Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Phase IIa Open Label, Dose-Finding, Clinical Trial to Evaluate Safety, Tolerability and Preliminary Efficacy of Etrinabdione in Patients with Peripheral Arterial Disease (PAD). CLAUDIA Trial

The CLAUDIA study is an early-stage clinical trial looking into a new oral medicine called Etrinabdione for people with Peripheral Arterial Disease (PAD). PAD is a common condition where narrowed arteries reduce blood flow to your limbs, most commonly your legs, often causing pain when walking. This study aims to find out the safest and most effective dose of Etrinabdione. Researchers will carefully monitor participants for any side effects and see how well the medicine is tolerated. They will also look for early signs of whether Etrinabdione can improve blood flow, reduce leg pain, and improve overall quality of life for people living with PAD. This will help them understand if the medicine should be tested in larger studies.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Vivacell Biotechnology Espana S.L.

Enrolment target

Start

13 May 2024

Peripheral Arterial Disease

What is this study about?

The CLAUDIA trial is an important early-stage study (Phase IIa) designed to learn more about a new medicine called Etrinabdione. This medicine is being developed to help people who have Peripheral Arterial Disease, often shortened to PAD. PAD happens when the arteries, which are the blood vessels carrying blood from your heart to your limbs, become narrowed. This can reduce blood flow, especially to your legs, leading to symptoms like pain or cramping, particularly when you walk.

In this study, researchers are giving different doses of Etrinabdione as a liquid medicine by mouth. The main goal is to understand how safe this new medicine is and if people can tolerate it without too many uncomfortable side effects. They will be carefully watching for any new or worsening health problems that might happen during the study.

Beyond safety, the study also wants to see if Etrinabdione shows any early promise in improving PAD. This means they will be checking things like blood flow in the legs, using special scans and measurements. They'll also ask participants about their leg pain, how far they can walk, and how their overall quality of life is affected. By gathering all this information, the study hopes to find the best dose and decide if Etrinabdione is a good candidate for further testing in larger groups of people with PAD.

Key takeaways

This study (CLAUDIA) is for people with Peripheral Arterial Disease (PAD).
It's testing a new oral medicine called Etrinabdione.
The main goals are to check the medicine's safety, how well people tolerate it, and if it shows early signs of improving PAD.
It's an early-stage (Phase IIa) trial, helping researchers decide on future steps for this medicine.
Participants will have regular check-ups and various tests to monitor their health and PAD symptoms.

Who may be eligible?

To join the CLAUDIA study, you need to be at least 18 years old. There's no upper age limit, meaning older adults can also take part. The study is open to both men and women.

The most important requirement is that you must have Peripheral Arterial Disease (PAD). This is a condition where your arteries, especially in your legs, become narrowed, reducing blood flow. Your doctor will be able to confirm if you have this condition based on specific tests and your medical history.

There will be other specific health requirements that your study doctor will discuss with you. These are put in place to ensure your safety and that the study results are as clear and accurate as possible. It’s important to remember that even if you meet the main age and PAD criteria, further medical checks will be needed to see if you can safely participate.

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?
Have you been diagnosed with Peripheral Arterial Disease (PAD)?
Are you willing to take a new oral liquid medicine?
Are you able to attend regular clinic visits for medical checks and tests?
Are you comfortable having various scans and blood tests?
Are you open to discussing your symptoms and quality of life with study staff?

Answer every question to see your result.

What does participation involve?

If you decide to take part in the CLAUDIA study, you would be taking the new medicine, Etrinabdione, as an oral liquid. You would have several visits to the study clinic throughout the trial. These visits would involve various checks and tests. For example, the study team would regularly check your overall health and look for any side effects. They might also take blood samples to measure the level of the medicine in your body and check for certain markers related to your condition.

You would also undergo specific tests to assess your PAD. These could include ultrasound scans of your legs to look at blood vessels, measurements of your blood pressure in your ankles and arms, and possibly CT scans to get detailed images of your arteries. You would also be asked to complete questionnaires about your quality of life and how your leg pain affects you, especially when walking. The total duration of your involvement in the study, including follow-up, would be decided by the study design, and the research team will explain this to you fully before you commit.

Potential risks and benefits

Taking part in any clinical study comes with potential benefits and risks. A potential benefit of joining this study is that you would receive a new medicine under close medical supervision for your PAD, which might improve your symptoms or condition. However, it's important to remember that Etrinabdione is still in an early stage of testing, so we don't yet know for sure how effective it will be. As with all medicines, there is a risk of side effects, which could be mild or more serious, and researchers will be closely monitoring you for these. You will be fully informed of all known potential risks before you consent to participate. It's your right to choose to withdraw from 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.

—
Unverified
Spain

Common questions

What is Peripheral Arterial Disease (PAD)?

PAD is when narrowed or blocked arteries (blood vessels) reduce blood flow to your limbs, most commonly your legs. This can cause pain when walking or other symptoms.

What is Etrinabdione?

Etrinabdione is a new medicine being tested as a liquid you take by mouth. Researchers hope it might help improve blood flow for people with PAD.

What does 'Phase IIa' mean?

Phase IIa means it's an early-stage study focusing on finding the right dose and checking how safe the medicine is, as well as looking for early signs it might work.

Will this study cure my PAD?

This is an early study, so it's designed to learn more about the medicine's safety and early effects, not necessarily to find a cure. It will help determine if further, larger studies are warranted.

How long will I be in the study?

The exact duration will vary, but studies like this usually involve several months to a year or more of active participation and follow-up. The study team will provide you with the specific timeline.