AM-101 Clinical Trial — Participants Updates and Discussion
- Thread starter NewGuy
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In my case i would have done all rounds except for the fact that i did not feel any difference other than set back in my habituation. I really think i got placebo the first round where i though i would had really help (2 months since onset). I did like i promise the second round with real drug and felt no real changes from the base line at day 10. I did had hearing loss (not really significant like oddv since it was less than 15 db at some frequencies and i did get hyperacusis in the left ear post second round injections for two weeks which is gone now). I decided not to do the third round since the stress from having hearing loss, (did not had it in the first round), the commitment and going back to base level after second round when i expected a little bit of improvement, was too much for me. I think therefore i will probably be one of the 38 % ( ( At Day 90, mean tinnitus loudness improvement was 48 %; 62 % of patients (unilaterally affected and treated)) reported much or very much improved tinnitus severity, taken form auris page). I know it was a little unfair to them for only waiting about 17 days post injections to start trobalt but it was my desicion and i gave them all the info that they want it for the first round without any cheating or taking any sort of drug, so this second round was solely for me (they get as a trade perfect data for my first round). I did call them and opt out after taking trobalt.
@papu was the hearing loss only a temporary effect of having the gel in your ears? or was it permanent?
@greenpointer it was temporary and also the hyperacusis although a little bit scary (I stressed for two weeks thinking once again if I did wrong in going on with the second round of the trial, the injections were nothing compared to the feeling of having done something to make it worse, but the hearing did come back). Also the loss was more of a subjective thing since 10 to 15 db up or down might not be significant like the 70 db temporary loss that oddv had.
Not to be pessimistic. I read the post. I am aware that some people have reported great improvement, others not so much. Moreover unrepresentative data, involving the reduced sample in relation to the total of people involved in the trial.
What scares me most is the risk of hearing loss arising from any intratimpanic treatment. In the Phase II there reported some cases.
You know something? It would be terrible to use AM 101 to relieve tinnitus and hearing loss experience.
Options are low, but they exist, and scary.
What scares me most is the risk of hearing loss arising from any intratimpanic treatment. In the Phase II there reported some cases.
You know something? It would be terrible to use AM 101 to relieve tinnitus and hearing loss experience.
Options are low, but they exist, and scary.
Yeah but it was temporary.. unless you have data that shows otherwise?
From their fact sheet:
Safety: AM-101 was well tolerated and had no negative impact on hearing. Adverse events were mostly local and procedure-related, as expected. Following i.t. injections, a number of patients experienced a transient increase in tinnitus loudness and muffled hearing. These effects usually resolved with closure of the ear drum (typically a few days post injection) http://www.aurismedical.com/images/auris/downloads/auris_fact_sheet_AM101.pdf
There is a risk of permanent hearing loss, as in any tympanic treatment. The efficacy and safety brochure credits him, as a percentage of 1-3%.
Bring bad news for everyone. I had an interview with the attending physician 101. An assay am really qualified and prepared, very solvent and doctor specialized in this field.
It was conclusive and clear: am 101 does not work for more than 6 months, testing in patients older than 6 months became 12 months and there was no result.
I'm sorry. It was devastating to me. I'm on the floor.
It was conclusive and clear: am 101 does not work for more than 6 months, testing in patients older than 6 months became 12 months and there was no result.
I'm sorry. It was devastating to me. I'm on the floor.
Tests with patients over six months were in use under this doctor. Does anyone know where the results of those tests are?
AM101 is gonna be on market at the end of 2016, so, all people with existing t, and ones that gonna have it in next 6-8 am101 is useless...
The doctor in charge of the project was 101 am clear. Am 101 was tested with tinnitus of more than six months and not worked. Forget chronic 101 am. Maybe in some cases it could lower it, but usually does not have any effect.
The time you take now with tinnitus? The last round they did when you were wearing more than 6 months with tinnitus?
Please, someone tell me where the studies are assayed am 101 tinnitus 6-12 months with negative results? In some items that data is mentioned, but no study is provided.
@Carlos Galiano I don't think anyone has that data yet, aside from Auris Medical. I believe the post-acute segment of the trials were only done in phase 3 (which is still ongoing) so the public won't see that data until they publish the results.
