Autifony Phase II Trial Participants Experiences

[Tinnitus Talk]

Only participants of the Autifony Phase II trial (QUIET-1) are allowed to post in this Experiences thread.

Everything else — including comments on these experiences — related to the QUIET-1 study should go here:
https://www.tinnitustalk.com/thread...-treatment-of-hearing-loss-and-tinnitus.6516/

From the staff of Tinnitus Talk on October 13th, 2015:

Autifony's QUIET-1 study has been terminated due to lack of efficacy.

Read More & Discuss

 

[chamferman]

I signed up for the trial, and I am now on my second day of taking the pills. Will check in to forum and give reports on how I am progressing. My tinnitus loudness level has always varied from day to day. Day one which was last night it spiked but then I was mega tired, out of 10 I would give it an 8. Today since midday it as been a 3 and I have no side effects to report.

 

[chamferman]

Congratulations for having the chance to access to this trial!!!
You say your T varies widely. Is there before the treatment?
Can you tell us the dosage of taking the tablets? At what times of the day? On an empty stomach?
Finally, can you tell us specify as the origin of your tinnitus and sound frequency?
I hope you do not have a placebo and that you will hold us know!
Thank you for your answers and i am crossing every fingers for you!!

Q.You say your T varies widely. Is there before the treatment?
A.Yes T loudness level varied before treatment

Q.Can you tell us the dosage of taking the tablets? At what times of the day? On an empty stomach?
A. 4 x 200mg tablets not on empty stomach, has to be same time every day

Q.Finally, can you tell us specify as the origin of your tinnitus and sound frequency?
A. My T started from a condition called Bells Palsy, but my doctor thinks it could have happened at any time. I am inclined to agree as over the years I have exposed my self to loud noise thorough work and play,sound frequency is around 6kHz.

 

[chamferman]

@chamferman

On your profile it says that you have had T since June 2013. Is there not a time limit to enter these trials and wasn't this from 6 to 18 months? If your T started in June 13 then you would be in your 19th to 20th month now depending when in June 13 it started. Are they then not strict with these time limits or have I got it completely wrong or is June 13 a typo maybe?
Thanks for clarifying

Well spotted it was indeed a typo, End of July was my official T start date, I blame it on my sausage fingers

 

[chamferman]

Excellent thanks for checking In and updating us.
Do you have H also? Any changes with H if you have it?
Did they give you the full months dosage to take home with you?
Did you feel anything at all so far?

Hi Rube
I had H for the first 6 months of T and thankfully it went, they gave me the full dosage, I don't want too say I am feeling the effects of the drugs until I am really sure that I am, if that makes sense.

 

[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.

 

[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.

 

[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.

 

[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. I've 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

 

[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

 

[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

 

[Hotspur]

One Week Update,Hi guys,not much to report so far!The last week its been round about a 4,sometimes a little higher ,sometimes a bit lower, which is roughly how its been for the past year,anything else happens i,ll let you know,bye for now

 

[Hotspur]

Are you feeling any any small side effect?? I think aut must have some side effects even little, somebody knows that??

Hi Juan,no side effects so far!Its a 28 day course so who knows?Hope your enjoying Riga!Bye for now

 

[Hotspur]

I would love to hear what had been accepted as hearing loss and what had been rejected as insufficient hearing loss and which clinic said what.

Hi amandine,i think there is a degree of flexibility regarding the hearing test,looking at a test i had done in my town six months ago,my 20db hearing loss kicks in at 1khz,before that at 250hz and 500hz its 15db
I do remember the NHS audiologist saying she didnt think i would be eligible(at my local hospital)while an independent chap thought this was a bit harsh, as my loss is 20db and worse after 1khz
I assume youve had a hearing test?If not maybe best to have one before applying,hope this helps,bye for now

 

[Hotspur]

You were told that your hearing loss was not sufficient for the trials although sounds pretty bad to me but I know little about the subject. Yet even though you were told this you were still accepted into the trials. Did you have a hearing test done at the trial centre and what requirement did you have to have to be accepted.

Hi amandine,it was an audologist at my local hospitals opinion that i was ineligible,no one to do with the trial
Ive had two hearing tests done at the trial centre,was not told of the requirements ,bye for now

 

[chamferman]

Day 17 update

01) Thursday 8/10 Started trial
02) Friday 5/10
03) Saturday 8/10
04) Sunday 5/10
05) Monday 8/10
06) Tuesday 5/10
07) Wednesday 8/10
08) Thursday 5/10
09) Friday 8/10 Tooth abscess Pain
10) Saturday 8/10 Tooth abscess Pain
11) Sunday 8/10 Tooth abscess Pain
12) Monday 4/10
13) Tuesday 8/10
14) Wednesday 7/10
15) Thursday 7/10
16) Friday 7/10 Root Canal at dentist
17) Saturday 8/10

Sorry for the delay above are my T loudness scores, still no side effects to report.
Wish I could have posted better scores . At the dentist when receiving local anaesthetic my T dropped to a 3 but rose backup shortly afterwards to a 7.

