Recruiting AM-101 in the Treatment of Acute Tinnitus (TACTT3)

The purpose of this research study is to test the safety and effectiveness of the study drug, AM-101

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    1. Tinnitus Talk
      Balanced

      Tinnitus Talk Knowledge Base

      Tinnitus Talk submitted a new resource:

      AM-101 in the Treatment of Acute Tinnitus 3 (TACTT3) - The purpose of this research study is to test the safety and effectiveness of the study drug, AM-101

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    2. Hudson
      Cowboy

      Hudson Member Benefactor

      Tinnitus Since:
      2003
      http://clinicaltrials.gov/ct2/show/NCT02040194?term=am-101&rank=1

      It looks like Auris has started a new Phase 3 trial for AM-101, and is currently recruiting. This one includes folks who are up to 12 months from onset of their tinnitus. This is pretty exciting! I have no idea about US participation but I think there are many multiple sites in the US that are participating in this though, given what I have heard. Have at it folks, and if you do meet inclusion criteria and you participate, it would be much appreciated if you share your experiences here on TT.

      EDIT: It looks like Auris has multiple Phase 3 trials they are conducting now. This will be an expensive professional effort. My guess is that if they go well, it won't be too long before a drug like this makes it to market after the trials are completed.
       
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    3. Tenna
      Anime

      Tenna Member

      Location:
      Europe
      Tinnitus Since:
      10/2013
      Thats really neat, can someone explain the primary and secondary outcome measures? Im not sure to make of the yays and nays, but dont they seem a bit worrying some of them, or can any conclusions be drawn based on the knowledge leaked? thanks
       
    4. Jake
      Irritated

      Jake Member

      Location:
      Lawrence, KS
      Tinnitus Since:
      07/2013
      After contacting one of the supervising doctors at the University of Kansas Medical Center, I was told that I will be given enrollment information after all of the specifics are worked out. I will keep all of you updated through the process if everything goes as planned.
       
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    5. Hudson
      Cowboy

      Hudson Member Benefactor

      Tinnitus Since:
      2003

      Secondary outcomes are less empirically driven and are more like icing on the cake. You may notice overlap between the primary outcomes and secondary outcomes, with the corresponding secondary outcomes taking place at a later date from the treatment than the primary ones. The primary outcomes engender the most useful and important data for regulatory approval. The secondary ones may be used to supplement safety information or marketing data to the patient.
       
    6. Erlend
      Question it

      Erlend Member Benefactor

      Location:
      Scandinavia
      Tinnitus Since:
      05/2013
      Can you please post the contact information here? There was this one member who was really frustrated as he fits the criteria but he couldn't find the contact information
       
    7. Tenna
      Anime

      Tenna Member

      Location:
      Europe
      Tinnitus Since:
      10/2013
      Mmm icing on cake!.. yeah that was what caught my attention. Information is sparse on those, and one sideffect could vary so much in degree. Lose tinnitus, become deaf? How much deterioration of hearing treshold, what is defined as a (serious) adverse effect? :-O
       
    8. Hudson
      Cowboy

      Hudson Member Benefactor

      Tinnitus Since:
      2003
      You can do like I have done and email different doctors at ENT clinics at universities in your area and ask them if they are participating or if they know of a that is.
       
    9. Amelia
      Daring

      Amelia Member

      Location:
      Australia
      Tinnitus Since:
      08/2013
      I hope I'm reading this right ... But this sounds very exciting! Wish I was in the US now!
       
    10. Hudson
      Cowboy

      Hudson Member Benefactor

      Tinnitus Since:
      2003
      This is a pretty broad clinical trial. I would not be surprised if there were some locations in Aussie land participating :)
       
    11. yonkapin

      yonkapin Member Benefactor

      Location:
      Melbourne, Australia
      Tinnitus Since:
      March 2012
      Awesome news that things are moving along now. The hearing threshold stuff concerns me though.
       
    12. Stina
      Psychedelic

      Stina Member Benefactor

      Location:
      Tartu
      Tinnitus Since:
      11/13
      are you thinking about participating? I think it would be ok for all the EU member probably?
       
    13. frohike
      Approved

      frohike Member Benefactor

      Tinnitus Since:
      06/2009
      Cause of Tinnitus:
      Acoustic trauma
    14. Tenna
      Anime

      Tenna Member

      Location:
      Europe
      Tinnitus Since:
      10/2013
      @Stina arent we all ;) the outcome measures are just of concern to me. Outcome of hearing treshold stated like that can range from almost zero to significant. Also the adverse effects and serious adverse effects hm! troublesome
       
    15. RaZaH
      Not amused

      RaZaH Member Benefactor Team Tech

      Location:
      Reykjavík, Iceland
      Tinnitus Since:
      2012/04
      Cause of Tinnitus:
      Benzo + loud noise
      Hearing Threshold ? Am I missing something ? Are there known sideeffects from this ?
       
