CompletedPhase IIInterventional

ReMEdi - Randomised controlled trial of the safety and efficacy of PHOE-01 in ME/CFS with digital monitoring

The ReMEdi study is a medical trial looking into a potential new treatment called PHOE-01 for people with Myalgic Encephalomyelitis, also known as ME/CFS. This condition can cause long-lasting tiredness, pain, and other symptoms. The study aims to find out if PHOE-01 is safe to use and if it helps to improve symptoms. Participants will be monitored using digital devices, which could include things like smartwatches or apps, to track their health and progress. The study is currently in Phase II, meaning it's still in the earlier stages of testing. Full details about how the study works, including what participants will experience, will be made public by January 24, 2026.

At a glance

Status

Completed

Phase

Phase II

Sponsor

Alfred E. Tiefenbacher (Germany)

Enrolment target

Start

05 Feb 2025

Estimated completion

08 Jan 2026

Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

What is this study about?

This study, called ReMEdi, is a type of research called a "randomised controlled trial." This is considered the best way to test new treatments because it helps researchers understand if the new treatment really works better than existing care or a dummy treatment. In this specific trial, doctors are investigating a new treatment called PHOE-01 for Myalgic Encephalomyelitis, or ME/CFS.

ME/CFS is a long-term condition that can cause extreme tiredness, which doesn't get better with rest, and can get worse after even small amounts of activity. People with ME/CFS can also experience pain, sleep problems, and difficulty thinking clearly. Finding effective treatments for ME/CFS is very important, and studies like ReMEdi aim to discover new ways to help improve the lives of those affected.

The study will also use digital monitoring, which means participants might use devices like activity trackers or smartphone apps to help doctors keep an eye on their health and how they are responding to the treatment. This can provide valuable information about how people feel and function in their daily lives. The goal is to see if PHOE-01 is safe to use and if it can effectively reduce the symptoms of ME/CFS.

Key takeaways

The ReMEdi study is testing a new treatment called PHOE-01 for ME/CFS.
It aims to see if PHOE-01 is safe and helps improve symptoms.
The study uses digital tools to monitor participants' health.
Full details about how the study works will be released by January 2026.
Participants must be between 18 and 60 years old.

Who may be eligible?

Currently, the full details about who can and cannot join this specific study are not available to the public. This sometimes happens in research, as medical ethics committees need to check and approve all the study plans.

However, we do know that participants must be between 18 and 60 years old. Both men and women will be able to take part. Specific details about the ME/CFS diagnosis required, any other health conditions that might prevent participation, or medications that might not be allowed during the study will be shared later.

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 between 18 and 60 years old?
Do you have a diagnosis of Myalgic Encephalomyelitis (ME/CFS)?
Are you prepared for digital monitoring (e.g., using an app or device)?
Are you able to commit to the study for its full duration (to be announced)?
Are you based in the UK, where the study is likely taking place?

Answer every question to see your result.

What does participation involve?

At the moment, we do not have all the specific details about what taking part in the ReMEdi study will involve. This information is being kept private for now, but will be shared by January 24, 2026.

Typically, joining a clinical trial might involve regular visits to a clinic for check-ups and tests, such as blood tests or physical examinations. You would also receive the study medication (PHOE-01 or a comparison treatment) and follow instructions on how to use it. Digital monitoring would involve using certain devices or apps to track your health and symptoms over time. There would also be follow-up appointments and assessments to see how you are doing, and the whole study would last for a specific period, which will be announced later.

Potential risks and benefits

Taking part in any clinical trial has potential benefits and risks. A potential benefit of joining this study is that you might have access to a new treatment for ME/CFS (PHOE-01) before it's widely available. You would also contribute to understanding ME/CFS and finding better treatments for others. Potential risks include side effects from the medication, which would be explained in full once the study details are released. There's also no guarantee that the treatment will work for you. Remember, you have the right 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.

Lindus Health
City only
London, England

Common questions

What is ME/CFS?

ME/CFS stands for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome. It's a long-term illness that causes extreme tiredness, pain, and other symptoms that can make everyday life very difficult.

What is PHOE-01?

PHOE-01 is the name of the new treatment being tested in this study. Researchers are investigating if it is safe and effective for people with ME/CFS.

What does 'Phase II' mean?

Phase II means the new treatment is in an earlier stage of testing. It's designed to see if the treatment works and to find the right dosage, after it's been shown to be safe in a smaller group (Phase I).

Why aren't all the study details available yet?

Sometimes, the full details of a study are kept private for a short time to protect the privacy of the participants or the research plan. All the information will be made public by January 2026.

Will I get paid to take part?

The information about whether participants will be reimbursed for their time or travel is not yet available, but it's a good question to ask when more details are released.

How to find out more

Trial Lead

remedi@lindushealth.com +44 800 086 8449 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.