AM-101 Clinical Trial — Participants Updates and Discussion

Discussion in 'Research News' started by NewGuy, Oct 21, 2014.

    1. OddV
      Assassinator

      OddV Member Benefactor

      Location:
      USA
      Tinnitus Since:
      09/2014
      Cause of Tinnitus:
      Ear Infection
      I did have catastrophic hearing loss up around 8 kHz after my first injection of the real stuff... Doctor asked me to skip a day... I was back to my baseline by the 3rd day.

      I have to echo @NewGuy's sentiment... "I would rather live knowing I tried than live regretting that I didn't do anything when I had the chance."
       
      • Agree Agree x 1
    2. Romain B.

      Romain B. Member

      Tinnitus Since:
      10/2014
      @NewGuy
      @OddV

      I have to give you a BIG THX !! You made my day..
      It's perfectly how i see it deep inside me :
      "I would rather live knowing I tried than live regretting that I didn't do anything when I had the chance."
      It's just what i needed.. some people to bring it back to the surface..
      Read those words from someone else has shut my inquiries down and comfort me in the decision to do it.. there is no way to have regret plus T in your head to remind you that you had maybe a chance to keep it quieter.

      Definitely thanks to have pointed out this kind of reflexion that in an unconscious way i was looking for.

      No way to live with regret and the "if i had.."

      big thanks both of you.

      Hope the third set of injections will give you more relief.. and silence !!
       
    3. tomm
      Thinking

      tomm Member Benefactor

      Location:
      London, UK
      Tinnitus Since:
      10/2014
      Cause of Tinnitus:
      Acoustic trauma (club drumming)
      @Romain B.

      Spike for 2 weeks, then moderately quieter than before. I'll be doing all three further rounds.
       
      • Hug Hug x 1
      • Informative Informative x 1
    4. tomm
      Thinking

      tomm Member Benefactor

      Location:
      London, UK
      Tinnitus Since:
      10/2014
      Cause of Tinnitus:
      Acoustic trauma (club drumming)
      I was eating very large quantities of vit-D3 for 3 months. Didn't do much, although I know nerves take time to grow.
       
    5. amandine

      amandine Member

      Tinnitus Since:
      july 2014
      No sorry I didnt explain myself well - sorry. I mean when you said that in that case it should work on chronic cases according to what Grandfunk1 said.
      I didnt understand that bit....why it should work on chronic sufferers in that case...
       
    6. chase.j

      chase.j Member

      Tinnitus Since:
      1-25-15
      I am all for what that doc said but it is much different than what Auris medical says "who is the manufacturer of AM-101": Acoustic trauma and other insults to the inner ear may trigger increased levels of extra-cellular glutamate, which in turn cause excessive activation of cochlear NMDA receptors. This process results in damage or killing of sensory cells and is thought to be responsible for abnormal spontaneous "firing" of auditory nerves, which may be perceived as tinnitus. Under normal circumstances, the NMDA receptors are thought to play no role in fast excitatory neurotransmission, respectively normal hearing. AM-101 is blocking cochlear NMDA receptors to suppress the aberrant excitation of the auditory nerve that is perceived as tinnitus.
       
    7. Romain B.

      Romain B. Member

      Tinnitus Since:
      10/2014
      @tomm

      Big Thx for the quick answer and your feelings regarding Am-101 !! it's giving me confidence .. I will stick to the am-101 ship to sail on that T sea during the next months !! Thx
       
    8. skoupidis

      skoupidis Member

      Tinnitus Since:
      09/2014
      Cause of Tinnitus:
      Acoustic trauma or mvc
      So, after a shot with the real thing you feel better, the T is lower and you habituate? Waiting your report after the 3rd shot (when will that be?).
       
    9. skoupidis

      skoupidis Member

      Tinnitus Since:
      09/2014
      Cause of Tinnitus:
      Acoustic trauma or mvc
      Well, here is your answer:
      After the period they consider to be 6 months, the tinnitus becomes chronic, that is the nerve fibers cannot reattach. And the AM-101 is to suppress their firing...
      I cannot explain it much further, according to these, AM-101 is for chronic sufferers!
      Unless there is more to it that meets the eye, or grandfunk1 misunderstood them.
       
