Autifony Therapeutics Phase II Study for AUT00063, for the Treatment of Hearing Loss and Tinnitus

[Steve]

Understood, I'm hoping you find some relief. Thanks for the reply!
Any chance you can post a pic of the tablet ? Not sure if that's ok or not....mods? @Markku @Steve

I would say maybe not. What we don't want to do is have any kind of impact on the trials - if the placebo pills are different in appearance to the actual treatment then anyone who sees it will know which they are on. It wouldn't be right to have an influence like that and potentially wreck their results (think of all the people viewing the thread who are probably searching either when they start or when they register for the trials).

If we know that they aren't then I can't see any issue.

 

[Rube]

I would say maybe not. What we don't want to do is have any kind of impact on the trials - if the placebo pills are different in appearance to the actual treatment then anyone who sees it will know which they are on. It wouldn't be right to have an influence like that and potentially wreck their results (think of all the people viewing the thread who are probably searching either when they start or when they register for the trials).

If we know that they aren't then I can't see any issue.

Good point Steve. My guess would be in a double blind trial they should be identical in appearance but just in case they are not then probably not a good idea to post a pic.
@chamferman please disregard pic request.

 

[OddV]

Maybe send pics to the mods and then they can make a determination?

 

[jeannie]

good luck to all those going into/ or in the trial!! praying this will be all of our ticket for a cure or relief!!!please keep all of us updated!!

 

[amandine]

I would say maybe not. What we don't want to do is have any kind of impact on the trials - if the placebo pills are different in appearance to the actual treatment then anyone who sees it will know which they are on. It wouldn't be right to have an influence like that and potentially wreck their results (think of all the people viewing the thread who are probably searching either when they start or when they register for the trials).

If we know that they aren't then I can't see any issue.

Cant see there being any different appearance between the real drug and the placebo otherwise the docs and nurses would know when they are giving real or placebo drug to trial volunteer. In that case would not be a double blind trial at all............surely

 

[Shaun]

Hi as you may know I have managed to get a placement on the trial I just wanted to give an update as to where I am with my t. Mine was a 9/10 at the offset but now down to a 2/10 most days and 5/10 on bad days ,to be honest I was apprehensive about joining trial as I felt there might be someone more derseving of a placement than myself.
But I suppose what is for you will have,and I do miss out on a lot of things so decided why not go for it this is not just about me.

I am also intrigued to see weather I could get this bad boy gone for good and will go with the flow...pardon the pun....
It would be great if this is the cure we have been waiting for or at least something which could lower t to a non entity.

out of all the so called cures I have seen on this forum aut00063 has been the only one which has stood out to me for all the right reasons.
I have a consultation this week to see if im eligible for trial will keep you updated
Keep the faith.

 

[PhilB]

Cant see there being any different appearance between the real drug and the placebo otherwise the docs and nurses would know when they are giving real or placebo drug to trial volunteer. In that case would not be a double blind trial at all............surely

I can confirm that the doctors and nurses dispensing the pills will not know who is getting the real drug and who is getting the placebo. However, this does not necessarily mean that real drug and placebo are identical in appearance. It just means that (if they are not identical) the hospital staff will not know which is which. That is why I agree with @Steve on this one. Unless we can get confirmation that the real drug and placebo are identical, it would not be advisable for any trialees to post photos of their medication. The last thing we would want is for this forum to be accused of facilitating any sharing of information amongst trialees which might compromise the integrity of the trial.

 

[Shaun]

I agree with you phil,I have no intention of posting photos anyway.
what it looks like is irrelevant it's weather we get the real thing and that it works.
simples.

 

[sergerold]

I would say maybe not. What we don't want to do is have any kind of impact on the trials - if the placebo pills are different in appearance to the actual treatment then anyone who sees it will know which they are on. It wouldn't be right to have an influence like that and potentially wreck their results (think of all the people viewing the thread who are probably searching either when they start or when they register for the trials).

If we know that they aren't then I can't see any issue.

If they're different then surely that's a severe defect in the design of the study?

 

[Valentin]

If they're different then surely that's a severe defect in the design of the study?

the morning pill might even have a different colour than the evening pill to serve as a reminder , that's hardly a defect

 

[sergerold]

the morning pill might even have a different colour than the evening pill to serve as a reminder , that's hardly a defect

?
I'm talking about the differences between the placebo and non-placebo drug. Surely, they should look the same for the precise reason given in this thread?

