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

There are some on X speculating that it might be Amifampridine, a potassium channel blocker.

 

They replied to my email and referred me to this link (the patient information for the trial) - https://cdn.prod.website-files.com/...ormation Sheet_v2.0 23Sep2024_Clean.docx .pdf

Does that shine any light at all?

 

Afraid not.

 

That info sheet's terrible. Nothing about what it is (except that it might interfere with contraception or egg or sperm quality), and nothing about why they think it might help.

If it's a drug rather than a food supplement, where's all the small print about contraindications and possible side effects? Surely people should be able to read that and weigh it up themselves, rather than relying on a risk assessment by a clinician who's never met them and presumably doesn't have access to their medical records.

 

Yes, thinking back to information sheets I have written this is hopelessly inadequate. I always explained what the drug was supposed to do and why we thought that might help.

 

I think we can safely conclude that it seems they don't want patients to know which drug this is, but they are probably underestimating our ability to figure it out (I think Amifampridine is a good guess).

 

This is one of the things we should be putting in the suggested factsheet for patients who are considering being in a trial.

 

I hadn't caught up with that factsheet yet!

 

It doesn't exist yet, but @Kitty suggested it and the idea went down well on the thread.

 

That sounds pretty unethical to me.

 

It is. But probably not so unusual.

 

I was able to find a list of side effects at that link shared by @josepdelafuente above and they include a 1 in 10 chance of reduced sense of touch. That seems like a rare side effect and it is a side effect of amifampradine, listed as a 1 in 10 chance by the EU. https://www.ema.europa.eu/en/documents/product-information/firdapse-epar-product-information_en.pdf

Tiefenbacher recently started marketing that drug in the EU: https://tiefenbachergroup.com/2025/...rmaceuticals-new-market-launch-amifampridine/
So the drug is likely amifampradine.







It seems to work on potassium and calcium channels.

Amifampridine blocks voltage-dependent potassium channels, thereby prolonging pre-synaptic cell
membrane depolarisation. Prolonging the action potential enhances the transport of calcium into the
nerve ending. The resulting increase in intra-cellular calcium concentrations facilitates exocytosis of
acetylcholine-containing vesicles, which in turn enhances neuromuscular transmission.
It improves muscle strength and resting compound muscle action potential (CMAP) amplitudes with
an overall weighted mean difference of 1.69 mV (95% CI 0.60 to 2.77)

 

Most of the possible side-effects are already symptoms of ME!

 

Ah. Good detective work!
Is amifampridine a promising candidate for us?

Ironically it looks like I probably can't take part in the trial due to my occasional recent use of herbal-infused chocolate to ease some of my M.E pain and malaise symptoms!

 

Fampride (which is supposedly somewhat similar to Amifampridine but not quite the same) had a large Phase 2 trial for Long-Covid aimed at cognitive perfomance with negative results, that's all I know.

 

I’d hoped any drug trials we saw in the UK would have been done by people who cared about or at least understood ME/CFS. This all looks very generic and boilerplate.

 

I've emailed to ask outright what the drug is, saying that I couldn't give informed consent unless I knew.

If they tell me, I'll ask if I can share the reply; if they say no, others could ask directly too.

 

Great, nice one Kitty.

 

I tried signing up, but it seems that they don't want those with moderate ME/CFS symptoms. I tried both 'able to work 50%' and 'able to work 100% as long as not strenuous' and neither were suitable.

I also tried another time and ticked that I got ME/CFS from COVID (I didn't). This caused me to become ineligible straight away before I got to the severity questions.

This might fit with the drug being Amifampridine or Fampride. If there's already a negative trial in long COVID, they probably aren't going to want to include those with ME/CFS from COVID.

 

Press release: 'Lindus Health and Tiefenbacher Group Launching Clinical Trial to Advance ME/CFS Research and Treatment'