I flew on the same day as my treatment. It's fine, albeit a little uncomfortable. So did a few other people that have been in this study. One of the times I was on a flight hours after getting my injections my sinuses immediately cleared out during takeoff, the perforation makes the equalizing easier, but I wonder if that meant the drug did not stay in as long as it should.
AM-101 Clinical Trial — Participants Updates and Discussion
- Thread starter NewGuy
- Start date
I flew on the same day as my treatment. It's fine, albeit a little uncomfortable. So did a few other people that have been in this study. One of the times I was on a flight hours after getting my injections my sinuses immediately cleared out during takeoff, the perforation makes the equalizing easier, but I wonder if that meant the drug did not stay in as long as it should.
gotyoubynuts
Thank you very much for your answer
but how could an injection in the ear works, when the tinnitus is in the brain?
do you know anything about when OTO311 will be on the market?
5 - 10 years
Thank you very much for your answer
but how could an injection in the ear works, when the tinnitus is in the brain?
do you know anything about when OTO311 will be on the market?
5 - 10 years
I am with oddv as I don't visit the site much anymore as I don't dwell on my tinnitus like I use. Tinnitus does get better with time. Yes, it will always be there and you will never find a cure for it. In time your brain will tune it out and it will become background noise. Mine is as loud as the day I got it. The pitch has changed a bit and it went from from multi tone to single tone after a year. I don't cry anymore, and I don't anguish about it like I use to. When I am busy I go hours where I forget about it. When I took the tinnitus handicap test a year ago I scored in the 80's. I took it last week and I scored a 15. Anyone new to this should take the test and hang onto it. Take it again after a year and you will most likely see you have improved.
Any improvement during the AM-101 watch period was negligible and not permanent. There is one take-away we can all agree on, AM-101 doesn't cure tinnitus. We all still have tinnitus after going through the treatment.
Any improvement during the AM-101 watch period was negligible and not permanent. There is one take-away we can all agree on, AM-101 doesn't cure tinnitus. We all still have tinnitus after going through the treatment.
Member- Jan 27, 2016
- 229
- Tinnitus Since
- 01/2016
- Cause of Tinnitus
- Noise induced
Hey guys I just wanted to give a heads up. I skipped my formal 2 months update because I didn't want to jump the gun, and I'm glad that I did. My 2nd month continued really great. Continued having consecutive days of silence, and barely noticing I had T at all. And then 2 weeks ago it just blasted back out of the blue. No noticeable trigger. Just came back fluctuating anywhere from a 1/10 to even as high as 3/10 non stop for the past 2 weeks.
I have no idea what to make of it but it basically caused me to do a complete 180 on my 2nd open label injection. After that 2nd month I was pretty much set on giving it another go, but these past 2 weeks have been a complete setback and truly strange. The last time I have gone a full 2 weeks without a day of silence was back before my initial trial. So I have no idea what to make of this.
I was supposed to call back on monday to tell them whether or not I want to continue. I have postponed doing that until today just to see if this stretch of T was just a fluke and I would get back to the improvement I noticed in the past. Hoping it would get back to silence. Well it didn't happen. I'm a 1/10 today, which really is no improvement for me. So I think I'm going to go ahead and call and tell them I do not want to continue. Thinking with a cool head it's hard to justify another round after this 2 week period I experienced.
I'll post my final update after my final visit, 2 weeks from now, and I hope this is just a fluke.
I have no idea what to make of it but it basically caused me to do a complete 180 on my 2nd open label injection. After that 2nd month I was pretty much set on giving it another go, but these past 2 weeks have been a complete setback and truly strange. The last time I have gone a full 2 weeks without a day of silence was back before my initial trial. So I have no idea what to make of this.
I was supposed to call back on monday to tell them whether or not I want to continue. I have postponed doing that until today just to see if this stretch of T was just a fluke and I would get back to the improvement I noticed in the past. Hoping it would get back to silence. Well it didn't happen. I'm a 1/10 today, which really is no improvement for me. So I think I'm going to go ahead and call and tell them I do not want to continue. Thinking with a cool head it's hard to justify another round after this 2 week period I experienced.
I'll post my final update after my final visit, 2 weeks from now, and I hope this is just a fluke.
Its been maybe nine months since my second round of treatment with AM-101. I can say now it made no change in my tinnitus whatsoever. However my right ear is a little messed up from the treatment, it still pops very loudly whenever I burp. Annoying but nothing awful.