 

[Shaun]

I'm sure that the trial officials got that covered surely??
Or else it's a silly oversight on their part
anyway all this talk of placebo there Is a very good chance that the we get the real deal,we need some positivity.....

 

[preslys]

There are 4 people take part in the study member in this forum
and there are 152 people with tinnitus may take part in the study and only half of them will receive the real drug
so we have only 2/152 chance to get the real drug.

 

[attheedgeofscience]

There are 4 people take part in the study member in this forum
and there are 152 people with tinnitus may take part in the study and only half of them will receive the real drug
so we have only 2/152 chance to get the real drug.

Not quite...

If all four people are enrolled, and the trial is perfectly randomized with a 50% chance of the real-drug, the likelihood of all four participants ending up with the placebo is (1/2)^4 = 6% (roughly). The chance of at least one of them getting the real drug is 94%.

 

[Viking]

anyway all this talk of placebo there Is a very good chance that the we get the real deal,we need some positivity.....

I agree. We must consider that there are others people on trial who don't want (or don't know the website) talk about this experiment. We are talking about an "experiment"! Right or wrong? This is a phase study 2A. Unfortunately it will take a long time before the results are disclosed.
If we for example go on google and type (I speak of an existing drug): retigabine clinical trials, we will discover easily that the study of a molecule such as this additional (then existed drugs for epilepsy) lasted a total of six years https://clinicaltrials.gov/ct2/show/NCT00235755.
From 2005 until his approval and sale in 2011. I do not want to be pessimistic, but I think it's a bit out of place to mention that long of a clinical trial is only the second phase. It creates anxiety, confusion, false hope, euphoria unfounded ... I do not know but I think that these discussions are not "productive." We know there are several ongoing studies, but, at least I do not want false hope. If this molecule will work, will be the first in the world! So there will be very extensive studies before its dissemination. It is not a pessimistic speech, but unfortunately realistic. Think about other big pharma are already creating a formula of retigabine with a lower side effect profile. It is only an example. I prefer to not know!
Best wishes to all heros!

 

[amandine]

and often in these trials they end up having more trialees than originally agreed. In fact the lady I spoke to told me that if there were more eligible people and the trial was still running, then her clinic would continue to take more even if they had reached their quota..........her words were ''the more, the better" so maybe it is not an expensive trial for them to carry out or something.

 

[amandine]

@attheedgeofscience

I dont know how you do it! I am sure you are correct but I have absolutely no idea how you did those maths LOL!!! I have tried it several ways but cant get to it.....obviously I am not a trained mathematician (sadly) but would love it if you can explain it to me even in a pm if you prefer cos it is not important to the public debate - but personally important cos i genuinely want to understand the maths of it.
If you dont mind and you have a spare moment?

thanks hopefully

If all four people are enrolled, and the trial is perfectly randomized with 50% chance of the real-drug, the chance of all four participants ending up with the placebo is (1/2)^4 = 6%. The chance of at least one of them getting the real drug is 94%.

 

[preslys]

From 2005 until his approval and sale in 2011. I do not want to be pessimistic

At the end of phase two if the drug is effective, we can make the pressure on our government to approve and to market it as soon as possible. we can do it bye ATA and other associations in the world.

 

[Viking]

At the end of phase two if the drug is effective, we can make the pressure on our government to approve and to market it as soon as possible. we can do it bye ATA and other associations in the world.

Yes i agree. My thoughts had turned to a past that I lived with a molecule that seemed to be promising (the neramexane) and then instead left me with a terrible bitterness in my heart when I read: "Failed in phase 3".
I wanted to die. I apologize, my thoughts do not want to be pessimistic, it's the opposite, I look for hope. Real hope for everyone!
Best wishes!

 

[attheedgeofscience]

I am sure you are correct

As someone with a background in financial mathematics, probability and statistics is not my main specialty, but if my memory on probability serves me correct, then this is the (correct) justification:

Probabillity is divided into independent and dependent events. Independent events are generally easier to deal with.

So picture the 152 AUT-63 drug packages being placed in a non-see through bag. With 50% chance of a placebo, 76 of them are AUT-63, 76 of them are placebo. Agree? You are blind-folded as you choose the 4 of the 152 drug packages in order to make the selection unbiased.

