Rapamycin Pilot Treatment Trial for ME/CFS

Perhaps the larger number is to enable subgrouping once they have the biological data for all the patients before and after treatment. Given that it's not blinded, I'm not sure what the point is of having a separate comparison group for their biological testing.
 
Adrian said:
Are they charging participants?
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I guess that it is highly likely that the treatment will occur in the context of paying for consultations at least.

Milo said:
to gain wider knowledge about response to start with
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The problem is that in this context you cannot get any meaningful evidence of 'response' unless it is large and consistent - in which case ten patients would be enough.
 
Jonathan Edwards said:
This isn't actually the case. In this sort of situation going straight to a double blind controlled trial would be reasonable. If this is just a study of pharmacodynamics - effects of drug on pathways - then I do not see the reason for the size.

When I looked at rituximab for RA I did a tiny trial of 5 patients to show a biologic effect and went straight to a definitive double blind controlled trial with 160 patients. This study does not even appear to be a registered trial.
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I agree with all the criticism.
If I would be a RA patient I would be very disappointed with this trial.

Unfortunately in the world of ME CFS patients, this is as good as it gets.
Maybe there is 1, maybe 2 double blind controlled trials taking place for ME CFS at this moment.

So, although heavily flawed, I’m already happy that this research potentially can bring us one tiny little step forward to understanding and treating MECFS.

Longing for the day that we will be able to enforce the same high standards existing for other immune illnesses with the same rigorisity to all future ME CFS research.

#RealPolitik
 
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So has this 'trial' been through peer review of any sort I wonder?
I think it is fine to ask for charitable donation but normally that is to provide funds for projects independently deemed of value, like DecodeME. Even with a peer review system things can be pretty random but without it there is no guard against patients pouring money into projects that will tell us nothing.
 
My understanding from Cort Johnson’s two blogs on rapamycin on healthrising.org on July 6 and Nov 14, 2023 is that the Simmaron study is “designed to provide data needed to get funding for a more rigorous placebo-controlled trial.”

More information on rapamycin treatment can be found on Dr Alan Green’s site rapamycintherapy.com as well as in the published papers
of Mikhail Blagosklonny and Matt Kaeberlein, whom Green calls the foremost experts on the theory and practice of rapamycin. Veronica Galvan’s group in San Antonio Texas is also doing excellent research on rapamycin, using mice. Green has the largest clinical practice and experience so far with rapamycin treatment.

The usual effective dosage for
people is 6mg once a week, but Green says it can be as low as 2mg every 3 weeks. Side effects are minimal, unlike the serious side effects with the high doses needed to prevent the rejection of organ transplants. Green also explains why taking rapamycin every day will be ineffective, and research studies in which this is the protocol show no benefit.
 
The trial registration was updated a few days ago:
  • The enrollment has increased from 100 to 150
  • People with long COVID are now eligible to participate as well.
  • Primary outcomes have been expanded from just SF-36 to also include MFI and Bell scale.
ClinicalTrials.gov

Edit: This is interesting because someone recently posted on Reddit that they are in the study and it is finishing up. Maybe a sign of encouraging results so they want to expand to long COVID?

Though there are probably other possibilities. Maybe they had no good results so they wanted to give it a shot with LC before giving up on this drug.
 
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