    16. Stina
      Psychedelic

      Stina Member Benefactor

      Location:
      Tartu
      Tinnitus Since:
      11/13
      yap it can result in significant hearing loss.
       
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    17. RaZaH
      Not amused

      RaZaH Member Benefactor Team Tech

      Location:
      Reykjavík, Iceland
      Tinnitus Since:
      2012/04
      Cause of Tinnitus:
      Benzo + loud noise
      Eh...ok , nevermind then . :confused:
       
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    18. Stina
      Psychedelic

      Stina Member Benefactor

      Location:
      Tartu
      Tinnitus Since:
      11/13
      Yeah you can get of Tinnitus AND all the other sounds as well! ;)
       
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    19. RaZaH
      Not amused

      RaZaH Member Benefactor Team Tech

      Location:
      Reykjavík, Iceland
      Tinnitus Since:
      2012/04
      Cause of Tinnitus:
      Benzo + loud noise
      I'm good !:thankyousign:
       
    20. Hudson
      Cowboy

      Hudson Member Benefactor

      Tinnitus Since:
      2003
      Do you have any data showing that it has ever resulted in "significant" hearing loss for any individual? The safety studies have shown that:


      "Preliminary results from the TACTT1 study show that both single and triple dose treatments with AM-101 were well tolerated. Occurrence of adverse events or clinically relevant hearing loss overall was low to moderate with no statistically significant differences between treatment groups and dose regimens. As in the previous studies with AM-101, most adverse events were mild or moderate in intensity and represented transient local effects of the injection procedure. At <0.2 ng/mL, the concentrations of AM-101’s active substance and primary metabolite in blood plasma were close to the analytical limits of quantification, thus confirming the minimal systemic exposure offered by the intratympanic approach."

      Thousands of intratympanic injections take place every year. I don't think that it's a given that you will experience a hearing threshold decrease, nor do I think it would be major or permanent if you did. As stated above, most of the adverse events were related to the injection procedure, which heals pretty fast.
       
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    21. Stina
      Psychedelic

      Stina Member Benefactor

      Location:
      Tartu
      Tinnitus Since:
      11/13
      So the hearing loss stated as a threat is probably just a permanent traumatic reaction to the injections?
       
    22. Erlend
      Question it

      Erlend Member Benefactor

      Location:
      Scandinavia
      Tinnitus Since:
      05/2013
      where are you guys getting this from?
       
    23. yonkapin

      yonkapin Member Benefactor

      Location:
      Melbourne, Australia
      Tinnitus Since:
      March 2012
      Thanks for clearing that up!
       
    24. Erlend
      Question it

      Erlend Member Benefactor

      Location:
      Scandinavia
      Tinnitus Since:
      05/2013
      Do you mean temporary? It is normal for the ear drum to burst even if you're just sick sometimes. Happened to my dad when he was a kid. It heals.
       
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    25. Stina
      Psychedelic

      Stina Member Benefactor

      Location:
      Tartu
      Tinnitus Since:
      11/13
      jep meant temporary. Well maybe its worth contacting them and asking whether they will include people from other Eu countries as well. Unlikely but asking couldnt hurt.
       
    26. Grace
      No Mood

      Grace Member

      Tinnitus Since:
      11/14/2013
      Hey all i know this question has been asked on here a thousand times.. But with everyones opinion what do you think the chances of this treatment helping chronic t is...
       
    27. Tenna
      Anime

      Tenna Member

      Location:
      Europe
      Tinnitus Since:
      10/2013
      Phew thanks @Hudson for restoring order :huganimation:
       
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    28. Amelia
      Daring

      Amelia Member

      Location:
      Australia
      Tinnitus Since:
      08/2013
      I will just chime in and say the eardrum doesn't always heal ... My daughter had grommets a few years ago and her ears never healed - we will need to get her her drums patched when she is older.
      It's rare tho.
       
    29. Garden Ring
      Mellow

      Garden Ring Member

      Location:
      Moscow
      Tinnitus Since:
      11/2013
      Cause of Tinnitus:
      Loud concert
      My concern was: if am101 is basically a substance which inhibits transmission of signal from cochlea to the brain to decrease the strength of tinnitus signal, wouldn't it decrease the level if good signal as well?
      It's like removing the whole antenna when you start having statics on your TV.
      But this concern is quite an obvious one, and I guess the guys who develop this treatment are not idiots.

      Still would like an explanation, though.
       
    30. watie

      watie Member

      Location:
      Wichita Kansas
      Tinnitus Since:
      7/2013
      Hay Jake
      Do you have a phone number or other information on how to check on enrollment in the AM 101 study at KU Medical center. I live close to Wichita and my T started about the same time as yours. Thanks for any information you could share.
       

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