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Cortene Peptide for MECFS? "Curative"?!

Messages
30
Location
Suffolk, UK
hi, on page 4 of this thread, Vortioxetine is mentioned (brand name Trintellix in the US, and Brintellix here in the UK) - a med by Lundeck of Denmark. I have just started this medication and can feedback if anyone is interested ?

It's pharmacodynamics state that receptor 5-HT1A is agonised to 15 Ki (nM), which is a pretty decent agonist for that receptor.
 

Hip

Senior Member
Messages
17,824
I have just started this medication and can feedback if anyone is interested ?

I'd be interested in hearing the feedback. What is the reason or rationale for taking vortioxetine? It's normally used to treat depression, and also improves cognitive performance. Was it prescribed by a doctor or did you obtain it yourself?
 

Hip

Senior Member
Messages
17,824
@asymmetry, be interested to get your feedback on vortioxetine once you have tested it out for a few weeks, and perhaps have increased the dose. Might be worth starting a new thread on vortioxetine if you find it helps the brain fog of ME/CFS.
 
Messages
30
Location
Suffolk, UK
@asymmetry, be interested to get your feedback on vortioxetine once you have tested it out for a few weeks, and perhaps have increased the dose. Might be worth starting a new thread on vortioxetine if you find it helps the brain fog of ME/CFS.

Sure, will do. A new thread is a good idea as I was searching for people's experiences with vortioexetine. There isnt much around really, I think it's because it's a relatively new med. I'm also trying it to see if it helps with my CFS/ME symptoms and just calm everything down. I get a cold at least every 10 days which ends up as gastro symptoms and then on to mental effect from there. I've checked my immune system, I've been to a gastroenterologist, and this is the end of the line now.
 

wigglethemouse

Senior Member
Messages
776
FYI everybody, the Cortene website has been updated and there is lots of interesting stuff on it (and it's explained in language even I can understand!)

This is a key part from their website
4. In the most effective dosing group, symptom improvement was:
  • substantial (average 26%);
  • effective on all monitored symptoms;
  • immediate (with 1-2 days of treatment);
  • persistent (at least 28 days); and
  • statistically significant (p=0.009).
You can view the actual results here. It shows that the "most effect dosing group" with p=009 statement above was the second lowest dosing group of "Subcutaneous infusion of CT38 at 0.03 μg/kg/hour, for 3.5 hours on each of 3 days"
https://clinicaltrials.gov/ct2/show/results/NCT03613129

Which makes this statement on their website is a bit strange
5. Symptom improvement was related to total dose, suggesting that increasing the total dose could reduce symptoms further.
In fact the highest dosing led to serious adverse events, which they blamed on incorrect infusion protocol.
 

Bergkamp

Senior Member
Messages
145
I assume a 26% improvement in symptoms is going from 10% to 36% activity level (instead of 26% ‘growth’, i.e. from 10% to 12.6%)? Whichever the case, 26% is a tad bit disappointing in my opinion..
 

Neunistiva

Senior Member
Messages
442
So what’s the next step? And general timeline on how long before it could possibly be available. Idk about everyone else, but I’ll gladly take a 26% reduction in symptoms

If this was true improvement, and not just placebo effect or some artefact, I wholeheartedly agree I would gladly take it.

I am completely bedridden and completely dependent on the help of my parents. 26% improvement would mean I would be able to go to the bathroom on my own or get a glass of water of my own, and wouldn't have to wake them every night multiple times. It would mean an improvement in sleep quality. It would mean I would be able to speak to them more than a few sentences every day. Sounds like heaven :)

That would be a huge improvement in the quality of life for my whole family.
 

Bergkamp

Senior Member
Messages
145
If this was true improvement, and not just placebo effect or some artefact, I wholeheartedly agree I would gladly take it.

I am completely bedridden and completely dependent on the help of my parents. 26% improvement would mean I would be able to go to the bathroom on my own or get a glass of water of my own, and wouldn't have to wake them every night multiple times. It would mean an improvement in sleep quality. It would mean I would be able to speak to them more than a few sentences every day. Sounds like heaven :)

That would be a huge improvement in the quality of life for my whole family.

Of course, I’d love a 26% improvement too, it’d make a huge difference for a lot of people. I’m not arguing 26% isn’t much, I’m just saying that this company claimed it to be ‘curative’ (see the title of this thread) and 26% improvement is quite far from a cure.
 

