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

[Christian78]

I apologize for my ignorance, I need to understand one thing; in clinical trials why the drug is administered for only 28 days? Why so much time passes between one phase and the next?
Thanks all

They consider that time they need is 4 weeks, to see is there or no effect. Dr told me that they might had to twitch first formula to try to make it better. Why so much time is because they are really slow and also they need to collect data work it and publish it to state openly.

 

[Christian78]

yeeeeeeeeeeeeah!!!

ALL IN PRISON in special rooms full of speakers that emit tinnitus!!!

if you seen statistics... 15% here has severe tinnitus, rest can habituate, so yes trt will work on most, and if we say people who have lower t tend not to be member here but live their lives then you might understand that percentage of us who are in bad position is very low.

I prefer our government give us help to live ok 2 year where we sign contract to die after.

check

Tinnitus Talk Mini Survey Results

 

[john2012]

can anybody guess the earliest we are optimisitcally likely to hear any feeback from the autifony trials?
NOT from official figures but from individuals on the trial who post their progress

for example if some trialee's tinnitus diasppeared, he or she might post it here
to let us know.

 

[dan]

can anybody guess the earliest we are optimisitcally likely to hear any feeback from the autifony trials?
NOT from official figures but from individuals on the trial who post their progress

for example if some trialee's tinnitus diasppeared, he or she might post it here
to let us know.

24 hours.

 

[john2012]

next question...
how may people do we know on the trials,
inculding other forums?
is there any way to increase the number of trial responders on forums?

 

[chamferman]

Day 8 update
(Started trial) Thursday 8/10

Friday 5/10

Saturday 8/10

Sunday 5/10

Monday 8/10

Tuesday 5/10

Wednesday 5/10

Thursday 8/10


The above are my T loudness scores since starting trial . At this moment in time I couldn't tell you whether my T has improved or not. I blame that on being partly on being habituated which means to me that I naturally now do not monitor my T.

I have no definite side effects to report Only thing I could say mention, at work today I was being a bit dumb and I couldn't remember the name of something, I was also suffering with a little bit of short term memory loss, but that could be how I am on occasions anyway.

Sorry I cannot be any clearer and like I said before my T fluctuates. I guess what I am hoping is that there are more consistent 5/10 and below rather than 8/10 by a long shot so I can say there is a notable difference to my T.

 

[Rube]

Day 8 update
(Started trial) Thursday 8/10

Friday 5/10

Saturday 8/10

Sunday 5/10

Monday 8/10

Tuesday 5/10

Wednesday 5/10

Thursday 8/10


The above are my T loudness scores since starting trial . At this moment in time I couldn't tell you whether my T has improved or not. I blame that on being partly on being habituated which means to me that I naturally now do not monitor my T.

I have no definite side effects to report Only thing I could say mention, at work today I was being a bit dumb and I couldn't remember the name of something, I was also suffering with a little bit of short term memory loss, but that could be how I am on occasions anyway.

Sorry I cannot be any clearer and like I said before my T fluctuates. I guess what I am hoping is that there are more consistent 5/10 and below rather than 8/10 by a long shot so I can say there is a notable difference to my T.

Thanks for updating us! Please keep the updates coming.
have you gone back for any checkup or evaluation yet?

 

[chamferman]

Thanks for updating us! Please keep the updates coming.
have you gone back for any checkup or evaluation yet?

No problem, sorry I didn't have better news, half way through the trial you do a telephone check-up and on the last day of trial you have a check up at the hospital which is when you take last dose of drugs

 

[Hotspur]

Hi guys, just back from a ten hour train journey!I started the trial today,found out that participants will not be informed at any point as to what they received
I also asked the doctor if this was a lifetime treatment,the opinion was that it was a four week treatment,but this was purely based on the mice experiment,ive asked if Autifony are able to offer any comfirmation one way or the other,if i notice any difference in the next few weeks i,ll let you know

 

[Rube]

Hi guys, just back from a ten hour train journey!I started the trial today,found out that participants will not be informed at any point as to what they received
I also asked the doctor if this was a lifetime treatment,the opinion was that it was a four week treatment,but this was purely based on the mice experiment,ive asked if Autifony are able to offer any comfirmation one way or the other,if i notice any difference in the next few weeks i,ll let you know

Great news! Hope you find relief, please keep us updated.

