Audion Therapeutics Trial

Discussion in 'Research News' started by Aaron123, May 20, 2017.

    1. JohnAdams
      In love

      JohnAdams Member Benefactor Hall of Fame

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      Wait isnt this about Regain?
       
    2. Mathieulh
      No Mood

      Mathieulh Member Benefactor

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      Tinnitus Since:
      05/24/2019
      Cause of Tinnitus:
      Chronic headphones use and acute noise induced trauma.
      You are resurrecting an old post of mine, but as far as I recall, this was about Trobalt's replacement.
       
    3. JohnAdams
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      JohnAdams Member Benefactor Hall of Fame

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      Aspirin Toxicity/Possibly Noise
      No, the first post in this thread is about the use of gamma secretase inhibitors to regenerate hair cells, therefore this thread is about Regain.
       
      • Agree Agree x 2
    4. zhiyuan
      Depressed

      zhiyuan Member Podcast Patron Benefactor

      Location:
      China
      Tinnitus Since:
      03/2019
      Cause of Tinnitus:
      sudden hearing loss
      Has anyone seen the papers related about gamma secrete inhibitor, like this:

      https://www.ncbi.nlm.nih.gov/pubmed/23312516

      From this paper I find the drug works much better at the apex area of the cochlear than the base. I am afraid Regain may not be efficient for high frequency hearing loss.
       
    5. JohnAdams
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      JohnAdams Member Benefactor Hall of Fame

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      My only argument to that is that mice have a much much faster heart rate and metabolism. There is a circulation in the cochlear fluids, and maybe with mice as soon as the drug is injected it is quickly accumulated in the apex whereas humans, with larger cochleas and a slower metabolism, it may settle in the base more so. There are many variables.
       
      • Agree Agree x 1
      • Informative Informative x 1
    6. FGG

      FGG Member Podcast Patron Benefactor

      Tinnitus Since:
      01/2019
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      Multi-factorial
      If this found to be the case, it would be good to have drugs that affect the base better and drugs that affect the apex better. More people would be covered.
       
    7. JohnAdams
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      JohnAdams Member Benefactor Hall of Fame

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      What is it?
       
    8. Dizzyhead888

      Dizzyhead888 Member Benefactor

      Tinnitus Since:
      2015
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      unknown
      Do we have patients here that participated in phase 1? What were the outcomes on tinnitus, hyperacusis and hearing loss?
       
    9. JohnAdams
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      JohnAdams Member Benefactor Hall of Fame

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      If there are then they have signed NDA's. The only indication is a second hand anecdote, which I have no reason to doubt, that stated that their tinnitus and hyperacusis did in fact improve and they resumed their lives.
       
      • Informative Informative x 1
    10. Dizzyhead888

      Dizzyhead888 Member Benefactor

      Tinnitus Since:
      2015
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      how many second hand anecdote do we have hear?
       
      • Good Question Good Question x 1
    11. JohnAdams
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      JohnAdams Member Benefactor Hall of Fame

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      1
       
    12. Badger19

      Badger19 Member

      Tinnitus Since:
      2012
      Cause of Tinnitus:
      NIHL
      Remember that phase 1 tests the safety of the drug. Usually it is tested on healthy adults.
       
      • Agree Agree x 1
    13. Dizzyhead888

      Dizzyhead888 Member Benefactor

      Tinnitus Since:
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      Yes, it tests safety, but still people can benefit. Phase 2 would be just adjusting doses to evaluate efficacy.

      It's sad we don't have the participants from this trial or Frequency Thereupatics here...
       
    14. JohnAdams
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      JohnAdams Member Benefactor Hall of Fame

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      Lol we might.
       
    15. Badger19

      Badger19 Member

      Tinnitus Since:
      2012
      Cause of Tinnitus:
      NIHL
      Phase 1 is tested on healthy individuals: https://en.wikipedia.org/wiki/Phases_of_clinical_research

      Unless this trial was an exception, they don't even check efficacy.
       
