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

[amandine]

I would love to take part in the trials in London .How do you apply or volunteer .

Minimum of six months T before u can go on the trial so ..........

 

[Rube]

I wonder how our trialees are doing?
@Hotspur and @chamferman how are you doing?

 

[Rube]

It looks like details of Autifony's trial for hearing loss only (CLARITY- 1) in the U.S, have just been released

https://clinicaltrials.gov/ct2/show/NCT02345031

I just noticed this USA trial for hearing loss is 3 tabs for a total of 600mg of aut00063 daily.

 

[Rube]

I emailed one of the trial doctors for the USA aut00063 trial for age related hearing loss CLARITY-1 to see if they will be doing the QUIET-1 study. Here is the response:

"Thanks for inquiring about the clinical trials for age related hearing loss. The trials for tinnitus are still in the planning stages for the US. It is my understanding that there is a plan to open the trials here but I do not know when that will be.
Feel free to contact me in the future to inquire about possible future clinical trials."

 

[Dubbyaman]

Why does it seem like theyre making more effort towards t over seas then here in the states?

 

[Mark662]

Why does it seem like theyre making more effort towards t over seas then here in the states?

There's research going on in a number of countries, including much in the US, but nothing so far has come out of it to help us. Autifony is ongoing, but the individuals on the trial who are forum members haven't had any positive effects at this time or are not reporting back.

 

[erik]

Why does it seem like theyre making more effort towards t over seas then here in the states?

In general, it is a less complicated process to conduct research and clinicals in Europe than the U.S. Furthermore, EU has recently made major changes in legislation to improve research transparency (must publish summary within a year), improve competition and make the findings accessible to the public.

http://www.biomedcentral.com/biome/...ion-spell-for-the-future-of-medical-research/

 

[Viktor Salvatore]

Hotspur. You very well may be changing the Tinnitus horizon ...just the hope you bring is already doing that. Please be alert to your changes and take note of ups and downs. If this was Vegas, I would put my money on you.

 

[jeannie]

Hotspur, have you had any changes in tinnitus yet? and what day are you on now?? thanks.

 

[Juan Carlos]

@jeannie , i think he and the other got placebo, that was 25% chance. Both dont feel absolutely nothing on T or side effects. I just cant believe if was the real drug would feel absolutely nothing, they must be almost in the complete month. Hope they can confirm us soon if the got placebo or not. Unluckily maybe we will have to wait to July to see results

 

[James White]

Isn't placebo more around 45% ?

 

[nills]

Isn't placebo more around 45% ?

1 getting placebo is 50/50 chance .. 2 of them is 25 percent chance. The more people taking the drug the less chance all of them get placebo, the higher the chance they get the real drug.

 

[Philip83]

1 getting placebo is 50/50 chance .. 2 of them is 25 percent chance. The more people taking the drug the less chance all of them get placebo, the higher the chance they get the real drug.

Good old probability theory. The human brain seems to just be crap at it, and I'm certainly no exception

 

[nills]

actually it is true, it does n`t make any sense that there is more chance of having the drug than the placebo when there was a 50/50 at the start ... ok, anyone with a mathematical brain that can theoretically explain? (you see, i`m more the right hemisphere of language and nonsense)

 

[Mo_Mo]

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...

@attheedgeofscience had done the probability calculation using a mathematical model previously for the % of placebo users

 

[jeannie]

ok thanks juan....

 

[Philip83]

actually it is true, it does n`t make any sense that there is more chance of having the drug than the placebo when there was a 50/50 at the start ... ok, anyone with a mathematical brain that can theoretically explain? (you see, i`m more the right hemisphere of language and nonsense)

It does, but keep in mind there's only 25% chance that both got the drug too it's a 50% chance that one is on drug, and one is on placebo.

DD 25%
DP 25%
PD 25%
PP 25%

Which should leave us at a 75% chance that one of them is getting the real deal.

 

[Lisa88]

Haven't been on this thread for a while. Thanks to @Hotspur and @chamferman for keeping us posted. I encourage other participants to keep us in the loop too, despite the naysaying and speculative posts on this thread (so many of which I have had to scan through), it helps the rest of us to keep our hopes up. Cheers.

 

[chamferman]

Day 1 (5/10)
Day 2 (8/10)
Day 3 (5/10)
Day 4 (8/10)
Day 5 (5/10)
Day 6 (8/10)
Day 7 (5/10)
Day 8 (8/10)
Day 9 (8/10)
Day 10 (8/10)
Day 11 (4/10)
Day 12 (8/10)
Day 13 (7/10)
Day 14 (7/10)
Day 15 (3/10)
Day 16 (8/10)
Day 17 (6/10)
Day 18 (8/10)
Day 19 (6/10)
Day 20 (5/10)
Day 21 (7/10)
Day 22 (8/10)
Day 23 (5/10)
Day 24 (5/10)
Day 25 (8/10)
Day 26 (7/10)
Day 27 (5/10)

These are my total T loudness scores for the trial. I have decided to keep a score of my T for the next 4 weeks for a comparison. Being as I am the first person to carry out the trial at the hospital, the nurse who is running the trial had no other info regarding results.