In the above scenario with a 50% probability of each event, the selection process is like flipping an unbiased coin. Heads or tails... 50% chance of either event. What is the chance of flipping 4 tails in "one go" (i.e. one after the other). Well, the probablility is:

P(T)*P(T)*P(T)*P(T) = (1/2)*(1/2)*(1/2)*(1/2) = 6.3%
The probability of "all other events" is therefore 1 - 0.063 = 0.937 = 93.7%

"All other events" includes just 1 person ending up with AUT-63, 2 people with AUT-63, 3 people with AUT-63 and 4 people with AUT-63. So the chance of at least one person (out of the 4 enrollments) ending up with the drug is 94%...

The above assumes an independent selection event (i.e. with replacement of each drug package to the bag after it has been drawn). In reality it is not an independent selection as each participant holds on to the drugs package after they have received it (i.e. a dependent event). So...

P(placebo 1st draw)*P(placebo 2nd draw)*P(placebo 3rd draw)*P(placebo 4th draw) = (76/152)*(75/151)*(74/150)*(73/149) = 6.002%.

Because the selection is being done from a large number of packages, dependent events can be approximated by independent events (in this case; not so when selecting from a small sample e.g. "10"). You can calculate the difference in the approximation by...

P(independent) - P(dependent) = 6.250% - 6.002% = 0.248% (this is the error involved with the assumption - i.e. "small").

And that's stretching my memory a little...

 

[Mark662]

Crikey! I want @attheedgeofscience in my team

 

[amandine]

As someone with a background in financial mathematics, probability and statistics is not my main specialty

Not your speciality? phew!! and you can do that with T?? wow! and T is said to disturb concentration? obviously not! i agree with Mark, we need you on our team!
thank you!

 

[Champ]

and often in these trials they end up having more trialees than originally agreed. In fact the lady I spoke to told me that if there were more eligible people and the trial was still running, then her clinic would continue to take more even if they had reached their quota..........her words were ''the more, the better" so maybe it is not an expensive trial for them to carry out or something.

Making the drug isn't hard since they have machines that are built to do this sort of thing. The data is the valuable part that is harder to come by since that requires human intervention to produce.

 

[chamferman]

A quick update for 4th day on trial

Only effect I have experienced that could be considered a side effect, is I have been feeling quite tired the last couple of days, but that could be just down to life in general.

Tinnitus loudness yesterday was an 8/10 and today woke up to a 5/10.

 

[preslys]

A quick update for 4th day on trial

Only effect I have experienced that could be considered a side effect, is I have been feeling quite tired the last couple of days, but that could be just down to life in general.

Tinnitus loudness yesterday was an 8/10 today and today woke up to a 5/10.

Goods news
it means that the drug work

 

[OddV]

Goods news
it means that the drug work

Not to be rude, but how can you make this assertion after he's only been on it for 4 days? Yes, it's encouraging, but let's let him get some more time under his belt before a win is declared.

 

[amandine]

A quick update for 4th day on trial

Only effect I have experienced that could be considered a side effect, is I have been feeling quite tired the last couple of days, but that could be just down to life in general.

Tinnitus loudness yesterday was an 8/10 and today woke up to a 5/10.

Just wanting to clarify something please. Did you have fluctuations before taking this drug ie did it go up or down before in noise loudness or was it consistent every day? Is this the first time that it has gone down for you since it started?

 

[chamferman]

Just wanting to clarify something please. Did you have fluctuations before taking this drug ie did it go up or down before in noise loudness or was it consistent every day? Is this the first time that it has gone down for you since it started?

I have always had fluctuations since T started.

 

[amandine]

I have always had fluctuations since T started.

thank you for replying. So sadly we dont know if the lower 5 that you have reported is the drug or the fluctuation.
So we wait for your further reports.
Thank you for keeping up the reports.

 

[Rube]

A quick update for 4th day on trial

Only effect I have experienced that could be considered a side effect, is I have been feeling quite tired the last couple of days, but that could be just down to life in general.

Tinnitus loudness yesterday was an 8/10 and today woke up to a 5/10.

Thanks for the update. It might be too early to answer these questions but when you have some more days on the drug under your belt maybe you can have a better idea.
Aside from the tiredness, have you felt anything else, such as is your t fluctuating more, less or same. Are you seeing higher levels of fluctuation on the drug? Was this 8 to 5 a normal fluctuation for you?