I think it is this that hints that it is not effective after six months:
http://www.the-scientist.com/?articles.view/articleNo/43843/title/The-Sounds-of-Silence
Because it is not known when that transition from ear to brain occurs, one of the current trials, of 300 European patients, is specifically testing tinnitus sufferers who have developed the condition no more than three months prior to treatment. The other, a study of 330 North American patients, is investigating a therapy within one year post-trauma. Preliminary results suggest that S-ketamine is effective beyond three months, but declines in effectiveness within a year of the initial trauma, so later stages of the trial are being refocused on the four- to six-month time frame. The trials will be completed at the end of this year, and Auris hopes to submit to the US Food and Drug Administration (FDA) for approval in the summer of 2016.
http://www.the-scientist.com/?articles.view/articleNo/43843/title/The-Sounds-of-Silence
Because it is not known when that transition from ear to brain occurs, one of the current trials, of 300 European patients, is specifically testing tinnitus sufferers who have developed the condition no more than three months prior to treatment. The other, a study of 330 North American patients, is investigating a therapy within one year post-trauma. Preliminary results suggest that S-ketamine is effective beyond three months, but declines in effectiveness within a year of the initial trauma, so later stages of the trial are being refocused on the four- to six-month time frame. The trials will be completed at the end of this year, and Auris hopes to submit to the US Food and Drug Administration (FDA) for approval in the summer of 2016.
When am101 started with development, about 2011? summer of 2016 is fast market hit, for injection drug...
Lloyd Carter
Member
This article was posted earlier in the thread. This guys seemed to have a very positive outcome but it states that he had T for two years before entering the trials which is obviously a typo. They must mean two months.
http://www.icenimagazine.co.uk/tinnitus-patient-gratefu/
Lloyd Carter
Member
Sounds like that guy improved his H a bit? And got a little, but not total, reduction in his T? Still, I'm yet to see any real reason to try AM-101 unless you're literally on the edge.
There's actually a good handful of improvement stories in this thread. Also on reddit.
@Lloyd Carter quoted one of my posts below.
Also, I've extensively documented my experience of AM101 on this site... I'm a few day over the one year mark and will be doing a success story soon, but I have to say it helped me.
Also, I've extensively documented my experience of AM101 on this site... I'm a few day over the one year mark and will be doing a success story soon, but I have to say it helped me.
Please, I am thinking of entering 101, any participant or another person could contact if there is a risk of permanent hearing loss? The Phase II studies are silent on this issue. Only speak of temporary loss. I am convinced that there is that risk.
As far as i know (and i think i have read all posts) the only hearing loss reported has been temporary, the worst case reported was oddv with a drop to 70 db which he reported was only temporary. Myself i reported a 15 db loss and a little bit of hyperacusis after second round of injections which lasted maybe about 15 to 21 days.
Papu muchas gracias. Yo también he leído todos los mensajes y he obtenido la misma conclusión. Pero eso no significa que no existe tal riesgo, y es algo que me preocupa. El texto de la fase II dijo que "por lo general" o riesgos "típicos" desaparecen cuando el tímpano se cierra. Pero no dice nada específicamente sobre el riesgo de pérdida permanente de la audición. Solo eso. Muchas gracias a todos por sus respuestas.
Se entiende que cualquier tipo de inyección intratimpánica podría causar la pérdida permanente. En el caso de los esteroides menos.
Se entiende que cualquier tipo de inyección intratimpánica podría causar la pérdida permanente. En el caso de los esteroides menos.
Stu
Member
- Apr 12, 2015
- 16
- Tinnitus Since
- 01/04/2015
- Cause of Tinnitus
- Noise Induced Trauma - Concert
I experienced hearing loss too during both my first and second rounds but I can't sress enough that it was temporary.
I won't be going back for a third round as AM-101 has made no difference to my T at all. (IF ANYONE KNOWS OF ANYONE NOT EXPERIENCING ANY IMPROVEMENT UNTIL THE 3RD ROUND THOUGH I'D LIKE TO HEAR ABOUT IT!!!) Having said that I would still recommend giving it a go as it may work for you and you won't be any worse off at least... It's always better to regret something you have done as opposed to something you haven't!
I won't be going back for a third round as AM-101 has made no difference to my T at all. (IF ANYONE KNOWS OF ANYONE NOT EXPERIENCING ANY IMPROVEMENT UNTIL THE 3RD ROUND THOUGH I'D LIKE TO HEAR ABOUT IT!!!) Having said that I would still recommend giving it a go as it may work for you and you won't be any worse off at least... It's always better to regret something you have done as opposed to something you haven't!
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