My hearing was checked after trial and there was no difference in results from when it was checked before trial.

Looking back over trial period there were no real side effects to report. If I was on the real drug maybe I should feel side effects coming off?

 

[RCP1]

Thanks @chamferman I think you definitely had the placebo. Thanks for taking part in the trial - It as a selfless thing to do in the retrospective context of you getting no overall benefit.. Lets hope it wasn't the drug !!! If it was goodnight Irene ... However I think it unlikely. Thanks again for keeping us posted.

 

[Carlos1]

@chamferman I just wanted to say thanks also ....God I hope it was the placebo

 

[nills]

you know what we should do? print some nice poster of TinnitusTalk and put them up in the participating clinics ... saying something like ... participating with Autifony ? ... come and share your experiences and get free masking sounds and hugs and medals and alot of likes from your pals at tinnitustalk!

 

[Mark662]

you know what we should do? print some nice poster of TinnitusTalk and put them up in the participating clinics ... saying something like ... participating with Autifony ? ... come and share your experiences and get free masking sounds and hugs and medals and alot of likes from your pals at tinnitustalk!

...and the chance to win ear plugs in a Facebook contest! ...and I thought it was a tasteless joke

 

[Remington]

Hello everyone. Is anyone having my same side effects as slow digestion, constipation, dry mouth, headache, confusion? Is possible that a placebo give side effects?
Thanks!

 

[Markku]

Hello everyone. Is anyone having my same side effects as slow digestion, constipation, dry mouth, headache, confusion? Is possible that a placebo give side effects?
Thanks!

Are you in the Autifony trial too?

Exciting! Welcome to Tinnitus Talk.

 

[Remington]

Hallo Mark! Yes i'm on trial but if it don't give some positive results i will abandone. Does anyone know what are the side effects of a placebo? The doctors do not say anything. They only say: "write your questionnaire and if you feel bad call us". I've done a lot of tests before enrollment, EEG even ... I'm a bit sad.
Thank you

 

[RCP1]

Hi @Remington ,

Welcome to Tinnitus Talk. You may not now it but right now you are the most important individual on the board.
You are on the Autifony trial and it sounds like you have the actual drug.

Sorry to hear about the side effects - These may pass in a few days.

How long have you been taking the drug ? How many days in?

Don't forget you may only need 28 days dosage full stop for a recovery... It would probably be worth those side effects you mention if it reduced your T longterm after 28 days of putting up with the effects..?

Very best of luck. Wishing you all the best and some sort of remission.

R

 

[Sharpfire]

Hallo Mark! Yes i'm on trial but if it don't give some positive results i will abandone. Does anyone know what are the side effects of a placebo? The doctors do not say anything. They only say: "write your questionnaire and if you feel bad call us". I've done a lot of tests before enrollment, EEG even ... I'm a bit sad.
Thank you

Placebo's can give side effects but it's very unlikely. Chances are that you have the real drug.

 

[lapidus]

Is placebo in trials always "sugar pills" or can the placebo be another drug (that is harmless but can give some side effects) ?

 

[amandine]

Hello everyone. Is anyone having my same side effects as slow digestion, constipation, dry mouth, headache, confusion? Is possible that a placebo give side effects?
Thanks!

Just wanted to add that these are all symptoms of great stress too. Wondering if you are stressed about doing the trials or for any other reason?
Otherwise I would say that you are having the real drug which was developed by the same person Dr. Large who developed Trobalt. This drug Trobalt is being trialed here by members of this forum with some great results but some side effects. Then Dr Large developed the Autifony drug especially for Tinnitus to lower or cure T but with no or few side effects.

I can see that you are just on 18 / 19 months 'ish since your start of T so their 6 to 18 months is indeed a bit flexible....your T started in July 2013....
Please can you tell us, if it is ok with you, how is your hearing and what kind of hearing tests you had to take?
Do you know what loss of hearing they are looking for (aside from what is written on their website as it seems this may differ in practice from trial clinic to clinic).
This info would be incredibly useful for other people to get the oomph to apply to be on trials.
How long have you been on the trial so far and have you noticed any difference in your T levels yet?
We are all so looking forward to hearing your info......thank you so much for posting and please would you answer the above questions. It is incredibly appreciated by all of us.
Thank you!