Open ReMEdi clinical trial, UK [Lindus Health, Alfred E. Tiefenbacher GmbH]

InitialConditions

InitialConditions

Senior Member (Voting Rights)
Myalgic encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) affects around 1% of the population, bringing significant challenges to daily life. There is an urgent need for new, effective treatments to improve the quality of life for those affected.

If you've been living with ME/CFS symptoms for at least 6 months, we invite you to participate in this important trial testing a possible new treatment.

During the trial, you will receive both the trial medication and a placebo, which looks like real medicine but has no active ingredients. During the trial, you will take both the trial medication and the placebo, for 2 weeks each. You will be randomly assigned to receive either the active treatment or the placebo first. Neither you nor the trial team will know your assignment.

The trial participation will take a total of 9 weeks and all in the comfort of your own home.

Participants will receive compensation up to £200.

Please contact us at remedi@lindushealth.com if you have any questions.

Your involvement could help pave the way for new, targeted treatments.

https://www.lindushealth.com/research/living-better-with-me-cfs
 
●
PHOE-01 is the trial medication being investigated in this trial, we will refer to
PHOE-01 as the “trial medication”.
●
The aim of the trial is to see if the trial medication can help improve your quality of
life by using a fatigue questionnaire (MFI-20) and a Functional Capacity questionnaire
(FUNCAP-27) to see how you feel before and after taking the medication or a
placebo.
●
We plan to enrol 25 participants in this trial.
●
Trial participation is expected to last around 9 weeks.
●
The trial is fully remote; surveys and daily diaries are completed online and trial
assessments are completed at home. Trial medication will be posted to your home
address. We will also ask a nurse to visit your home to collect blood for a blood test.
●
The trial involves video/phone calls which can be split into parts or rescheduled
based on your needs.
●
Taking part is voluntary, and you are free to withdraw from the trial at any time
●
A decision not to take part will not affect the standard of care in any way, now or in
the future.
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Even though it’s remote — they aren’t accepting severe people
 
forestglip said:
Is there not a legal requirement to tell participants what drug they will be taking?
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There is a legal requirement to obtain informed consent and that requires adequate information. How you read that may be less clear but participants should be pushing for meaningful information which would of course include the nature of the drug and the evidence base for trialling it.
 
Jonathan Edwards said:
There is a legal requirement to obtain informed consent and that requires adequate information. How you read that may be less clear but participants should be pushing for meaningful information which would of course include the nature of the drug and the evidence base for trialling it.
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Wouldn't you need to give info about the drug in case there are issues with something else that someone is taking (I guess they could exclude people taking other medications).
 
sneyz said:
Hmm. Any information on ‘PHOE-01’, or is it just a pseudonym? Looking at a few of the recent publications she’s been involved with Ebselen might be a candidate.
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I think we'd just be guessing at trying to make sense of this drug identifier. There are so many different possibilities, including that the identifier doesn't really mean much at all.
 
Adrian said:
Wouldn't you need to give info about the drug in case there are issues with something else that someone is taking (I guess they could exclude people taking other medications).
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It would be up to the trialists to ensure safety. Giving patients that sort of information would not be valid 'informing' because they could not be expected to be able to interpret it.
 
sneyz said:
Hmm. Any information on ‘PHOE-01’, or is it just a pseudonym? Looking at a few of the recent publications she’s been involved with Ebselen might be a candidate.
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Ebselen is a decent guess, it's a glutathione mimetic and the most recent study of Beata Godlewska was measuring glutathione in me/cfs.

But the dosing is very different, the protocol for me/cfs looks to be 15mg ramping up to 30mg, whereas they're handing out 400-1200mg for other conditions. And from what I'm reading Ebselen is owned by a US company, not these Germans. It is a mystery!
upload_2025-2-7_21-27-8.png
 
Jonathan Edwards said:
You could ask them for some information - real information.
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I'm happy to do that, certainly. I'm in a deep crash today so haven't been able to read previous thread posts properly enough to understand if it has already been suggested what the real information to ask for would be.
Is it literally what the drug is? (that would be real information?)
 
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