 

[chamferman]

Doesn't sound as effective as trobalt or you've sadly got placebo, which it must likely sounds like you do.

it's not over until the fat lady sings!

 

[chamferman]

Well, trobalt worked right away, so I would imagine this drug would've too?

I think its better to judge each individual drug on it own merits, rather than making comparisons.
They both have different compositions do they not?

 

[chamferman]

Still, I think you're on a placebo. It couldn't just work on the 28th day only?

Who knows what's going to happen we will just have to wait and see

 

[Hotspur]

Hi guys,just been speaking to someone running the trial,this drug will be open to people with T longer than 18 months!The course will be longer!Hope thats made someones day!

 

[Hotspur]

What do you mean that the course will be longer? Do you mean that they are going to carry the trials on for longer than they initially said ie to the summertime 2015 ? or do you mean that people are going to be taking the pills for longer than 4 weeks? and do you know anything about the hearing test getting easier or not? and the person you got this from is someone reliable who knows what he or she is saying? the person is actually in charge of running the trial? thanks

Hi amandine,yes the person is someone from the hospital,who is in direct communication with the doctor from Autifony
Just been chatting about my course and try getting to get a bit more info!
This is supposed to give relief within four weeks for people between 6 to 18 months,if you have it longer,the course will be more than four weeks

 

[Hotspur]

I live in germany can I participate in anyway in a trial? Have T now for lets say 17 Months.
So when it hits the market is probably had T for lets say 5 Years, would it than still be effective? (of course we not know)

But when I read about aut00063 the idea was to give anyone relief of T through hearing loss or noise damage, isn't'it?

Hi robb,im not sure,at a guess,if someones had it 18 months and the course is 4 weeks,maybe if youve had it 36 months the course is 8 weeks?

 

[Hotspur]

I should also mention communication between Autifony and the hospital has not been great!
For anybody else doing this its 4x200 with breakfast!Hopefully chamerfans doing it right!
When i started,i was handed ONE pill and told taking with food not nessacary,i then presumed it would be One pill every 4 hours during the day,really thought it could have been quite easy to write directions on the bottle!
Anyway Autifony doctor doesnt think its too much of an issue ,and im now doing it the correct way!

 

[Hotspur]

Is this drug supposed to be a cure to completely eliminate tinnitus?
If this drug were successful would it be taken as a suppressant that must be taken for life?
Are we doomed to not have any relief if we have had tinnitus for more than 18 months?
Also, if this drug was proven to be effective, how long before it goes onto the market?
Has a human subject with tinnitus ever taken this drug during its development and had relief?

Hi Mark,the nurse i spoke to this afternoon was reading out the information sent to the hospital from Autifony
Relief from T after a 4 week course for those between 6 to 18 months,a longer a course for those with longer T
I suppose the definition of relief is now trying to be ascertained by the trial

 

[Hotspur]

Hotspur, is there any change in your tinnitus yet?how long have you been taking it now a week or two? hopefully you will send us good news soon!

Hi jeannie,still tricky to say,im not half way into the course yet ,usually im about a 4,have had a few recent days of about 2,but had those without this,not sure what everyones definition of a 2 is?For me its being in a quiet room but still hearing it quite faintly but it not bothering you too much? Hope this helps

 

[Hotspur]

@Hotspur

Thanks for the updates and your attempts to get as much info as possible. Its great to have a TT correspondent on the inside.

Hi mate thats no problem,it all seems quite open when you chat on the phone,hope i dont get a knock on the door from Autifony heavies in the middle of the night!

 

[Hotspur]

@Hotspur
Thank you also for updating us. Much appreciated.
Your T seems to be quite low anyway but it seems to have gone down a bit.
Did you see or enquire yet what the hearing criteria is or will be as you seem to have low T so I think that you also have minor hearing loss too......? maybe....

Hi amandine,ive always found trying to rate T a bit vague!Surely one mans 4 is another mans 8?I tend to hear it over the tv and radio on bad days,dont it hear it so much when im at work

The most accurate gauge ive found is Audionotch Tuner,mine measured 12khz which im told is quite high,wish the NHS would use this site, as seems to match much better than what ive come across in hospitals!
Dont think i have minor hearing loss,as im 42 and been told i have the hearing of someone between 60 to 65
As for their criteria,always thought you had to have 20db loss across most frequencies?I had that, apart from 250 hz and 500 hz where i had about 18db

 

[Hotspur]

Thank you for the updates. Are you feeling any side effects or something that can be perceived as a side effect of the drug? I wonder If the trial hospital would give you any info on any of the other trialees? Might be worth a shot to ask!

Hi Rube ,no side effects at all,i was thinking as my hearing was quite bad ,one way of seeing if any effect has taken place ,would be too see the results of the hearing test when i go back

 

[Hotspur]

Hi Rube ,no side effects at all,i was thinking as my hearing was quite bad ,one way of seeing if any effect has taken place ,would be too see the results of the hearing test when i go back

Hope now you might see something now that you are taking the one larger dose per day.

Thanks for that,quite disapointing really,think communication would be better,although autifony doctor didnt seem to think it was a big deal