 

[amandine]

Hi guys, just back from a ten hour train journey!I started the trial today,found out that participants will not be informed at any point as to what they received
I also asked the doctor if this was a lifetime treatment,the opinion was that it was a four week treatment,but this was purely based on the mice experiment,ive asked if Autifony are able to offer any comfirmation one way or the other,if i notice any difference in the next few weeks i,ll let you know

Just wondered what tests you went through? IE Did you get a hearing test and if yes what hearing loss was required to get onto trial? Other tests? Would be great if you could please specify what hoops you had to jump through to get going on this trial to know whether it is worth trying to get on or not for others........thanks ever so much

 

[Hotspur]

Just wondered what tests you went through? IE Did you get a hearing test and if yes what hearing loss was required to get onto trial? Other tests? Would be great if you could please specify what hoops you had to jump through to get going on this trial to know whether it is worth trying to get on or not for others........thanks ever so much

Hi amandine,i was the first patient at Birmingham,so i think how the course ran was new to everyone there
It was decided that i would do the two stages in the one visit,maybe because i fitted the hearing criteria?It also helped as im quite a long way from the site,tests performed were blood pressure,urine sample,blood test, ECG and of course hearing test
Now my hearing loss reads from low frequency 250hz 20db through to high frequency 6000 hz 48db ,i was told by the audiologist these readings are what he would expect of someone of about 60,im 42,anway hope this helps,i do feel its worth applying doesnt seem quite as rigourous as i thought, but that may simply be due to the hearing requirements,hope it works out for you,bye for now

 

[Champ]

Hi guys, just back from a ten hour train journey!I started the trial today,found out that participants will not be informed at any point as to what they received
I also asked the doctor if this was a lifetime treatment,the opinion was that it was a four week treatment,but this was purely based on the mice experiment,ive asked if Autifony are able to offer any comfirmation one way or the other,if i notice any difference in the next few weeks i,ll let you know

They won't even tell you after the trial if you received a placebo or not? Seems... pointless to me.

 

[Shaun]

hi, just to let you know I did not make it on to trial I passed the initial basic tests and filled in a questionnaire on anxiety and depression which according to the doctor were all ok In order to get on.
I did not pass On the hearing tests as apparently my hearing was ok and I did not have enough hearing loss.
It seems that unless you have adequate hearing loss you won't get a placement.
I might be wrong on this if your t is really high and you are suicidal might a different story mine fluctuates from 2 to 5,but was through the roof when I got home last night typical...I am gutted for a number of reasons but remaining positive.

 

[john2012]

Day 8 update
(Started trial) Thursday 8/10

Friday 5/10

Saturday 8/10

Sunday 5/10

Monday 8/10

Tuesday 5/10

Wednesday 5/10

Thursday 8/10


The above are my T loudness scores since starting trial . At this moment in time I couldn't tell you whether my T has improved or not..

it's possible you've just got the placebo.
we're much hoping to see great things with aut63
at the moment, trobalt is yielding better results!

 

[Hudson]

it's possible you've just got the placebo.
we're much hoping to see great things with aut63
at the moment, trobalt is yielding better results!

I don't think it's a good idea to gleam too much information from really early data. As you have said, he may be getting placebo. It may also take a good deal of time for the active drug to reach high enough concentrations in the blood to have an effect. There are a lot of factors. None of us really know the pharmokinetic profile of AUT00063. All we know is that it is a "potassium channel modulator". It could have a radically different drug profile than trobalt all together. We just don't know.

 

[Christian78]

Day 8 update
(Started trial) Thursday 8/10

Friday 5/10

Saturday 8/10

Sunday 5/10

Monday 8/10

Tuesday 5/10

Wednesday 5/10

Thursday 8/10


The above are my T loudness scores since starting trial . At this moment in time I couldn't tell you whether my T has improved or not. I blame that on being partly on being habituated which means to me that I naturally now do not monitor my T.

I have no definite side effects to report Only thing I could say mention, at work today I was being a bit dumb and I couldn't remember the name of something, I was also suffering with a little bit of short term memory loss, but that could be how I am on occasions anyway.

Sorry I cannot be any clearer and like I said before my T fluctuates. I guess what I am hoping is that there are more consistent 5/10 and below rather than 8/10 by a long shot so I can say there is a notable difference to my T.

same problems caused trobalt, hard to remember word, numbness, loss of short term memory

 

[john2012]

I guess we are all waiting for feedback from an autifony trial
where the person says "yeah, it nuked my tinnitus"
...something definite like that would be nice
(we have had this with trobalt...see dannyboy)

 

[amandine]

I guess we are all waiting for feedback from an autifony trial
where the person says "yeah, it nuked my tinnitus"
...something definite like that would be nice
(we have had this with trobalt...see dannyboy)

John with respect, you keep saying that Danny Boy is a huge success. Well he may be and I certainly hope so! But I would remind you that he is still taking trobalt at 1200mg per day, every day.
If he keeps a supply then hopefully he will continue to be fine....even if he runs out he may still be okay as it may be permanantly gone or incredibly low.
However we dont know this and neither does he.
So there is no great success story here yet...............we and he sit and wait to see what happens if and when he stops taking this very strong drug.
Equally we must sit and wait to see what happens with autifony. As @Hudson said, these things can take a while to work on the brain....

