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

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

 

Seems to be related to work of Dr Beata Godlewska at Oxford, discussed here: https://s4me.info/threads/universit...drome-closes-30th-dec-2022.23609/#post-394994

 

Even though it’s remote — they aren’t accepting severe people

 

Seems to be very little explanation of what the drug is.

 

This looks very paternalistic (maternalistic?). I would want at least some indication of what the 'treatment' is and why it is thought to be promising.

Judging by the other thread material referred to this looks like a non-starter.

 

I think Lindus Health is just running the trial — the 'CRO'. They aren't a pharmaceutical company. They seem like a healthcare startup for doing clinical trials.

The trial sponsor seems to be Alfred E. Tiefenbacher GmbH.

 

I wouldn't want to take a medication without knowing what it is and what the risks are. Especially not alone at home—what if I was allergic to it?

 

I'm wondering if this is not more likely to be some sort of supplement formulation, given Dr Godlewska was doing work on creatine (I think).

 

Is there not a legal requirement to tell participants what drug they will be taking?

 

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.

 

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.

 

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.

 

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.

 

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!

 

I'm in the UK, I'm not severe... I could do it.
Should I bother?

 

You could ask them for some information - real information.

 

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?)

 

Yes and why they think it might help. They could provide an explanation for why patients should be interested for S4ME.

 

Ok, I've sent an email asking those questions. Will update here if they reply.