Went for another followup visit last week, no changes to report in Tinnitus volume. I agreed to participate in the followup study, starting 6 Aug.
AM-101 TACTT1 Results Released
- Thread starter Hudson
- Start date
MemberKeep in mind you may very well have received placebo.
It's the sad truth of clinical trials.
SteveToHeal
Member
Hi @Bart Marien. Did you go to the trial? Did they ask you for this report? Is it an exclusion criteria? What if you do not have one?
Ive had tinnitus for about a month and I was contacted today for the research of AM 101. I recently went to the University of Maryland hearing center and they said based on my 2hr hearing tests that I have conductive hearing loss from my middle ear. They recommended another ENT but I don't know what I should do? I only hear my tinnitus in my right ear and only at night. Is this AM101 going to cure it? Has anyone had this drug injected that has actually cured tinnitus??
Ann
The info you have provided is very minimal, so answering is difficult.
Have you spoken to the AM101 trial researchers about your situation? Maybe they can give you some guidance...
If you have a middle ear infection or effusion, then definitely get that looked at first...........
let me know how you go
deb
The info you have provided is very minimal, so answering is difficult.
Have you spoken to the AM101 trial researchers about your situation? Maybe they can give you some guidance...
If you have a middle ear infection or effusion, then definitely get that looked at first...........
let me know how you go
deb
- Aug 14, 2013
- 2,455
- Tinnitus Since
- Resolved since 2016
- Cause of Tinnitus
- Unknown (medication, head injury)
Conductive hearing loss is related to a dysfunction of either the outer or the middle ear. It is a mechanical/structural problem rather than a "nerve"-problem. There is a chance the hearing loss can be reversed.
I don't know why they would recommend another ENT (instead of just dealing with the issue on the spot, themselves). But, there must be a reason, and if you are going to see another specialist, I would perhaps recommend seeing an otologist (instead of an ENT).
Bottomline: you need a diagnosis. It is not enough to conclude that you have conductive hearing loss; it must also be established what is contributing to that hearing loss.
If you had asked me ½-year ago, I would have been quite optimistic about AM101. Auris Medical has done a fantastic job of handling the clinical trials, the info on their website is excellent, and they have been really aggressive in pushing forward with the timeplan. But there appears to be lack of "slam dunk" cases amongst those who have gone through the treatment ie. there - so far - has not been a single person who has come forward saying my tinnitus is gone or massively reduced (to my knowledge). Of course, members on this board could have been unlucky and received the placebo (33%-chance) in all cases (but we all know about the laws of probability). I also had a review of the disclosed phase II trial data with a senior physician at the university hospital of Leipzig; he was not that impressed by the results - "not good enough" to even consider off-label use. Personally, I also find the drug itself lacks "originality". Esketamine has been around for a while for other medical purposes. So it is not as if they are developing a new drug from scratch in order to target a specific problem.
Bottomline: you need a diagnosis for your medical issue. The tinnitus you have may be caused by your conductive hearing loss - or it may be totally unrelated to it. AM101 is designed to fight tinnitus caused by otitis media or noise exposure (ie. damage to the inner ear). If it is deemed that you could be a potential candidate for the clinical trial, I would still consider that possiblity (if I were you). Here's why: the trial is free-of-charge, has a good safety profile, there is a chance you may get better, and the quality of care is really good. So what have you got to lose?
Some of the thing that make me nervous about the AM-101 trial.
(from the list of side effects that StayPositive posted on page 34)
Very frequently reported (more than 10% of subjects reported)
(from the list of side effects that StayPositive posted on page 34)
Very frequently reported (more than 10% of subjects reported)
- Tinnitus louder/worse
- Delayed healing of the eardrum (more than 5 days from last injection)
- Hearing deterioration
- Inflammation of the middle ear or eardrum
- Hearing too loud or distorted
- May 20, 2013
- 394
- Tinnitus Since
- April 2013
- Cause of Tinnitus
- Maybe loud music. Not sure.
just ask yourself if you would have 10 percent of the people joining a trial reporting side effects that GO AWAY in a few days to a few weeks influence your decision to have a possible cure for tinnitus of which 95 % percent of the people that have already had it for numerous years and who knows for the rest of their lives??? you don`t know how fortunate you are and if I could trade places I would give you my T anytime. people wasting time thinking about these minor things while some people suffer enough they would give a limb for it.
If that is the case then the drug will go onto the market in due course anyway. Side effects that dissipate quickly whilst long term benefits persist will be considered appropriately. I think we should respect everyone's personal decisions and concerns. If they can't voice them here without judgement where can they voice them?
I would say that louder tinnitus is a pretty significant thing to consider unless every one on here who has participated in the trial reports that T has subsequently reverted to original levels at best ... In which case bring it on !
- Aug 14, 2013
- 2,455
- Tinnitus Since
- Resolved since 2016
- Cause of Tinnitus
- Unknown (medication, head injury)
Phase I: safety
Phase II: efficacy (usually double blind - if possible).
