Open Norway: Study of Daratumumab Injections for Patients with Moderate to Severe Chronic Fatigue Syndrome, 2025

And if there wasn’t massive social and institutional and infrastructural inertia behind the car being used for transport, it would probably be far more regulated than now.

Kind of like alcohol (alcohol is more dangerous than something like cannabis in practically every way).

Both alcohol and cars lead to a massive amount of preventable deaths, but they’re so engrained in our cultures its political suicide to try and do something big about it.

https://en.m.wikipedia.org/wiki/Path_dependence

 

Yes I would also take this risk in a heartbeat but would have to think very hard if I was mild and things continue to pan out as JE has been talking about with the science.

 

Yeah, I agree. Also, temporary immune suppression—for a number of weeks—is one thing, but even as a moderately ill person I wouldn't choose a drug that caused significant immune suppression in the long term. Not for ME/CFS at least.

The risk/benefit calculation is very different for people who're severely ill, of course.

 

I very much agree. I have a lot of respect for Fluge and Mella. Not so much for those selling the drug as a treatment before the research is there for people to be able to make in informed choice.

Have I missed something here? If so, can someone point me in the direction of relevant thread? ty

 

Nothing specific but I am optimistic that enough good people are focused on the problem now that we will get some answers about mechanisms reasonably soon.

 

Thank you, that's good to hear!

 

From an email response from Haukeland—phase 2 is RCT with 66 patients. Better news!

“Thank you for your message. I can confirm that we are planning a phase 2 trial of daratumumab at Haukeland - an RCT with 66 patients. However, we are still awaiting the final approvals from the Norwegian Medical Products Agency, and so we have not yet published any recruitment info for the trial. I believe the information you have found concerns the pilot study we have performed in preparation for the trial. I understand that on some websites advertising clinical trials it still comes up as recruiting. The data for the first ten patients has been submitted for peer review and will hopefully be published in not too long. Dr. Fluge will talk about the results from the pilot in some more detail in Stavanger, although he will still be somewhat limited by the restrictions posed by the medical journal reviewing the manuscript.
Regarding your question on isatuximab, this is a drug that our doctors have looked into. However, as daratumumab is an older drug, there is more experience with the drug also in autoimmune diseases, and the toxicity profile is better known, and so our assessment is that the risk in testing the drug in a new population is acceptable.”

 

66 is more than I expected!

I’m hoping RCT means blinded in this case.

 

Screenshot from the Berlin ME/CFS Conference that happened a couple days ago:


Transcription of Dr. Mella describing this:

 

3 months run in before the intervention - that really should be the minimum standard for most ME/CFS studies!

 

Everything looks wonderful except for HADS.

 

It might be useful if it shows that HADS can change in non-responders? Essentially proving the uselessness of it as an outcome.

I sincerely doubt that they will claim any benefits if only HADS changes. But I understand your apprehension!

 

It would be nice if they did period monitoring of sleep. This can be done inexpensively with at home sleep tests. Or at least a questionnaire—are you sleeping through the night, how many wake-ups during the night, etc.?

 

Aren’t those quite unreliable?

 

Probably good enough to see if you are sleeping through the night, etc.

 

In my experience i wouldnt trust them to diagnose sleep problems. But they definitely get the trend right like if im sleeping more they will reflect that or if i wake up less often during my sleep they will reflect that as well.

 

Yes. Apparently head electrodes and cameras are needed even to show whether or not someone is asleep, never mind determine what stage of sleep they're in. That's why specially equipped labs are used for diagnosis.

The watches are consumer gadgets that record heart rate and how much the wearer was moving, then make a guess. It's not feasible for them to do any more than that.

 

FWIW Haukeland does have a sleep lab.

https://www.resmedjournal.com/article/S0954-6111(22)00125-1/fulltext