    10. grandfunk1

      grandfunk1 Member

      I hope i understood him right and gave you guys the right information. He did say there was a window of time for AM-101 so i dont know if that meant it gets burnt in the brain or something else happens, i dont know.
       
    11. Sharpfire
      No Mood

      Sharpfire Member

      Location:
      London
      Tinnitus Since:
      12/2014
      Cause of Tinnitus:
      Unknown
      How did you guys sign up for the trial? I registered on the website weeks ago but haven't heard back since. Should I just give them a call?
       
    12. skoupidis

      skoupidis Member

      Tinnitus Since:
      09/2014
      Cause of Tinnitus:
      Acoustic trauma or mvc
      You didn't mention this before, from what you said before, no window was mentioned. How much time is it?
      How do they know about the window? Did they tested the drug for long time patients?

      I guess we can only wait, these are really important questions and I don't know even if they are able to answer right now.
       
    13. OddV
      Assassinator

      OddV Member Benefactor

      Location:
      USA
      Tinnitus Since:
      09/2014
      Cause of Tinnitus:
      Ear Infection
      3rd set would be end of May. Yes, I feel better after the real thing... I've experienced a few moments of complete silence, alas, they haven't "stuck".

      I would be remiss if I didn't mention this to those of you getting ready to sit in the chair for the first time.

      1) 1st set...take someone with you... After the first set you'll be able to do it on your own
      2) take a stress ball (use it during injections)
      3) take a travel pillow (lay your head on it during injections... You've got to lay there a while)
      4) take entertainment (tablet, phone, book, computer, something to help you pass the time, you're going to be in "your" clinic for a while)
      5) breath in through your mouth and out through your nose... Control your breathing... It's over quickly... The "thought" of it is worse than the reality

      Not trying to scare anyone, but just some tips I wish someone had given me before I went the first time.
       
      • Helpful Helpful x 3
      • Informative Informative x 1
    14. Romain B.

      Romain B. Member

      Tinnitus Since:
      10/2014
      @Sharpfire

      You must give them a call at the location nearby you !! ask for a rendezvous ! email them etc.. just don't wait an answer ! Call buddy call !
       
    15. Romain B.

      Romain B. Member

      Tinnitus Since:
      10/2014
      @OddV

      Thx for the tips !! i was also thinking to take a pillow to keep the head down, to not loose one sip of this drug !! Much more confortable i guess !!
       
    16. Sharpfire
      No Mood

      Sharpfire Member

      Location:
      London
      Tinnitus Since:
      12/2014
      Cause of Tinnitus:
      Unknown
      Seems like I've been accepted on to the trial after calling them. Will keep this thread updated with progress.
       
    17. OddV
      Assassinator

      OddV Member Benefactor

      Location:
      USA
      Tinnitus Since:
      09/2014
      Cause of Tinnitus:
      Ear Infection
      My last follow up for the 2nd set of injections is on April 28th. I've let the clinic know that I'm 70% likely to do the 3rd set. My coordinator is setting up those injections for April 28th, 29th, and 30th.

      My T is not gone, but I'm able to handle it much much better. It is lower, I think I'd rate it at this point a 3 or a 4. I've had a few days of high annoyance, but I know that those days I was very stressed, which is a definite trigger for me.
       
      • Informative Informative x 1
    18. Joel86

      Joel86 Member

      Tinnitus Since:
      03/2015
      I've had T for one week now. It came on in my right ear as a mechanical buzzing but then shifted into a high pitch squeal the next day. The very next day, I woke up with the same mechanical buzzing in my left ear and now it has shifted to a squeal as well. It's constant. I'm now tapering off Prednisone and still taking antibiotics. Someone told me to check out AM-101 and there is a trial place only a few miles from me. They're ready to screen me and do injections, but I'm pretty nervous about it. I'm already a hypochondriac, and I know that it won't be a comfortable procedure, and no gaurantee I'll even get the drug for the first 90 days, or that I'll ever know that I did. With the emotional state I'm in already about my T, I would hate to make it worse with a few more days of worsening T or hearing loss. I haven't even seen an ENT yet. Should I wait to do the trial for another month or so and see how my T progresses?
       
    19. Rube
      Fine

      Rube Member Benefactor

      Location:
      U.S.A
      Tinnitus Since:
      7/2014
      They accept applicants up to 90 days after T onset, maybe you might want to wait a few weeks to see if it resolves on its own. Additionally if you don't get the drug during the actual trial they will give you the actual drug afterwards. I can't give any advice to help you decide but maybe some of the participants can or you can read through the thread and the participant experience thread.
       