 

[locoyeti]

I don't think it's a good idea to gleam too much information from really early data. As you have said, he may be getting placebo. It may also take a good deal of time for the active drug to reach high enough concentrations in the blood to have an effect. There are a lot of factors. None of us really know the pharmokinetic profile of AUT00063. All we know is that it is a "potassium channel modulator". It could have a radically different drug profile than trobalt all together. We just don't know.

i agree. too soon to tell.

one thing that might be possible is that they are going to give a weak dose for this trial round. i remember for AM-101 they gave the first round of people only 0.27 mg/mL, and perhaps only in one ear if i remember correctly. it was only in the most recent phase of testing that they included the 0.81 mg/mL dosage and allowed both ears to be injected. i think something similar might happen with this early round of AUT63, perhaps they are going slow and cautious with the dosage testing. this might temper our expectations a bit for the better?

 

[Danny Boy]

Tried to get on and this is what they said to me-

Dear Daniel,
I asked our Audiologist to review your previous hearing test. Your hearing is actually very good and therefore you wouldn't be eligible to take part in the QUIET trial with the levels you currently have.
If you feel that your hearing has dropped since you were seen here it might be worthwhile getting a repeat hearing test done closer to home.
Please feel free to email if you have any further queries.

Then I said this-
That's ok. Will the hearing component be abolished in the future? Also someone told me that you are testing to see if the drug may potentially deteriorate hearing? Just thinking wouldn't that be best tested on people with good hearing like me? Anyhow, would love to be on the trial, so do let me know if the hearing component goes away


Dear Daniel,



It's definitely something that's being looked into. We don't know yet whether the hearing loss requirement will be removed completely or whether they will change the level / frequency of hearing loss required. We won't know this until sometime after March.



Because otological conditions, especially high-frequency hearing loss, present one of the major risk factors for tinnitus, the condition is often deemed to reflect neural changes in the central auditory system in response to hearing impairment. This is the first drug specifically developed to treat the central ('neural') component of tinnitus. This is why they are currently looking at patients with some level of hearing loss.



In previous studies there didn't appear to be any effect on the patient's hearing during the trial although with this trial they will looking at the effect of repeated dosing on the hearing which is different to previous studies.



I hope this info is helpful.

 

[Tinnitus Talk]

Recent events have saddened us; members shouldn't question other members' integrity so casually without backing up their accusations with substantial evidence.

Let's all show some respect to the people who are on their free time reporting about their experiences with the trial.

Any further offending posts will be deleted and members appropriately warned or banned.

It's a good time to remind everyone of our Netiquette:
https://www.tinnitustalk.com/threads/netiquette-of-tinnitus-talk.1070/

The discussion may now continue regarding the AUT63 Phase II trial. Please stay on topic.

Thank you. We are all in this together.

 

[Rube]

hi, just to let you know I did not make it on to trial I passed the initial basic tests and filled in a questionnaire on anxiety and depression which according to the doctor were all ok In order to get on.
I did not pass On the hearing tests as apparently my hearing was ok and I did not have enough hearing loss.
It seems that unless you have adequate hearing loss you won't get a placement.
I might be wrong on this if your t is really high and you are suicidal might a different story mine fluctuates from 2 to 5,but was through the roof when I got home last night typical...I am gutted for a number of reasons but remaining positive.

I'm sorry you didn't get on the trial, I hope you are ok
Did they mention if they might include you in the future in the event they relax the hearing loss requirements?

 

[Rube]

Hi amandine,i was the first patient at Birmingham,so i think how the course ran was new to everyone there
It was decided that i would do the two stages in the one visit,maybe because i fitted the hearing criteria?It also helped as im quite a long way from the site,tests performed were blood pressure,urine sample,blood test, ECG and of course hearing test
Now my hearing loss reads from low frequency 250hz 20db through to high frequency 6000 hz 48db ,i was told by the audiologist these readings are what he would expect of someone of about 60,im 42,anway hope this helps,i do feel its worth applying doesnt seem quite as rigourous as i thought, but that may simply be due to the hearing requirements,hope it works out for you,bye for now

I hope you are finding relief, Please update us with your progress..thanks !

 

[Hotspur]

I hope you are finding relief, Please update us with your progress..thanks !

Hi Rube,ive had quite a good day today,its only Day 4 so really difficult to say what thats down to!Im sure you understand with the nature of this, but will let you know in due course,thanks for the interest,hope your doing well,bye for now

 

[Rube]

Hi Rube,ive had quite a good day today,its only Day 4 so really difficult to say what thats down to!Im sure you understand with the nature of this, but will let you know in due course,thanks for the interest,hope your doing well,bye for now

Understood, thanks!

 

[DebInAustralia]

Thank you to all autifony trial participants sharing your experiences with us.

 

[tshapiro]

Thank you to the trial participants who are taking the time to update the tt community

 

[joejunior]

Given that its a double blind placebo trial it would be difficult to make conclusions based on individual results, guess it might be possible to draw loose conclusions with a large enough sample size if there was a clear demarcation in results, with caveats, is it possible to recruit paticipants and have a simple questionaire

 

[iAzra]

When can we expect results from this phase?