I think the best thing to do is wait until a treatment comes out, until that time look into TRT and habituation of tinnitus, and habituation of perception, playing white noise around the house. These things really, really help.
I think the best thing to do is wait until a treatment comes out, until that time look into TRT and habituation of tinnitus, and habituation of perception, playing white noise around the house. These things really, really help.
For me the only improvement I had was between my T onset end of March and my first injections 2 months and a half ago. I remember one morning at the wake up where I didn't hear my T during several minutes. Since the first injections the T has changed but in the wrong way, it is very intrusive, much louder, fluctuating with a lot of sounds and emotion. Much more difficult to manage and keep me in a nightmare condition. It is really worse. For me AM101 failed, how can you push a drug to the market when there are so bad permanent (? I hope no) side effects (and I think that it is not directly linked to the procedure but the drug itself, according to some reports I had recently from people who had open label with correct procedure). I think that without doing anything after onset except using only basic treatment ( vasodilator and corticoid) the T improves much more over the time that when AM101 is used.
Some friends of mine who had traumatic acoustic event (and some of them twice within few years) were able to manage their tinnitus 6 months after onset and none of them had a worsened condition during this time frame. 2 months after my onset I was considered as mild T sufferring , 2 months and a half ago after AM101 injections (99% sure it was not the placebo) I am severe T suffering. I hope that there will not have a lot of worsening condition among the nearly thousand of participants of the phase 3. I hope that they have not "played" with our human condition only from a business point of view.
Some friends of mine who had traumatic acoustic event (and some of them twice within few years) were able to manage their tinnitus 6 months after onset and none of them had a worsened condition during this time frame. 2 months after my onset I was considered as mild T sufferring , 2 months and a half ago after AM101 injections (99% sure it was not the placebo) I am severe T suffering. I hope that there will not have a lot of worsening condition among the nearly thousand of participants of the phase 3. I hope that they have not "played" with our human condition only from a business point of view.
Hi everyone been a while since I posted I am surprised to see all the doom and gloom on this board. I got my tinnitus from a gun shot, signed up for am 101 and got in just at the end of the window. First round I am almost certain I had placebo no improvement at all. 3 months later had the open label stayed off work for two weeks thought my life was over then I improved dramatically I almost felt cured. Since then it rebounded ever so slightly that I decided last minute to do another round so here I am lying on the doctors table. Sure it's a horrible first two weeks but I know it will get better. I believe am 101 has at least helped me habituate I don't worry or care about my tinnitus all that much anymore and I suggest you all try to do the same because otherwise the road to recovery will be hard. Stop trying to look for it stop trying to measure the loudness because all you are doing is stopping your brain from changing your reaction to the noise. I know it's hard to do but ever since I changed my mind set stopped feeling sorry for my self and had some relief from the drug things have been much better. I know I will never be cured but I believe every day will be a better day I will not be posting again on this site all the best to all of you
Today it is so ringing that i feel like being paralyzed.
Anybody has/had the same experience ?
Anybody has/had the same experience ?
Ian Mac
Member
- Jun 1, 2016
- 321
- Tinnitus Since
- 2011
- Cause of Tinnitus
- Vestibular Nueritis, loud music (dubstep)
Yes most days, if I don't wear my hearing aid masker I hear bird noises in my right ear (and ringing in both ears).
Ty for your feedback Ian.
We are mid of August Auris should published the first results from this trial no ?
We are mid of August Auris should published the first results from this trial no ?
I wouldn't hold my breath.
Shady would be the optimal word to describe my experience with this whole process.
Ian Mac
Member
- Jun 1, 2016
- 321
- Tinnitus Since
- 2011
- Cause of Tinnitus
- Vestibular Nueritis, loud music (dubstep)
I'm sorry @Elgringo32. It's not fun to accept that our ears are doing weird things, even for a tinnitus sufferer it is weird. Especially when it's not our fault.
Sleep is very important. Without the hearing aid I can't sleep to many super fast fluctuations in pitch. Good luck.
Sleep is very important. Without the hearing aid I can't sleep to many super fast fluctuations in pitch. Good luck.
It's weird. Although AM101 hasn't given me the improvement I had hoped for (only minimal improvement), everything I have experienced through the process has been completely professional.
Pharmaceutical companies going through drug trials are some of the most volatile stocks out there. If you look at the top ten movers on on any given day (both positive and negative), you will most likely see a pharmaceutical company there.
http://ir.aurismedical.com/phoenix.zhtml?c=253572&p=irol-newsArticle&ID=2195679
Lets see what they are going to discuss on thursday.