JES

Senior Member
Messages
1,320
As was pointed out, 26% improvement is a pretty pointless number unless we know the context. The clinical trial website linked above mentions Total Daily Symptom Score (TDSS) as primary outcome. It only includes patient-reported subjective measurements. The trial wasn't randomized and there was no placebo. So if the 26% improvement number is taken from that outcome measure, it tells us almost nothing, it's in the ballpark of PACE trial improvement and I reckon also worse than Rituximab phase 1, where many patients improved much more than that.
 

borko2100

Senior Member
Messages
160
26% is very low indeed. I dont know what they were exactly measuring, but if it was activity level, then 26% is nothing. Just do the math, if a normal person does let's say 5000 steps per day and a CFS/ME person does 1000, then in order to reach a normal level the CFS person needs an increase of 4000 steps, which translates to 400%!

The more debilitating the disease the bigger relative improvement (%) is needed in order to cure it. So in the case of ME/CFS a 26% improvement isn't going to cut it.

So either this was a placebo or it provides a very slight benefit, which could possibly be achieved with other treatments as well.
 

Bergkamp

Senior Member
Messages
145
26% is very low indeed. I dont know what they were exactly measuring, but if it was activity level, then 26% is nothing. Just do the math, if a normal person does let's say 5000 steps per day and a CFS/ME person does 1000, then in order to reach a normal level the CFS person needs an increase of 4000 steps, which translates to 400%!

The more debilitating the disease the bigger relative improvement (%) is needed in order to cure it. So in the case of ME/CFS a 26% improvement isn't going to cut it.

So either this was a placebo or it provides a very slight benefit, which could possibly be achieved with other treatments as well.

This is incorrect. The 26% is most likely an increase in activity level, i.e. going from 10% activity (a normal person being 100%) to 36%. What you are describing, is 26% as a growth factor, which would be going from 10% to 12.6%. That’s probably not it.

It still isn’t much though.
 

borko2100

Senior Member
Messages
160
This is incorrect. The 26% is most likely an increase in activity level, i.e. going from 10% activity (a normal person being 100%) to 36%. What you are describing, is 26% as a growth factor, which would be going from 10% to 12.6%. That’s probably not it.

It still isn’t much though.

Then they should have said "an increase in 26 percentage points" not a 26% increase. Also it seems unintuitive to measure activity level using a 0 - 100% scale.
 

nryanh94

Senior Member
Messages
165
I emailed Cortene and got the following response:

Regarding the 26% improvement, this was the average improvement. The more drug exposure patients got the better was their improvement (generally). The two patients within this group who received the greatest exposure improved closer to 45%. As to how this was calculated, patients self-reported on 13 symptoms using a scale of 0 (no symptoms) to 5 (severe symptoms). Therefore, a maximum score of 65. We collected reports daily for 28 days before treatment and 28 days before exit from the trial. The percentage refers to how much their symptom scores declined (average total daily symptom score). That is, in the best cases, symptom scores were almost halved. Based on the fact that more exposure generally led to more improvement, we expect that additional exposure will reduce symptoms even further.

As to a timeline, getting a new drug approved is a long process. We will need to run at least two more trials before we can apply for FDA approval. Best case, these will each take a couple of years.”
 

JES

Senior Member
Messages
1,320
Nice work, so counting it that way, it does seem more statistically significant. However, it's still an unblinded trial with subjective measures only, which is unreliable as we have learned from PACE and other BPS model trials. If you repeat the same procedure with placebo pills the expectation is to find a drop in scores there as well so how much significant this really is, I guess we'll find out in a couple of more years. :meh:
 

jaybee00

Senior Member
Messages
592
Regarding the 26% improvement, this was the average improvement. The more drug exposure patients got the better was their improvement (generally). The two patients within this group who received the greatest exposure improved closer to 45%.

But this was not what their data shows as @wigglethemouse showed.

This is a key part from their website

You can view the actual results here. It shows that the "most effect dosing group" with p=009 statement above was the second lowest dosing group of "Subcutaneous infusion of CT38 at 0.03 μg/kg/hour, for 3.5 hours on each of 3 days"
https://clinicaltrials.gov/ct2/show/results/NCT03613129

Which makes this statement on their website is a bit strange

In fact the highest dosing led to serious adverse events, which they blamed on incorrect infusion protocol.


Sounds like a bit of BS.