Phase III: same as phase II but with a larger group of participants
Given that the drug is now in phase III, there isn't too much to worry about. In my opinion.
(And as I have said several times before in some of my earlier posts: if you think safety is only a concern with clinical trials, then think again; people die all the time and/or suffer side-effects from established medical procedures and drugs. From time-to-time, I will read in the news that a certain stem cell treatment has caused the death of a patient. Big News! What people forget is that patients die many, many more times from medical practices which are based on established procedures. But because it is stem cells - something new and "hot topic" - it gets all the attention; never mind all the other people who die constantly. That's minor footnote. Apparently...)
Take care.
Sure every one should voice there opinions, but when I see people throwing away a 1 in a million chance i`m right there to put them on track. the people that I point this out at are those that have it for a month are maybe a few months, i have T for 5 years now... well let`s just say i wish I was in their place... i don`t think you would like me to go along with their fears and say, yes, don`t do it, you might have louder T for a few days, throw away your chance ... why is everything seen as judgment? and if you know a bit about the drug you will know it might only work with tinnitus before 3 months so it very important someone should overcome their little fears as soon as possible and grab hold of the opportunity asap.
There are a few people here on the forum that say the side effects go away (it`s a long thread here but worth the read) I would advice you to contact the study center asap and ask them these questions, I think that will be the best way to give you clarity and courage to go ahead with the trials, best of luck!
The way I see it is that the louder T is caused because of the gel injected into the ear will cause some hearing loss.. muffed sound.. so that means you will have more attention for the T. if you put your finger in your ear your T is also louder. doesn`t mean you have louder T, just meas you hear it louder because you hear less other sounds. that is why they include the louder T in the side effects. As soon as the gel is taken in by the body your hearing returns and all is fine. the gel doesn`t cause damage and doesn`t change brain patterns .. so I really would not worry about it.
@ Nills, I would agree with your suggestion for ENH to contact the people conducting the trials regarding concerns. One would expect that they would be candid about potential outcomes and if the worst case post treatment is 'no change' then absolutely I personally would go for it. Just don't be afraid to ask questions ENH, it's your decision.
Yes people do die or have side effects from established drugs, one of which is chemotherapy, a side effect of which is ... Tinnitus. Considered fairly minor by much of the medical profession, but as many of us know actually also life threatening in its own way. All I am saying is ask your own questions, gather your own info and make your own decision.
Yes people do die or have side effects from established drugs, one of which is chemotherapy, a side effect of which is ... Tinnitus. Considered fairly minor by much of the medical profession, but as many of us know actually also life threatening in its own way. All I am saying is ask your own questions, gather your own info and make your own decision.
- May 20, 2013
- 394
- Tinnitus Since
- April 2013
- Cause of Tinnitus
- Maybe loud music. Not sure.
Have you noticed anything about your Tinnitus levels or anything in particular? How about side-effects?
Thank you in advance.
All of these side effects are transitory in nature according to the safety profile.
Another member has said this here before, and I can't remember who, but the saying went like this: "A drug with no side effects probably has no effects, either."
AM-101 was never billed as a cure. It's billed as a treatment. Since tinnitus is a subjective condition, if they can show statistically significant subjective improvement vs placebo for AM-101, that is a huge step forward in my opinion. Quieter, less intrusive tinnitus elicits often times much less of the emotional and psychological response which causes people to suffer. Would it be cool if it made some peoples' tinnitus more or less go away? Yeah. Is it reasonable to expect that? No. There are very few cures in the world, but tons of treatments. That's just what this is, is a treatment.
For those people who expect a magical cure in the works for Autifony's drug targeting chronic tinnitus, I would say don't hold your breath. What most likely will happen as with anything else is a treatment that is effective.
That may sound disappointing or discouraging, but it's not. It's a huge improvement. There are no known effective treatments for the vast majority of subjective tinnitus cases. I will get behind any treatment that comes out, as it will just increase the knowledge and availability of funds for better and more effective treatments to become available.
If memory serves me, from earlier trials a good indication that you received the active drug was a temporary worsening of tinnitus or slightly distorted hearing.
That was all hearsay though and is not grounded in any way in science.
- May 20, 2013
- 394
- Tinnitus Since
- April 2013
- Cause of Tinnitus
- Maybe loud music. Not sure.
absolutely nothing changed. just the feeling of having my left ear full for a month or so
when are you due to get the real medicin? Looking forward to your feedback after that one cause you might aswell have gotten the placebo last time.
- May 20, 2013
- 394
- Tinnitus Since
- April 2013
- Cause of Tinnitus
- Maybe loud music. Not sure.
Looks like Auris Medical is going to the Nasdaq Stock exchange:
- Auris Medical Holding files for a $86 million IPO
- Auris Medical Holding files for a $86 million IPO
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