Lets see what they are going to discuss on thursday.
Hi all.
I had my last checkup on Monday.
So in conclusion I have no improvement at all and have slightly worsening of sensitivity to different noises which is an absolute pain.
I'm still hoping that something will come out that can at least reduce the severity and loudness of this noise.
Don't no what to think of AM -101 as in the UK the NHS are very slow at responding, it took nearly 3 months before I got to see my ENT doctor.
As we all no AM-101 APPEARS only to have worked on patients around the 3 months mark.
Good luck to you all.
Tinnitus is the work of the devil.
I had my last checkup on Monday.
So in conclusion I have no improvement at all and have slightly worsening of sensitivity to different noises which is an absolute pain.
I'm still hoping that something will come out that can at least reduce the severity and loudness of this noise.
Don't no what to think of AM -101 as in the UK the NHS are very slow at responding, it took nearly 3 months before I got to see my ENT doctor.
As we all no AM-101 APPEARS only to have worked on patients around the 3 months mark.
Good luck to you all.
Tinnitus is the work of the devil.
I'm finished AMPACT , the running of trial program very profssional and sympathetic. Fingers x'd I see some benefit in the next months. I haven't seen any lasting benefit from the 1st round but maybe I had the placebo.
ATM don't know what to make of any of it, I cant easily reconcile the optimism from Auris releases vs pessimism from many on these forums, but Ive tried to give myself a chance as all who did this trial have done, so no-body here should regret doing the trial, Auris have spent $m's in a genuine effort to find a treatment and they should be respected for that.
In the worst this trial will I think stimiulate various other research efforts for tinnitus so hopefully something will come out in not too many years.
ATM don't know what to make of any of it, I cant easily reconcile the optimism from Auris releases vs pessimism from many on these forums, but Ive tried to give myself a chance as all who did this trial have done, so no-body here should regret doing the trial, Auris have spent $m's in a genuine effort to find a treatment and they should be respected for that.
In the worst this trial will I think stimiulate various other research efforts for tinnitus so hopefully something will come out in not too many years.
- Jan 27, 2016
- 229
- Tinnitus Since
- 01/2016
- Cause of Tinnitus
- Noise induced
Hey guys today I had my final appointment of the open label round and I decided against doing a 3rd round, so this will be my last update for the study. Everything checked out good, the doctors and research assistants were great as usual, and I am glad to have participated in this trial. They thanked me, and I thanked them even if the results did not end up as good as we all had hoped.
Trial(Completed):
AM-101 initial trial
Base T the day/week before AM-101 trial injections:
Left ear: 3/10
Right ear: 1/10
1 week update
2 weeks update
1 month update
2 months update
Results from AM-101 initial trial: I noticed a significant improvement immediately beginning with week 1. By the end of week 4 after injections I was having regular days or half-days of silence, as many as 4 that week, and lower T overall. After that they became more rare over the past 2 months, with 1-2 days of silence a week leading up to the following trial but my T held at lower levels on average.
Trial(Completed):
AMPACT/Open Label Round 1
1 week update
2 weeks update
1 month update
unplanned update 1
unplanned update 2
3 months update - Final update.
Date of initial T Onset:
1/21/2016
Cause: Noise induced. Ear buds. Prolonged session of producing music in FL studio.
Base T the day/week before AMPACT injections:
Left ear: 0-3
Right ear: 0-1
Tinnitus description before injections:
After the initial AM-101 trial, I ended up with fleeting T ranging below my baseline, and random days of silence. I noticed the best frequency of silent days was towards the end of the first month. By month 3, before this round of injections, they settled at around 1-2 days of silence a week.
Date of injections:
5/27/2016-5/29/2016, 4 months since onset
Have you felt any change/improvement/worsening since the injections?
Yes. Yes. No.
This round was definitely a different pattern than the previous, and by that I mean, it seems as if there was no pattern at all. Initially it began with no noticeable change during the first week of injections, and throughout the first month. The only thing I had in common with the first round was that week 4 was the best week after injections, with multiple days of silence, and barely noticeable T. Whereas in the first round I had a setback week 5, this time around the good days continued. It actually continued for the entire 2nd month. I had countless days of silence and T was not a part of my life for almost the entire. So things seemed really promising. Then....similarly to the first round, I had a setback. Except this time much more significant. My third month began with a string of 2 weeks of non-stop T, fluctuating anywhere from 1-3. I had maybe 2 days of silence the entire month. Whereas after the first round of injections, I had settled with 1-2 days of silence a week by my third round. It was definitely a more noticeable setback also because of the prolonged time period that I went without really noticing T, almost an entire month.
