AuthorisedHuman Pharmacology (Phase I)- OtherInterventional

A randomized, multiple ascending doses, clinical trial to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics of CV-01 after double-blind, placebo-controlled multiple oral administrations for 2 weeks in healthy volunteers, and multiple oral administrations open-label for 2 weeks in a cohort of participants with drug resistant epilepsy

This early-stage medical study, called a Phase 1 trial, is looking into a new potential medicine named CV-01. The main goal is to see if CV-01 is safe to use and how well people can tolerate it. Researchers also want to understand how the medicine works in the body and how it is processed. The study will first involve healthy volunteers who will take the medicine (or a dummy pill) for two weeks. After that, a small group of people who have epilepsy that hasn't improved with other treatments (drug-resistant epilepsy) will take CV-01 for two weeks. This research is crucial for understanding new treatments and developing better ways to help people with epilepsy.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Angelini Pharma Italia Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A. Enunciabile Anche Angelini Pharma Italia S.p.A. Angelini Pharma S.p.A. A.C.R.A.F. S.p.A. Acraf S.p.A. Angelini S.p.A. aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A.

Enrolment target

Start

08 Jun 2026

Drug resistant epilepsy

What is this study about?

This study is a very early step in trying to find new ways to treat epilepsy, especially for people whose seizures are not controlled by existing medicines. The new medicine being tested is called CV-01. At this stage, called a Phase 1 study, the main focus is on safety. Before a new medicine can be used widely, doctors need to be sure it doesn't cause serious harm.

Researchers will be giving different doses of CV-01 to see how the body reacts. They will carefully watch for any side effects and learn how much of the medicine the body can handle. They will also look at how the medicine is absorbed, what it does inside the body, and how it is removed. This information is really important because it helps scientists decide if the medicine is promising enough to continue testing in larger groups of people.

This trial is split into two main parts. First, healthy volunteers will take the medicine. This helps researchers understand its basic effects without other health conditions getting in the way. After that, a small group of people who have drug-resistant epilepsy will take CV-01. This is the first time the medicine will be given to people who actually have the condition it's designed to treat. The findings from this study will guide future research into CV-01 and hopefully lead to new treatment options for epilepsy.

Key takeaways

This is an early-stage study (Phase 1) of a new medicine for epilepsy.
The main focus is to check if the medicine (CV-01) is safe and well-tolerated.
It first involves healthy volunteers, then a small group with drug-resistant epilepsy.
Participants take the medicine by mouth for two weeks.
Both men and women aged 18 and over can potentially take part.
Your participation helps advance understanding of new epilepsy treatments.

Who may be eligible?

To join any medical study, there are certain rules about who can take part. These rules are in place to make sure the study is safe for everyone involved and that the results are clear and reliable.

For this particular study, participants must be at least 18 years old. Both men and women can join. There are likely other specific health checks and requirements not fully described here, which ensure you are suitable for the study and that it's safe for you.

If you have drug-resistant epilepsy and are interested in the study, a doctor or nurse involved in the research would need to review your full medical history and current health to determine if this study is right for you. They will explain all the requirements in detail.

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 at least 18 years old?
Do you have epilepsy that hasn't responded to other treatments (if applying for the second part)?
Are you able to attend regular clinic visits?
Are you willing to take the study medicine for two weeks?
Are you comfortable with regular health checks, including blood tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would first have a full check-up to make sure you're suitable. Once enrolled, you would receive either the new medicine, CV-01, or a 'dummy' pill (placebo) if you're a healthy volunteer, or CV-01 if you have drug-resistant epilepsy. You would take this medicine by mouth for two weeks.

During these two weeks, and possibly for a period before and after, you would need to attend regular appointments at the study clinic. These visits would involve doctors and nurses checking your health, asking about any side effects, and possibly taking blood or urine samples. They might also do other tests to see how the medicine is affecting your body. The total amount of time you would be involved in the study, including all visits and follow-ups, would be explained to you before you agree to participate.

Potential risks and benefits

Taking part in a study like this might offer a chance to try a new medicine that could potentially help your condition, especially if other treatments haven't worked well. You would also be contributing to medical science, which helps everyone. However, there are potential risks, as with any new medicine. You might experience side effects that are unknown or unexpected. The medicine might not help your condition, or it might not work as well as hoped. You are always free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

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Unverified
Sweden

Common questions

What is 'drug-resistant epilepsy'?

This means your epilepsy hasn't responded well to at least two different anti-seizure medicines, meaning you still have seizures despite treatment.

Who is funding this study?

The information above does not specify the funder, but this would be explained to you in detail if you consider joining the study.

Will I know if I'm getting the real medicine or a dummy pill?

In the healthy volunteer part, it's 'double-blind,' meaning neither you nor the research team will know. In the epilepsy part, it's 'open-label,' meaning both you and the team will know you are receiving CV-01.

How long will I be taking the study medicine?

Participants will be taking the study medicine for two weeks.

What is a 'Phase 1' study?

Phase 1 is the earliest stage of human testing for a new medicine. It mainly focuses on checking if the medicine is safe and what doses are tolerated, often starting with a small number of people.