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

Discussion in 'Research News' started by attheedgeofscience, Sep 19, 2014.

    1. valeri

      valeri Member Benefactor Hall of Fame

      Location:
      Australia
      Tinnitus Since:
      09/2011
      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:(
       
    2. dan
      Chatty

      dan Member

      Tinnitus Since:
      06/2011
      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.
       
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    3. valeri

      valeri Member Benefactor Hall of Fame

      Location:
      Australia
      Tinnitus Since:
      09/2011
      @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!
       
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    4. RichL
      Inspired

      RichL Member Benefactor

      Location:
      Palmerston North NZ
      Tinnitus Since:
      1990
      Cause of Tinnitus:
      Acoustic trauma
      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
       
      • Like Like x 1
    5. dan
      Chatty

      dan Member

      Tinnitus Since:
      06/2011
      Hang in there love.
       
    6. Stina
      Psychedelic

      Stina Member Benefactor

      Location:
      Tartu
      Tinnitus Since:
      11/13
      @dan But aren't they doing Phase 2a now which means a phase 2b as well? Or is this simply phase 2 ?
       
    7. dan
      Chatty

      dan Member

      Tinnitus Since:
      06/2011
      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.
       
    8. eldudebro
      Doh

      eldudebro Member

      Location:
      Glasgow, United Kingdom
      Tinnitus Since:
      31/07/2014
      Cause of Tinnitus:
      Acoustic Trauma/Loud Music.
      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.....
       
      • Hug Hug x 1
    9. Zechariah

      Zechariah Member Benefactor

      Location:
      Finland
      Tinnitus Since:
      05/2014
      Cause of Tinnitus:
      Acoustic Trauma
      Why don't you apply to AM101 Trials? You are still in acute stage:

      http://www.aurismedical.com/product-candidates/am-101
       
      • Agree Agree x 1
    10. Hudson
      Cowboy

      Hudson Member Benefactor

      Tinnitus Since:
      2003
      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.
       
      • Agree Agree x 1
    11. eldudebro
      Doh

      eldudebro Member

      Location:
      Glasgow, United Kingdom
      Tinnitus Since:
      31/07/2014
      Cause of Tinnitus:
      Acoustic Trauma/Loud Music.
      I did consider AM-101, but as I am on anti-depressant medication at the moment I believe that would disqualify me from participating?
       
    12. Hudson
      Cowboy

      Hudson Member Benefactor

      Tinnitus Since:
      2003
      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. :)
       
    13. earsnothappy

      earsnothappy Member

      Tinnitus Since:
      May 2014
      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!
       
    14. valeri

      valeri Member Benefactor Hall of Fame

      Location:
      Australia
      Tinnitus Since:
      09/2011
      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.
       
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    15. mcgregor

      mcgregor Member Benefactor

      Location:
      Scotland
      Tinnitus Since:
      10/2013
      Would taking blood pressure medication exclude you from these medical trials
       
    16. Lisa88

      Lisa88 Member

      Tinnitus Since:
      11/2013
      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.
       
    17. mmacabre
      Ape-like

      mmacabre Member

      Tinnitus Since:
      2011
      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!
       
      • Informative Informative x 1
    18. dan
      Chatty

      dan Member

      Tinnitus Since:
      06/2011
      Why would anybody bother to treat their tinnitus if they aren't depressed or anxious about it! wtf
       
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    19. mmacabre
      Ape-like

      mmacabre Member

      Tinnitus Since:
      2011
      "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
       
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    20. dan
      Chatty

      dan Member

      Tinnitus Since:
      06/2011
      I guess altogether their exclusion criteria excludes ALL members of Tinnitustalk
       
    21. mmacabre
      Ape-like

      mmacabre Member

      Tinnitus Since:
      2011
      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...
       
      • Agree Agree x 1
    22. rtwombly
      Bookworm

      rtwombly Member

      Location:
      Southeast USA
      Tinnitus Since:
      01/2014
      Cause of Tinnitus:
      Unknown
      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.
       
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    23. 111

      111 Member

      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 ?
       

      Attached Files:

      • Like Like x 1
    24. mcgregor

      mcgregor Member Benefactor

      Location:
      Scotland
      Tinnitus Since:
      10/2013
      Thanks for the link
      profoundly deaf in one ear, normal hearing in the other for my age, might still have chance of qualifying.
       
    25. Zechariah

      Zechariah Member Benefactor

      Location:
      Finland
      Tinnitus Since:
      05/2014
      Cause of Tinnitus:
      Acoustic Trauma
      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 :banghead:
       
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    26. lapidus

      lapidus Member Benefactor

      Location:
      Sweden
      Tinnitus Since:
      1999
      Cause of Tinnitus:
      Noise induced
      May 2016? Could it really take that long to conduct a 4 week trial with only 152 patients?
       
    27. Philip83
      Jaded

      Philip83 Member Benefactor

      Location:
      Swede living in Austria
      Tinnitus Since:
      2001
      Cause of Tinnitus:
      Noise trauma from loud moped (2001) Noise blast (2014)
      Maybe for Phase 2a +b?

      Or maybe even for phase 3 too? :D (wishful thinking)
       
    28. Lisa88

      Lisa88 Member

      Tinnitus Since:
      11/2013
      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.
       
    29. Rube
      Fine

      Rube Member Benefactor

      Location:
      USA
      Tinnitus Since:
      7/2014
      Cause of Tinnitus:
      Loud shit
      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?
       
    30. Valentin

      Valentin Member

      Location:
      Thailand
      Tinnitus Since:
      17/08/2013
      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.
       

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