's quality of life, and if there are any specific types of seizures that respond better.

The findings from this study are very important. If EQU-001 shows promise in safely reducing seizures, it could potentially become a new treatment option for people living with epilepsy. This type of research helps doctors and scientists understand how new medicines work, whether they are safe, and if they could improve the lives of patients.

Key takeaways

This study tests a new epilepsy medicine, EQU-001, for uncontrolled focal onset seizures.
It aims to see if EQU-001 can reduce seizure frequency compared to a dummy pill (placebo).
You will be randomly assigned to receive either EQU-001 or the placebo, without knowing which one.
The study also looks at how the medicine affects quality of life and any side effects.
Participation involves regular clinic visits and close monitoring by the study team.

Who may be eligible?

To join this study, you must be at least 18 years old. Both men and women can take part.

More specific details about your type of epilepsy, your current medications, and other health conditions will be checked by the study team to make sure this trial is the right fit for you. This is to ensure your safety and that the study results are clear.

If you are interested, the study doctors will go through a detailed checklist with you to see if you meet all the requirements for taking 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 18 years old or older?
Do you have focal onset seizures that are not fully controlled by your current medications?
Are you able and willing to attend regular clinic appointments?
Are you willing to potentially receive either the new medicine or a placebo?

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 are suitable. If you are, you'll be assigned by chance to either receive the new medicine EQU-001 or a placebo (a dummy pill). You won't know which one you're getting, and neither will your study doctor, until the study is over. This is called a 'double-blind' approach and helps ensure the results are unbiased.

You will take the study medication regularly. Over several weeks and months, you will have regular visits to the clinic where the study team will check your health, ask about your seizures, and monitor for any side effects. This will involve physical examinations and possibly blood tests.

The study will last for a number of weeks, with different phases for taking the medication and follow-up assessments. The total duration of your participation will be explained in detail by the study team.

Potential risks and benefits

Taking part in any study has potential benefits and risks. You might benefit from the new medicine if it reduces your seizures, or you might gain valuable information about your condition and receive careful medical attention. However, there's always a chance the medicine may not help you, or you could experience side effects. It's important to remember that you can stop taking part in the study at any time, for any reason, without it affecting your usual medical care.

Locations (8)

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

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Unverified
Sweden
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Unverified
Italy
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Unverified
France
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Unverified
Spain
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Unverified
Netherlands
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Unverified
Czechia
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Unverified
Lithuania
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Unverified
Poland

Common questions

What is a 'Phase 2' study?

Phase 2 studies are early-stage trials that test if a new medicine works for a specific condition and to find out more about its safety and best dosage.

What are 'focal onset seizures'?

These are seizures that begin in one specific part of the brain. They can affect people in different ways, depending on where they start.

What is a placebo?

A placebo is a dummy pill that looks exactly like the real medicine but contains no active drug. It helps researchers fairly compare the effects of the new medicine.

Will I know if I'm getting the real medicine or the placebo?

No, you and your study doctor won't know until the study is over. This is called a 'double-blind' study and helps make the results more reliable.

What happens if I experience side effects?

The study team will closely monitor you for any side effects and will be available to answer your questions and address any concerns you have throughout the study.