That setback was enough to make me change my mind about participating in another round, because I just can't see a reasonable pattern of improvement. It's far too random to attribute to the injections, even compared to the first round where the improvement there was immediate after the injections and continued to improve over the next week, all the way through the first month.
This time around, at best, even if we are to attribute my month 2 improvement to AM-101, the pattern seemed to show a delayed, temporary, reduction and improvement followed by a very long setback that is still continuing. And that isn't enough for me to continue with it. In the end, these days, sleep has a much more significant effect on my T, as has always seem to have been the case, than anything else. Whether it's loud and I sleep and I wake up with it lower, or whether I have silence and I sleep and it comes back I have the most solid correlations between T and sleep.
Current T severity and average T severity over the past week:
Current: 1/10. Stayed a pretty loud 2 and actually had one of my louder days today where it raised up to a 3 while doing my audio test in the audiologist booth. Ironically, when I was doing the test in the trial on previous visits, I seemed to have always had no T or nearly no T. Good thing there was no loudness matching today, or my results would have probably been counterproductive for AM-101 compared to my previous loudness matching tests.
Average over the past week: 2/10
Have you experienced any lasting (side) effects from the procedure?
No. I had my final follow up, everything was normal. My hearing seems to be the same as in the beginning of the study.
Will you participate in the next round?
No, for reasons explained above.
Trial(Completed):
AM-101 initial trial
Base T the day/week before AM-101 trial injections:
Left ear: 3/10
Right ear: 1/10
1 week update
2 weeks update
1 month update
2 months update
Results from AM-101 initial trial: I noticed a significant improvement immediately beginning with week 1. By the end of week 4 after injections I was having regular days or half-days of silence, as many as 4 that week, and lower T overall. After that they became more rare over the past 2 months, with 1-2 days of silence a week leading up to the following trial but my T held at lower levels on average.
Trial(Completed):
AMPACT/Open Label Round 1
1 week update
2 weeks update
1 month update
unplanned update 1
unplanned update 2
3 months update - Final update.
Date of initial T Onset:
1/21/2016
Cause: Noise induced. Ear buds. Prolonged session of producing music in FL studio.
Base T the day/week before AMPACT injections:
Left ear: 0-3
Right ear: 0-1
Tinnitus description before injections:
After the initial AM-101 trial, I ended up with fleeting T ranging below my baseline, and random days of silence. I noticed the best frequency of silent days was towards the end of the first month. By month 3, before this round of injections, they settled at around 1-2 days of silence a week.
Date of injections:
5/27/2016-5/29/2016, 4 months since onset
Have you felt any change/improvement/worsening since the injections?
Yes. Yes. No.
This round was definitely a different pattern than the previous, and by that I mean, it seems as if there was no pattern at all. Initially it began with no noticeable change during the first week of injections, and throughout the first month. The only thing I had in common with the first round was that week 4 was the best week after injections, with multiple days of silence, and barely noticeable T. Whereas in the first round I had a setback week 5, this time around the good days continued. It actually continued for the entire 2nd month. I had countless days of silence and T was not a part of my life for almost the entire. So things seemed really promising. Then....similarly to the first round, I had a setback. Except this time much more significant. My third month began with a string of 2 weeks of non-stop T, fluctuating anywhere from 1-3. I had maybe 2 days of silence the entire month. Whereas after the first round of injections, I had settled with 1-2 days of silence a week by my third round. It was definitely a more noticeable setback also because of the prolonged time period that I went without really noticing T, almost an entire month.
That setback was enough to make me change my mind about participating in another round, because I just can't see a reasonable pattern of improvement. It's far too random to attribute to the injections, even compared to the first round where the improvement there was immediate after the injections and continued to improve over the next week, all the way through the first month.
This time around, at best, even if we are to attribute my month 2 improvement to AM-101, the pattern seemed to show a delayed, temporary, reduction and improvement followed by a very long setback that is still continuing. And that isn't enough for me to continue with it. In the end, these days, sleep has a much more significant effect on my T, as has always seem to have been the case, than anything else. Whether it's loud and I sleep and I wake up with it lower, or whether I have silence and I sleep and it comes back I have the most solid correlations between T and sleep.