    16. JohnAdams
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      JohnAdams Member Benefactor Hall of Fame

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      They can test whatever they want but it's the FDA that won't accept efficacy data until phase 2, which in my opinion is a huge waste of time.
       
      • Agree Agree x 1
    17. Badger19

      Badger19 Member

      Tinnitus Since:
      2012
      Cause of Tinnitus:
      NIHL
      They can't test efficacy while they use the drug on healthy people. Again, unless this trial was an exception.
       
    18. JohnAdams
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      JohnAdams Member Benefactor Hall of Fame

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      So you're saying that they tested phase 1 on people without hearing loss?
       
    19. ajc

      ajc Member

      Tinnitus Since:
      11/2002; spike 2009; worse 2017-18
      Cause of Tinnitus:
      Loud music - noise damage
      No. They tested on people with hearing loss.

      http://www.isrctn.com/ISRCTN59733689

      Who can participate?
      Adults aged 18 to 80 who have hearing loss.
       
      • Agree Agree x 1
    20. JohnAdams
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      JohnAdams Member Benefactor Hall of Fame

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      So then why can't they test the drug's efficacy and safety in phase 1 for any other reason than government rules?
       
    21. ajc

      ajc Member

      Tinnitus Since:
      11/2002; spike 2009; worse 2017-18
      Cause of Tinnitus:
      Loud music - noise damage
      This is taken from a cancer website but applies to tinnitus and hearing loss too.

      Phase 1 is sometimes written as phase I. They are usually small trials, recruiting only a few patients. The trial may be open to people with any type of advanced cancer, usually those who have already had all other available treatments.

      Phase 1 trials aim to find out:
      • how much of the drug is safe to give
      • what the side effects are
      • how the body gets rid the of drug
      • if the treatment helps shrink the cancer
      Patients are recruited very slowly onto phase 1 trials. So even though they don't recruit many people, they can take a long time to complete.

      They are often dose escalation studies. This means that the first few patients that take part (called a cohort or group) are given a very small dose of the drug. If all goes well, the next group have a slightly higher dose. The dose is gradually increased with each group. The researchers monitor the side effects people have and how they feel, until they find the best dose.

      In a phase 1 trial you may have lots of blood tests because the researchers look at how your body copes with and gets rid of the drug. They carefully record any side effects you may have and when you have them.

      The main aim of phase 1 trials is to find out about doses and side effects. They need to do this first, before testing the potential new treatment to see if it works. Some people taking part may benefit from the new treatment, but many won't.
       
      • Informative Informative x 1
    22. JohnAdams
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      JohnAdams Member Benefactor Hall of Fame

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      So why can't they test the safety, and then take the exact same people and test their hearing?
       
      • Good Question Good Question x 1
    23. Badger19

      Badger19 Member

      Tinnitus Since:
      2012
      Cause of Tinnitus:
      NIHL
      Normally phase 1 is tested on people who don't have the condition that the drug aims to treat. Again, it tests for safety of the drug. But this does seem to be an exception to that rule.
       
    24. JohnAdams
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      JohnAdams Member Benefactor Hall of Fame

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      So then they should be able to combine this study with phase 2 and shorten their trial review time.
       
      • Agree Agree x 1
    25. Badger19

      Badger19 Member

      Tinnitus Since:
      2012
      Cause of Tinnitus:
      NIHL
      Ask the FDA :rockingbanana:
       
    26. Jackjohnson183

      Jackjohnson183 Member Benefactor

      Tinnitus Since:
      2017
      Cause of Tinnitus:
      Ear wax removal
      @síocháin has replied to my message and she has let me know that she contacted the mutual friend to find out more. He basically did not state whether his tinnitus and hyperacusis had improved, only that he is doing better now and he can go on tour again. If it did not improve the likelihood of him going back on tour is quite low. Whether he was injected in one or both ears @síocháin does not know. I would assume it would have been in one ear.

      I wonder if he experienced more improvement in either tinnitus or hyperacusis than the other.

      But that’s all I got so far from @síocháin. Maybe when they are more relaxed on NDA he might be willing to talk more about it.
       

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