Study on Etrinabdione for Patients with Peripheral Arterial Disease: Evaluating Safety and Tolerability

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What is this study about?

This clinical trial is focused on studying a condition known as Peripheral Arterial Disease (PAD), which affects blood circulation in the legs. The trial will test a new medication called Etrinabdione, also known by its code names EHP-101 and VCE-004.8. Etrinabdione is provided as an oral solution, meaning it is taken by mouth in liquid form. The purpose of the study is to evaluate the safety and tolerability of Etrinabdione in patients with PAD.

Participants in the study will receive Etrinabdione for up to 12 months. Throughout the study, researchers will monitor the incidence and severity of any treatment-related side effects. Additionally, they will observe changes in various health indicators, such as blood flow in the legs, using methods like Angio-CT and Doppler ultrasound. The study will also assess improvements in quality of life and measure levels of Etrinabdione in the blood at different times.

The trial aims to gather preliminary information on how well Etrinabdione works in improving symptoms of PAD, such as leg pain during walking, known as claudication. By the end of the study, researchers hope to better understand the potential benefits and risks of using Etrinabdione for treating PAD.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, health condition, and ability to comply with the study protocol.

Participants must provide informed consent, indicating their understanding and agreement to participate in the study.

2 initial assessment

An initial assessment is conducted to establish baseline health metrics. This includes evaluating vascular health, hemodynamic status, and quality of life.

Tests may include Angio-CT, ankle/brachial index, doppler ultrasound, and transcutaneous oximetry (TcPO2).

3 medication administration

Participants begin taking the Etrinabdione oral solution as prescribed. The medication is administered orally.

The treatment period can last up to 12 months, with regular monitoring of health and medication levels.

4 regular monitoring

Throughout the study, regular check-ups are scheduled to monitor the participant’s health and the effects of the medication.

Blood tests are conducted to measure Etrinabdione plasma levels at specific intervals: Day 1, and months 1, 3, 6, and 12.

5 evaluation of outcomes

The study evaluates the incidence and severity of any adverse effects that may occur during the treatment.

Secondary outcomes include changes in vascularization, hemodynamic status, stenosis, quality of life, tissue oxygenation, and clinical improvement.

6 end of study

At the end of the study, a final assessment is conducted to evaluate the overall impact of the treatment.

Participants are informed of the study’s findings and any implications for their health.

Who Can Join the Study?

Men and women who are between the ages of 50 and 85.
Must be willing and able to give their agreement to participate and understand the study details.
Must have a condition called critical limb ischemia (CLI), which is a severe blockage in the arteries of the legs, causing pain or wounds. This is classified as Rutherford Category 2 or 3, meaning moderate or severe pain when walking.
Must have type 2 diabetes, a condition where the body has trouble using sugar properly.
Must have a glycosylated hemoglobin (HbA1c) level of less than 9%. This is a blood test that shows average blood sugar levels over the past 2 to 3 months.
If receiving treatment for Peripheral Arterial Disease (PAD), the condition must be managed with appropriate medical therapy for CLI, unless there is a documented reason why this treatment cannot be used or is not tolerated.
Women can participate if they are not pregnant or breastfeeding and meet one of the following conditions:
- Not able to have children, either due to surgery (like removal of the uterus or ovaries) or being postmenopausal (no periods for 12 months for reasons other than medical conditions).
- If able to have children, must agree to use a highly effective birth control method during the study and for at least 28 days after the last dose of the study treatment.
Men with female partners who can have children must agree to use acceptable birth control during the study and for about 90 days after the last dose of the study treatment. They must also agree not to donate sperm during this time.

Who Cannot Join the Study?

Where you can join this trial?

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Trial status

Country	Status	Recruitment Start
Spain	Not recruiting	01.06.2024

Trial locations

Investigated drugs:

Etrinabdione

Etrinabdione is being studied for its safety and how well patients can tolerate it. This medication is being tested in people who have Peripheral Arterial Disease (PAD). The trial aims to see if Etrinabdione can be used safely over a period of up to 12 months and to gather early information on how effective it might be in treating PAD.

Peripheral Arterial Disease – This condition involves the narrowing of blood vessels outside of the heart, primarily affecting the arteries that supply blood to the legs and feet. It is often caused by atherosclerosis, where fatty deposits build up on the artery walls, leading to reduced blood flow. As the disease progresses, individuals may experience symptoms such as leg pain or cramping during physical activities like walking or climbing stairs, which typically eases with rest. Over time, the reduced blood flow can lead to more severe symptoms, including persistent pain, wounds that do not heal, or even gangrene. The progression of the disease can significantly impact mobility and quality of life. Regular monitoring and lifestyle changes are crucial in managing the condition.

Trial ID:

2023-509452-34-00

Protocol code:

2023-509452-34-00

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Etrinabdione for Patients with Peripheral Arterial Disease: Evaluating Safety and Tolerability

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