Current T severity and average T severity over the past week:
Current: 1/10. Stayed a pretty loud 2 and actually had one of my louder days today where it raised up to a 3 while doing my audio test in the audiologist booth. Ironically, when I was doing the test in the trial on previous visits, I seemed to have always had no T or nearly no T. Good thing there was no loudness matching today, or my results would have probably been counterproductive for AM-101 compared to my previous loudness matching tests.
Average over the past week: 2/10
Have you experienced any lasting (side) effects from the procedure?
No. I had my final follow up, everything was normal. My hearing seems to be the same as in the beginning of the study.
Will you participate in the next round?
No, for reasons explained above.
http://ir.aurismedical.com/phoenix.zhtml?c=253572&p=irol-newsArticle&ID=2196144
It FAILED on all efficacy endpoints, I am really not surprised !
And for safety:
The trial's primary safety endpoint, incidence of clinically meaningful hearing deterioration, was low with no statistically significant difference from the placebo group, supporting the safety profile of KeyzilenTM.
It FAILED on all efficacy endpoints, I am really not surprised !
And for safety:
The trial's primary safety endpoint, incidence of clinically meaningful hearing deterioration, was low with no statistically significant difference from the placebo group, supporting the safety profile of KeyzilenTM.
Obviously I wish I had known this last week, then I wouldnt be sitting here with roaring tinnitus 3x as loud as last week and nearly deaf with it. Hoping just the post injection spike and will pass, but I am feeling desolate today.
When they speak about safety why do they not speak about T/H worsened ?
A sever T/H is much more shit than loosing few hearing DB.
I hope that we will get the detailed results soon.
A sever T/H is much more shit than loosing few hearing DB.
I hope that we will get the detailed results soon.
You can download the presentation slides from "supporting materials" link on this page http://ir.aurismedical.com/phoenix.zhtml?c=253572&p=irol-EventDetails&EventId=5235839
More detailed results expected later this year - perhaps in combination with TACTT3.
More detailed results expected later this year - perhaps in combination with TACTT3.
What are the feeling of other participants here ?
We had much more to lose by having participated to this trial...this is my feeling.
We had much more to lose by having participated to this trial...this is my feeling.
How did they get good results in Phase 2 and now in phase 3 it is I think worse than doing nothing after onset .
What a really scam.
What a really scam.
The results for TACCT2 trial published today are disappointing. I managed to get into the trial just before it closed and went though two rounds. My experience was similar to what many have already posted. The first few weeks after the injections my tinnitus worsened and then returned to baseline, where it is still today. I do not regret going through the trial. If anything, it has helped me to habituate. I do hope Auris Medical and other companies will continue in the search for an effective tinnitus treatment.
Those posting that this is a scam, you're wrong. If it was a scam they would have charged you for being in the trial, it was the opposite. They also would have published false results in their favor when in fact they have not. Don't give this company a bad name. They are one of the only companies out there trying to find a solution for tinnitus.
To Auris Medical: thank you for your investment in this trial. Please continue the search for an effective tinnitus treatment. Failure is an inevitable part of success.
"I have not failed. I've just found 10,000 ways that won't work." Thomas A. Edison
Those posting that this is a scam, you're wrong. If it was a scam they would have charged you for being in the trial, it was the opposite. They also would have published false results in their favor when in fact they have not. Don't give this company a bad name. They are one of the only companies out there trying to find a solution for tinnitus.
To Auris Medical: thank you for your investment in this trial. Please continue the search for an effective tinnitus treatment. Failure is an inevitable part of success.
"I have not failed. I've just found 10,000 ways that won't work." Thomas A. Edison
I'm very disappointed to hear the results. I feel like I had a lot of time and energy invested in this trial forgoing other treatments in the acute phase to participate in it; though, I don't regret going through it. I really hoped it would succeed despite only seeing a minimal change in my tinnitus. Although, it seems like some members here hoped Auris would fail.
AM101 didn't seem to do anything for my baseline tinnitus, but it did seem to get rid of the occasional fleeting tinnitus I would get, but because of the way the questions were structured that doesn't come up.
The trial coordinator, the doctors, and the hospital where I did my injections were all great.
What's going to happen with the participants that are still in AMPACT in North America?
The followup trial has not yet concluded.
AM101 didn't seem to do anything for my baseline tinnitus, but it did seem to get rid of the occasional fleeting tinnitus I would get, but because of the way the questions were structured that doesn't come up.
The trial coordinator, the doctors, and the hospital where I did my injections were all great.
What's going to happen with the participants that are still in AMPACT in North America?
The followup trial has not yet concluded.
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