    20. OddV
      Assassinator

      OddV Member Benefactor

      Location:
      USA
      Tinnitus Since:
      09/2014
      Cause of Tinnitus:
      Ear Infection
      @Joel86 do you know what caused your T? They'll want to know.

      If I had know then what I know now, I would have tried to get on the trial earlier.

      Once you go for screening, you have to wait two weeks prior to injections... So, go to the screening and then you have 2 weeks to make up your mind to see if it gets better.

      My $0.02.
       
      • Agree Agree x 1
    21. Joel86

      Joel86 Member

      Tinnitus Since:
      03/2015
      I don't know for sure what caused my T but my gp treated me for an ear infection and saw fluid behind the ear drum.
       
    22. NiNyu

      NiNyu Member

      Tinnitus Since:
      29/12/2014
      Cause of Tinnitus:
      barotrauma? stress?
      Then I wouldn't do it. Getting injected through the tympanic membrane with a placebo.. is a no-go for me.
       
    23. OddV
      Assassinator

      OddV Member Benefactor

      Location:
      USA
      Tinnitus Since:
      09/2014
      Cause of Tinnitus:
      Ear Infection
      But you're guaranteed the drug after the initial injection.... 10 seconds of pain vs. a chance that it works for you.

      I've sat in the chair... Yes, the unknown can be scary, but an injection through the tympanic membrane is not something new... They've been doing it for a long time.

      Don't discourage him from going to the screening just because a shot sounds scary. I've had 6 now and will probably end up with 12 within a year by the time I'm done.
       
      • Agree Agree x 2
    24. skoupidis

      skoupidis Member

      Tinnitus Since:
      09/2014
      Cause of Tinnitus:
      Acoustic trauma or mvc
      That's a lot of shots. How many of them was the real drug for certain?
       
    25. OddV
      Assassinator

      OddV Member Benefactor

      Location:
      USA
      Tinnitus Since:
      09/2014
      Cause of Tinnitus:
      Ear Infection
      Everything after the first 3 is guaranteed real drug.
       
      • Helpful Helpful x 1
    26. skoupidis

      skoupidis Member

      Tinnitus Since:
      09/2014
      Cause of Tinnitus:
      Acoustic trauma or mvc
      I hope you do see real improvement and go upto 12 to eleminate your T if possible. Isn't that a lot for the eardrum to take? Will it heal properly?
       
      • Good Question Good Question x 1
    27. OddV
      Assassinator

      OddV Member Benefactor

      Location:
      USA
      Tinnitus Since:
      09/2014
      Cause of Tinnitus:
      Ear Infection
      Ear drum was fully healed at the 7 day check up
       
      • Helpful Helpful x 1
    28. NiNyu

      NiNyu Member

      Tinnitus Since:
      29/12/2014
      Cause of Tinnitus:
      barotrauma? stress?
      Time is of the essence here!

      That being said, injecting through the eardrum is an invasive treatment considering you might end up with nothing. A placebo. Personally, I think they should have conducted this study without placebo. They would have attracted way more participants. Of course, with pills it's a different story.
       
    29. OddV
      Assassinator

      OddV Member Benefactor

      Location:
      USA
      Tinnitus Since:
      09/2014
      Cause of Tinnitus:
      Ear Infection
      1st, they are attracting participants despite the fact that it is an injection. Their biggest challenge is the inclusion criteria. There is a very small subset of tinnitus sufferers that can even get on the trial. I suspect that @Joel86 might meet that criteria, which is why I encouraged him, at a minimum, to go to the screening session. There is no commitment to getting the injections by going.

      2nd, this is how a drug trial works... Having a placebo... It helps prove that the drug does or does not work.

      Lastly, there is MORE than enough information in this thread, if anyone bothers reading it from the beginning, to make an informed decision for themselves to participate.
       
      • Agree Agree x 1
    30. Danny Boy
      Cheerful

      Danny Boy Member Benefactor Hall of Fame

      Location:
      England
      Tinnitus Since:
      7/2014
      Cause of Tinnitus:
      Ear infection
      Well, AM-102 is basically pills, so go figure lol
       
      • Funny Funny x 1

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