If AM101 fails and results are not sufficient to get the approval from FDA then it will really difficult for Auris Medical to put money on other T research. They invested more than 30 millions USD for the clinical phase 3. As a consequence it will be a really hopeless for all of us. That is a mess.
AM-101 Clinical Trial — Participants Updates and Discussion
- Thread starter NewGuy
- Start date
MemberI agree hopeful1. And perhaps within the first weeks (one or two weeks , not month(s)!) since onset. I am then really suprised about the T severity results already published in 2014 showing 65% people with much improved/very much improved compared to the placebo with 35%.
That is because people simply quit the trial when it does not work and improved people stick with the trial....that messes up the stats..as the people..i think this is the secret behind success of AM 101
That is because people simply quit the trial when it does not work and improved people stick with the trial....that messes up the stats..as the people..i think this is the secret behind success of AM 101
Do you have any source on this?
I know atleast one person who quit in this forum after having 1 set ot injections out of 3 sets in open label....especially for the 2nd trial.
I believe they should not include open label data in the trial.
But don't they still do a followup interview when they quit the program? I don't think one person really gives any kind of indication on how they are conducting the clinical trial.
My logic what is the motivation to attend all the followup appointments when they think it is not working? Especially for open label..when you know you got the medicine and it did not work.
They should NOT be including open label trial in the results which they do....and that is the problem with results.
If you dont attend all the followups ... your data is not included in the results.
Then how would that be skewing the data if it's not included in the results?
I'm not sure how TACTT 2 worked but TACTT 3 and AMPACT are two different studies, they aren't including the open label in the results of the double blind study. They are separate studies.
I was told I'm free to quit the trial whenever I wanted, but I would need to come in for a final visit whenever I did. That way they could wrap it up there and do a final questionnaire etc. I don't think they just exclude people that end early, but it probably depends on why they exit the trial early.
Simple... people for whom it worked are happy and continue...and people who are not happy quit the trial ......no way they can include people who quit as regular diary is mandatory and with out that data ... and without proof that they are not taking other medications..if they include them the study will be invalid.
I have read tons on am 101 and read people are excluded if they quit in one of the papers released by AM....no where they tell you they separated open label from double blind results ... i think they just add the results to am 101 group as they is no control for open label.
Like I said TACTT 2 and AMPACT (the open label) are completely different studies. Maybe it's different in Europe, but I doubt it. You finish the double blind study then are rolled over into AMPACT. It is a separate study and the results of the two are not mixed together. I don't know about the phase II trials as I was not a part of that.
Tim Hogan
Member
- Jun 30, 2016
- 57
- Tinnitus Since
- June 2016
- Cause of Tinnitus
- Flu Virus >>Middle Ear Test >>> Ear Infection/Medication
Is there anyway to get the AM-101 Injections (UK), or was it stickly a reserved Trial that has stopped?
My (New?) Tinnitus is less than a month old and i dont want to wait it out for it to become centralised to my brain.
Does the NHS or even private healthcare offer this treatment if you ask?
My (New?) Tinnitus is less than a month old and i dont want to wait it out for it to become centralised to my brain.
Does the NHS or even private healthcare offer this treatment if you ask?
I believe the licensing process is very rigorous at the final stage and if there are design discrepancies at the least another trial would be required. However at the earlier stages of drug development / testing its more up to the company to decide on what design protocol will give them convincing evidence. I have a number of concerns about the results in the 2014 study, but I think the TACTT 2 and AMPACT will not have exactly the same design and statistical treatment as for a start there were alot more people involved than in the earlier studies so Auris should not be scrabbling around for enough data points like they may have been earlier.
I do think that for most people the process of treatment is a challenge with nearly all having massive spikes etc and this is glossed over in the company literature. If that level of bias exists in interpreting results (eg including or excluding drop-outs) then the short to medium term outlook for this product is questionable. It may get launched if Auris can prove little harm and as there is no other treatment for acute tinnitus but once results from actual clinical use rolls in... thats when the rubber hits the road. In fact the whole measurement based on subjective scoring is to me questionable. I really can't say whether my tinitus is better or worse than before the injections, loud then, loud now. It is only that ambivalance that makes me say it must be the same, but that is not a satisfactory score as any moment is heavily influenced by other distracting factors.
As for me I have to decide whether to do the open label and its a tough one as I dont have any benefit from TACTT2. I would like to know if I had the placebo just before I decide, to make the logical choice, but apparently this info will not be given to me. Ethically I think it should be, most trials tell participants if they had the placebo.
I do think that for most people the process of treatment is a challenge with nearly all having massive spikes etc and this is glossed over in the company literature. If that level of bias exists in interpreting results (eg including or excluding drop-outs) then the short to medium term outlook for this product is questionable. It may get launched if Auris can prove little harm and as there is no other treatment for acute tinnitus but once results from actual clinical use rolls in... thats when the rubber hits the road. In fact the whole measurement based on subjective scoring is to me questionable. I really can't say whether my tinitus is better or worse than before the injections, loud then, loud now. It is only that ambivalance that makes me say it must be the same, but that is not a satisfactory score as any moment is heavily influenced by other distracting factors.
As for me I have to decide whether to do the open label and its a tough one as I dont have any benefit from TACTT2. I would like to know if I had the placebo just before I decide, to make the logical choice, but apparently this info will not be given to me. Ethically I think it should be, most trials tell participants if they had the placebo.
I agree with what you said, but how else would you measure tinnitus? I too have a hard time gauging volume.
MML minimum masking level was the original end point for AM 101..but AM 101 failed to deliver on it...so they changed end point to Tinnitus annoyance.
Auris Medical Gets FDA's Fast Track Designation For Keyzilen In Acute Peripheral Tinnitus
http://finance.yahoo.com/news/auris-medical-gets-fdas-fast-190717223.html
Has this already been posted?
http://finance.yahoo.com/news/auris-medical-gets-fdas-fast-190717223.html
Has this already been posted?
I think it is summer holidays for a lot of us and we may try to give holidays to our T and /or H too.
Good luck to all !
Good luck to all !
No you can also shove a pill through your ear drum which will dissolve inside there.
Ian Mac
Member
- Jun 1, 2016
- 321
- Tinnitus Since
- 2011
- Cause of Tinnitus
- Vestibular Nueritis, loud music (dubstep)
Let us know how it goes! What does open label mean? A different kind of injection? Do you know if your still getting placebo or is everyone getting the real thing now? What have you experienced in regards to your tinnitus so far with am101?
Open label means i get am 101 for sure.
AM 101 caused me ocassional Pulsative Tinnitus and my ears pressure regulation (Eustasion tube) is messed up after procedure.
It probably increased my T reactiveness.
3ri0w
Member
- Nov 25, 2015
- 398
- Tinnitus Since
- 2012, H 2016, 12/2018(?)
- Cause of Tinnitus
- loud noises, ringing came back 12/2018 after 1year of silent
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