AM-101 TACTT1 Results Released
- Thread starter Hudson
- Start date
Member- Jul 21, 2013
- 842
- Tinnitus Since
- 01/2013
- Cause of Tinnitus
- Acoustic trauma from headphones
Have tinnitus, be close enough, and be in the acute stages.
Also need to know where it is but I don't know that =)
Also need to know where it is but I don't know that =)
You can check clinicaltrials.gov, they have the Auris Medical trials listed in there if you simply search for tinnitus and filter by "Active" trials.
As I said earlier... the acute stage trial available in the United States does not start until December. They have not specified a day that it will start either. The post acute stage trial will only be available in the European Union as far as I know.
As I said earlier... the acute stage trial available in the United States does not start until December. They have not specified a day that it will start either. The post acute stage trial will only be available in the European Union as far as I know.
What if this turns out to be very effectice for EVERYONE? Isn't that a possibility?
There are stories of people getting rid of tinnitus after 2 years etc, then why shouldn't it be possible?
There are stories of people getting rid of tinnitus after 2 years etc, then why shouldn't it be possible?
But let's hope that this IS the magic cure eventhough you have to take it daily or what so ever!
FounderTreatment of Acute Peripheral Tinnitus Following Traumatic Cochlear Injury or Otitis Media - Full Text View - ClinicalTrials.gov
Estimated Enrollment: 330
Study Start Date: December 2013
Estimated Study Completion Date: June 2015
And for those who have successfully completed the TACTT2 Study:
AM-101 in the Post-Acute Treatment of Peripheral Tinnitus 1 - Full Text View - ClinicalTrials.gov
Estimated Enrollment: 330
Study Start Date: February 2014
Estimated Study Completion Date: November 2016
I don't wish to be a downer here, but I think we should all maintain guarded optimism with regards to this. While I have heard good things about AM-101, it is by no means a sealed deal yet.
In theory, a drug in clinical trials should "establish" it's efficacy in Phase II clinical trials. It appears that Auris has achieved this with their recent results that were released. However, it is not unheard of for a drug to fail in Phase III clinical trials (neramexane did). It is my personal belief that the folks at Auris and the professionals they are collaborating with are well aware of this possibility and are working to minimize any of the statistical risks associated with conducting a Phase III trial. Hopefully it works well (it would be great if it is shown to help people that have a more "chronic" case of tinnitus). I think that we should prepare ourselves for the possibility that it is only efficacious for those with early onset tinnitus (which is most likely why they are testing at that stage anyway). The FDA then may approve the drug's use (assuming the trial goes well) for only a certain window of time.
Let's not be overly optimistic about what this may achieve, as it most likely will not be some kind of miracle cure. It may provide relief for a large portion of people though, which would be awesome.
In theory, a drug in clinical trials should "establish" it's efficacy in Phase II clinical trials. It appears that Auris has achieved this with their recent results that were released. However, it is not unheard of for a drug to fail in Phase III clinical trials (neramexane did). It is my personal belief that the folks at Auris and the professionals they are collaborating with are well aware of this possibility and are working to minimize any of the statistical risks associated with conducting a Phase III trial. Hopefully it works well (it would be great if it is shown to help people that have a more "chronic" case of tinnitus). I think that we should prepare ourselves for the possibility that it is only efficacious for those with early onset tinnitus (which is most likely why they are testing at that stage anyway). The FDA then may approve the drug's use (assuming the trial goes well) for only a certain window of time.
Let's not be overly optimistic about what this may achieve, as it most likely will not be some kind of miracle cure. It may provide relief for a large portion of people though, which would be awesome.
- May 20, 2013
- 394
- Tinnitus Since
- April 2013
- Cause of Tinnitus
- Maybe loud music. Not sure.
- Jul 21, 2013
- 842
- Tinnitus Since
- 01/2013
- Cause of Tinnitus
- Acoustic trauma from headphones
I've heard of people having blaring tinnitus for 16 years and then one day their brain is just like "nope its over" and the sound is gone. There's been so many stories of it going away for people at random time intervals that its just hard to know what the answer is. My best advice is to live with it as you would without it and if you have it or it goes away it doesn't impact your goals or your efforts to achieve them.
My dad has had it for 25+ years and is basically fully habituated so maybe I'm screwed (lol) but he's also missing hearing in 1 ear... like 5% hearing... and I have at least 85%+ hearing in both ears so maybe my odds are better.
It went away for my brother, after a couple months. He got hit in the head with a dodgeball and it set off temporary loud tinnitus for several months.
You can never really tell with it, honestly. Mine has days where its annoying the piss out of me then days where its almost serene when its quiet. Who freaking knows.
- Jul 21, 2013
- 842
- Tinnitus Since
- 01/2013
- Cause of Tinnitus
- Acoustic trauma from headphones
If this gets approved for prescription by doctor's, I'd honestly consider giving it a shot with my "chronic" (whatever that means/entails) tinnitus after a couple people with chronic T try it. My doctor would honestly do it for me since she's such a badass...
I won't speculate on what will be appropriate for a drug that is not approved yet, but if it were to occur, I might ask the ENT to give me the treatment as well to see if it does any good. Although, I think I'm beyond help from esketamine though, as I've had tinnitus for a decade now.
I have a theory that masking it 24/7 like i do keeps it from "getting into the brain" or whatever is the distinction between acute and chronic in terms of possible treatments
- Jul 21, 2013
- 842
- Tinnitus Since
- 01/2013
- Cause of Tinnitus
- Acoustic trauma from headphones
You might want to give CR a try. It seems pretty legit for reversing plasticity (i.e., retrain neurons to generate the sound less and develop lower volume tinnitus).
It's unlikely you're going to be going to sleep someday with no sound anytime soon, but it might be so low that you hardly need any masking. Mine is loud at night and I don't mask it but I will wake up with it barely there in the mornings... sometimes...
Randomness feels like its part of it sometimes.
If anyone has an idea of the screening process. Please post their information here regarding AM 101 trials. Do I need my Id when i get there? I am in the phase 3 trial and my wife generally takes care of my stuff due to me having a phscholoigcal problem with memory. Is my physical body enough when i get to the actual study. Or do i need ID to verify who i am and my social security card.
I've been masking my T nonstop for nearly five years with little progress. In fact, my T is most certainly got louder as time passed.
Trust me, brain plasticization has already occurred; it'd be trying to stop a cut from clotting.
I'd just wait until we hear more from the micro transponder next year after the human trials. Without the electrode, I don't see CR being very effective.
- May 20, 2013
- 394
- Tinnitus Since
- April 2013
- Cause of Tinnitus
- Maybe loud music. Not sure.
There will be trial locations in the United States. If you live within travelling distance and you meet the criteria you can participate. You will have to check Home - ClinicalTrials.gov sometime during December when the trial starts for the location information. They don't have any posted yet.
Auris wants you to be a citizen who speaks the native language of the country in which they are administering the trial I believe. You can check their inclusion criteria, I believe it's listed.
Yes, that is the acute trial. From what I can see, they want participants from the acute trial to participate in the "post acute" trial.
- May 20, 2013
- 394
- Tinnitus Since
- April 2013
- Cause of Tinnitus
- Maybe loud music. Not sure.
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