AuthorisedTherapeutic exploratory (Phase II)Interventional

RENAISSANCE 2: A Double-Blind, Randomized, Placebo-Controlled, Multicenter, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of SPN-817 in Adults with Focal Onset Seizures

The RENAISSANCE 2 study is looking into a new medication called SPN-817 for adults who experience focal onset seizures. These are seizures that start in one part of the brain. The main goal is to find out if this new medicine can reduce the number of seizures people have and if it's safe to use. Participants will be randomly given either the new medicine or a dummy medicine (a placebo) that looks the same but contains no active drug. This helps researchers fairly compare how well the new medicine works. The study will also check other things like how the medicine affects a person's quality of life and how often side effects occur.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Supernus Pharmaceuticals Inc.

Enrolment target

Start

20 Oct 2025

Focal Onset Seizures

What is this study about?

This study, called RENAISSANCE 2, is looking into a new medicine called SPN-817. It's for adults who have a specific type of seizure called focal onset seizures. These seizures start in one area of the brain. The researchers want to discover if this new medicine can help reduce how often these seizures happen and if it's safe to use. This kind of study is an important step in developing new treatments.

To make sure we get clear answers, some participants will receive the new medicine, while others will get a 'dummy' medicine, called a placebo. A placebo looks exactly like the real medicine but has no active ingredients. Neither the participants nor their doctors will know who is getting which, which helps ensure the results are unbiased. This is a common and important way to test new treatments.

Understanding how a new medicine works and if it has any side effects is crucial. The study will carefully track changes in seizure frequency, but also look at other important aspects like overall well-being, quality of life, and any discomfort or side effects people might experience.

Key takeaways

This study tests a new medicine (SPN-817) for focal onset seizures.
It aims to see if the medicine reduces seizures and is safe.
You might receive the new medicine or a dummy medicine (placebo).
Regular clinic visits, tests, and questionnaires are part of the study.
Both men and women aged 18 and over can potentially take part.
You can stop participating at any time without affecting your care.

Who may be eligible?

This study is looking for adults aged 18 and over who experience focal onset seizures. Both men and women can take part.

Specific medical conditions or medications you are currently taking might affect whether you can join, as could certain health measurements like your blood test results or heart readings. These details are checked carefully by the study team to make sure it's safe for you to participate.

Quick self-check

Are you 18 years old or older?
Do you have focal onset seizures?
Are you able to attend regular clinic appointments?
Are you willing to take study medication as instructed?
Are you comfortable having regular health checks like blood tests and ECGs?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join the study, you'll be part of it for a set period. You'll have regular visits to the clinic where doctors and nurses will monitor your health and how the medicine is affecting you. You'll take the study medicine (either SPN-817 or the dummy medicine) regularly as instructed. This will involve taking capsules.

During your visits, you'll have various assessments including physical exams, blood tests, heart checks (ECGs), and discussions about your seizures, how you're feeling, and any side effects. You'll also complete questionnaires about your quality of life. The study involves an initial period where the dose of the medicine might be gradually increased, followed by a longer period where you'll be on a stable dose. After you stop taking the study medicine, there will be follow-up checks to make sure everything is okay. The total duration of your involvement will be clearly explained by the study team.

Potential risks and benefits

Taking part in a study like this might have potential benefits, such as receiving a new medicine that could help reduce your seizures, and contributing to medical knowledge that benefits others. However, there's no guarantee the new medicine will work for you, and you might receive the dummy medicine. Potential risks include experiencing side effects from the medicine, which will be carefully monitored. There's also the time commitment for appointments and tests. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

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Poland
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Hungary
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Bulgaria

Common questions

What is a focal onset seizure?

A focal onset seizure is a seizure that starts in just one particular area of your brain.

What does 'double-blind' mean?

It means neither you nor your doctor will know if you're getting the active medicine or the dummy medicine (placebo). This helps keep the study fair.

What is a 'placebo'?

A placebo is a 'dummy' medicine that looks like the real thing but doesn't contain any active drug. It's used to compare against the new medicine.

Will I have to have many tests?

Yes, you will have regular medical checks, blood tests, and heart tests (ECGs) to monitor your health and the medicine's effects.

Can I stop participating if I want to?

Yes, you can leave the study at any time, and you don't need to give a reason. Your standard care won't be affected.