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

Dan are you being serious or pessimistic?
If it takes them a year to announce phase 3 then we may have something in about 10 years

 

I am being optimistic.
I'll remind that Phase 1 was announced on June 4th, 2013 and results were announced in April 10th, 2014.
So that's about 11 months. Keep in mind phase 1 was 60 participants at 1 site, so much less work logistically than phase 2 is going to be. So I'm being optimistic.
However, I highly doubt its gonna take 10 years to get to market (or available to the public) because my gut feeling tells me its going to be another year until phase 2 completion and around 2 years for phase 3 completion (including UK regulatory approvals), for a total of.....3 years until phase 4 starts - at which point it will be open to any sufferer to try.

 

@dan
Thank you, sorry I thought you've been sarcastic with the previous post.
3-4 years is not too long but just not sure I will last till then, every day is too much when suffering.
But lets be hopeful!

 

One day at a time @valeri ,
I'm virtually in the same boat as you with hissing T that goes in cycles now, once every two weeks I get a change in tone that is so high pitched it almost seems to disappear for two to three days then returns with a vengeance for a week, then changes tone in one ear for a week just to start the cycle all over again!
Whats worse is I have to wear earplugs for ten hours per day, and the noise! well you can imagine!

So hang in their, all we need to hear next year from Autifony is "Phase 11A was/is a success" and I can wait and exist the couple of years till it's available!

Rich

 

Hang in there love.

 

@dan But aren't they doing Phase 2a now which means a phase 2b as well? Or is this simply phase 2 ?

 

These trials are so short (4 weeks that's unprecedented!) they'll will go very quick, and they don't need a new regulatory approval as in a going into a new phase.

 

Since i'm in the UK this is something I would consider volunteering for.
The 6 months minimum counts me out though. Haven't had it 2 months yet. Hopefully they are still running the trial come January.....

 

Why don't you apply to AM101 Trials? You are still in acute stage:

http://www.aurismedical.com/product-candidates/am-101

 

I agree with @Zechariah . If you want to do a clinical trial now, I would start with the AM-101 trial. You're a perfect candidate. Autifony's compound AUT00063 is meant for more chronic cases, which you don't have for certain yet. If AM-101 doesn't work out, then you can always try Autifony afterwards. They'll be running that trial for a while.

 

I did consider AM-101, but as I am on anti-depressant medication at the moment I believe that would disqualify me from participating?

 

It depends. Were you taking the anti-depressant before you started having tinnitus? If your AD therapy is due to a condition unrelated to your tinnitus, they will allow you to be on the trial. If you are taking the AD because of anxiety/depression induced by the tinnitus... well they won't like that.

 

I hope there's at least a few people on this forum that participate in this phase ii trial. If it starts in October, I hope we can learn how effective it is by the end of the year!

 

One more thing that's not clear to me:
If this trial starts in October and they still haven't got the participants when are they planning to do it all.
I would think that it takes a fair bit of time to go through the selection criteria and pick the right people.

 

Would taking blood pressure medication exclude you from these medical trials

 

Could be mistaken, but I think that the details will be available in October. Yes, the selection process will take a while, plus there will be different sites in the UK holding the trials. So this may take a bit more time. But that's OK.

 

uhhhhhhhhhhhm.

http://www.nhs.uk/Conditions/Tinnit...7-GB&Condition=Tinnitus~quiet&pn=1&Rec=0&CT=0

well here's the inclusion and exclusion data. if i'm reading this correctly...you need to have 20db of hearing loss and less than 60db hearing loss. and you can't be anxious or depressed. and they do an auditory brainstem response at the beginning and end of the treatment which is around 80-85db and quite loud.

well shit!

 

Why would anybody bother to treat their tinnitus if they aren't depressed or anxious about it! wtf

 

"moderate to severe depression or generalized anxiety" yeah if the depression/anxiety was mild you probably either have a great handle on the reaction to your severe tinnitus, or you have mild tinnitus

 

I guess altogether their exclusion criteria excludes ALL members of Tinnitustalk

 

it's a conspiracy. they read this forum and they think we're nuts, and they don't want us within 100 yards of them if we get a placebo...

 

I'm sure they mean clinical depression/anxiety. Everybody has bad days. And "general anxiety" would mean you're anxious about everything. If you're anxious only about your tinnitus, it's not general anxiety.

Great find @mmacabre! We know from this that at least two visits are mandatory, and the dosage of the study medication is 800mg. The pills are therefore 200mg each, as they mention on the study site that they're meant to be taken 4 at a time once per day. That's an interesting contrast with retigabine, which has so far appeared effective at higher doses spaced evenly throughout the day. We also have detail on the hearing loss qualification that we did not have before. We knew an average before, but now we have the exact values they'll be checking - 250, 500, 1000, 2000, and 4000Hz - for that 20-60db threshhold.

Pretty sure I qualify, if only I could get across the pond! For those hoping to get into the study, the most important part of the whole page is this:

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 102
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

So 152 total subjects. Pretty small sample size. Get 'em while they're hot, folks!

EDIT: I'm emailing Ms De Wolf now about non-UK participants. Will post if I get a response. I politely suggest we not flood her inbox.

 

Here you go, get yourself a job working on the AUT063 trial.
Its a fixed term contract until May 2016, could that be the end date of trials, just a thought ?

 

Thanks for the link
profoundly deaf in one ear, normal hearing in the other for my age, might still have chance of qualifying.

 

Meh, well that sucks, I don't have hearing loss (atleast not in normal audiogram) so no trials for me. But if the AUT00063 works on people with hearing loss it is more likely to work on people who don't.

Btw, it would be horrible if you get louder T from those auditory brainstem response tests and in the end the medicine doesn't even work for you or generally

 

May 2016? Could it really take that long to conduct a 4 week trial with only 152 patients?

 

Maybe for Phase 2a +b?

Or maybe even for phase 3 too? (wishful thinking)

 

I was so ready to participate in this trial. But according to the criteria, don't match the hearing loss needed at listed frequencies, as my hearing shows as normal at those levels. Plus tapering a benzo right now re drug interactions.
If anybody does decide to participate, please please keep us informed.
Have no idea when these trials start?
Really looking forward to hearing about the results.
Still hopeful.

 

this is exciting news. my questions are the hearing loss required for inclusion into the trial, why is that a requirement?
how is the the TFI score measured?
pending results of the trial, it is possible the 4 week dosage could be extended?

 

just my two cents, failing a tonal hearing loss test is quite easy, don't push the button after your hear the frequency and that'll be considered hearing loss.