News From Jarred Younger / Neuroinflammation, Pain, and Fatigue Laboratory at UAB, From Aug 2020

Mij said:
Years ago I took the first dose listed - 1.5mg It was unpleasant and gave me terrible insomnia.
Click to expand...
To be fair most people now start extremely small doses then work up to that. All the way to 4.5mg. That being said I had an unpleasant experience with it and didn’t help me one bit even titrating up small doses.

I thought Jared wanted to try a different form of the drug? He’s just doing regular old LDN? Why….
 
1 month baseline period, 8 months drug period.

No placebo control. Only blinding of participants.

PROMIS Fatigue Short Form 7a as primary outcome. No mention of other outcomes. Weekly measurements.

Because LDN might not be expected to show a dose response relationship, I think they need a placebo control. I’ve seen a few anecdotes of people saying they had no reaction at all to LDN, so unblinding from side effects might only be a partial issue. And you could always think you’ve just got too low of a dose if nothing happens.
 
ChronicallyOverIt said:
If it’s truly not the former, dextro, I would argue that anyone that donated to this study was misled by the last video
Click to expand...
I swear he said he was setting up to a trial of dextro. I don't see the point of running another LDN trial from Dr Younger, we already have some on the go. The proposition of the dextro version however seemed more compelling and different to what others were doing.
 
Last edited by a moderator:
Utsikt said:
I’ve seen a few anecdotes of people saying they had no reaction at all to LDN, so unblinding from side effects might only be a partial issue.
Click to expand...

The best side effect I had were vivid dreams. I miss those lol.

ChronicallyOverIt said:
If it’s truly not the former, dextro, I would argue that anyone that donated to this study got scammed?
Click to expand...

Agreed. What's going on? Were people donating to a study or to get dextro manufactured? Or both? I don't recall.
 
Didn't he just get funding for dextro a few weeks ago? Would have been really fast to have a protocol registered already, right? I assume that'll start after some time.

Seems like a good thing to have a dose-response study on LDN finally, even if unblinded.
(Edit: doses are blinded)
 
forestglip said:
Main points:
  • The recently posted study is just meant to determine the best dose for a future larger efficacy trial.
  • It's not yet recruiting or funded. Posting the protocol was the first step in the process to get funding.
Click to expand...
The question is why this is necessary at all when there are 2 RCTs for ME/CFS due to report fairly soon? Maybe for replication?
 


He discusses the paper re-analizing the GWAS study by Decode ME. To me, the paper doesn't do much more than reaffirming the genetic link of ME/CFS. He seems to go a little too far linking it to the idea of subtypes though. Perhaps he is laying foundation for his upcoming paper for neuroinflammation study which shows a subset of the patients showing the neuroinflammation. I do subscribe to the idea that each ME/CFS case having "personality" in both symptoms and responses, but I'd be wary of causal subtypes.

​

 
Chandelier said:
Click to expand...

Supposedly starting in September 2026, said it will run 1-2 years, with brain scans of people who respond. Seems like that could be cherry-picking but also would have to see the full design.

Honestly disappointed it’s LDN and not the special naltrexone he was talking about earlier. In 2-3 years we’ll get results on an already failed drug (from other RCT’s) that the patient population says kinda works sometimes. Seems like a waste of time and money in my opinion, but if he does a long trial it will answer some questions about treatment length playing a factor. Still I think there is much more promising things to follow through on, POTS blood volume testing, buspirone challenge etc…

I also find amusing that he talks about the Nacul trial with surprise, you’d think you’d Google people running RCT’s for the same drug before embarking on a trial yourself…
 
Younger's (unfounded? blind?) allegiance to LDN reminds me of the non-profit that refused to give up on Flexeril (cyclobenzaprine)--and now the FDA finally approved the pharma end product, sublingual version called Tonmya. Which, while causing fatigue as a side effect purports after 14 weeks to show reduced pain, fatigue, cog dys.

(I thought the original hypothesis behind Flexeril for FM was that it increased time spent in Stage 4 sleep where muscle repair takes place---and so the old theory was that this would "heal" FM muscle pain. At least this was my take back at least a decade, so who knows...)
 
ChronicallyOverIt said:
Supposedly starting in September 2026, said it will run 1-2 years, with brain scans of people who respond. Seems like that could be cherry-picking but also would have to see the full design.

Honestly disappointed it’s LDN and not the special naltrexone he was talking about earlier. In 2-3 years we’ll get results on an already failed drug (from other RCT’s) that the patient population says kinda works sometimes. Seems like a waste of time and money in my opinion, but if he does a long trial it will answer some questions about treatment length playing a factor. Still I think there is much more promising things to follow through on, POTS blood volume testing, buspirone challenge etc…

I also find amusing that he talks about the Nacul trial with surprise, you’d think you’d Google people running RCT’s for the same drug before embarking on a trial yourself…
Click to expand...
I agree with you, for me this is really disappointing for various reasons.

First the general fixation on LDN. I mean there are many people way worse than me, lying in dark rooms, no stimuli or even people dying from ME and pretty much all of them have tried LDN to no avail, yet this is the things that gets more funding, this is the thing some researchers are choosing to focus on instead of trying to figure out disease mechanisms and treatments for those very severely affected people.

Furthermore the trial is not placebo controlled and there already is an LDN trial ongoing from which we hopefully will learn something about dose finding, in the LIFT trial they start with 1.5mg, titrate up to 4.5 mg and let people scale back if they feel bad. Dr. Youngers trial doesn't have such an option or any titration procedure, so he'll never know if the persons with 1.5mg were responders but had a too low dose or if people with higher doses would've been able to tolerate those if they had started lower. With this - with all due respect - sloppy design you can almost guarantee that hardly anyone will profit from doses >3mg. And then to top it off using the promis fatigue score as a primary outcome measure, a questionnaire where 6/10 (!) items are just about being tired. That's bordeline embarrassing.

I would have thought that after all these years holding on to LDN and working on ME Dr. Younger would at least know about the uselessness of these vague fatigue scales and patient experiences with LDN and that most people need to start low, no matter what dose they end up taking and would have been able to design a trial accordingly.

To end let me say I am really sorry if this whole reply is to harsh, you can of course delete it in that case. I am just really frustrated and personally so tired of people treating LDN like a wonder drug and even more tired of those sloppy and in this case seeminlgy almost careless trial designs.
 
You must log in or register to reply here.
Back
Top Bottom