AM-101 Clinical Trial — Participants Updates and Discussion

[AlexSongitus]

my doctor told me I have a very good chance that I this noise forever rid .. he says it is a very good drug .. I'm in ulm / germany in dr . Mühlmeier .

Well from my experience and many others on here, it doesn't appear to be a miracle cure, but it can lead to improvements in some people, ranging from little to significant. Others noticed no change. The best you can do is give it a shot like the rest of it, keep your expectations low, and hope for the best. There really isn't anything else better at the moment that is backed by clinical research to try. Wish you the best.

 

[Michi1986]

that's true. but I think postive . I think you have to 4 months , a chance to spontaneous cure . I hope so. This noise makes mch done. But days of 30 said the doctor does this drug exactly as it should , he said, and I s still residual noise would I still can make the second passage . every day changes the pitch .. yesterday and today 1/10 8/10 ... I will continue to report

 

[AlexSongitus]

that's true. but I think postive . I think you have to 4 months , a chance to spontaneous cure . I hope so. This noise makes mch done. But days of 30 said the doctor does this drug exactly as it should , he said, and I s still residual noise would I still can make the second passage . every day changes the pitch .. yesterday and today 1/10 8/10 ... I will continue to report

Sure, you always have a chance for it to go away, even without taking anything. And the good thing is AM-101 won't lower that chance, but help it. The docs I spoke to at the trial believe fluctuations to be a good sign, in that it can be affected by medication. They seem to believe if it fluctuates, it's more likely to respond to treatment than if it's constant, the same all the time. Nothing wrong with being positive about it!

 

[Alue]

Sure, you always have a chance for it to go away, even without taking anything. And the good thing is AM-101 won't lower that chance, but help it. The docs I spoke to at the trial believe fluctuations to be a good sign, in that it can be affected by medication. They seem to believe if it fluctuates, it's more likely to respond to treatment than if it's constant, the same all the time. Nothing wrong with being positive about it!

I agree, wish mine would fluctuate more.
You have to ask, are the fluctuations due to the drug, or are they due to diet, sleep, and stress levels?

To be honest I don't understand the long post injection spike most people report. It doesn't seem to show up in the literature for the phase II trails, and from what I understand about the mechanism of action I thought it would be fairly quick if it does work. I'm sure the procedure itself causes a spike for many.
Then again some people have reported long spikes then marked improvement.

 

[Marlino]

Hi together,

I've got the offer to participate in AM-101 trial here in Ulm, Germany.

Since I'm doing better already I'm not so desperate anymore but more sceptical. I would love to get rid of it though.

Can somebody who is really in this tell me about side effects and about benefits risks ratio? Would you do it again?

 

[Hopeful1]

My side effects:
Temporary spike
Pulsate tinnitus for few days
Presure issues with ear

Bene.
May lower T for some days of week...cant tell for sure.

Ratio:
I think its 30% chance of a some reduction from my analysis.

 

[Michi1986]

I think you very good opportunities rid his tinnitus with this drug . as a tinnitus in the brain is produced should be associated brain additionally train told me my doc . I think many test this drug and have tinnitus thereby lost her , otherwise you would not continue to test it . Auris medical apparently wants 2017 to the market .

 

[Hopeful1]

My T quiet low today...but it changes each day.....is this because of AM 101.....I am not sure....i had only 2 low days ( though not this low) before injections....now i have many low T days.

 

[Michi1986]

I find it very unfortunate that you can read anywhere on the internet that this has medical someone healed . Ode has read postives anyone of you ? that makes me tame . Every day changes my tinnitus . Today he is loud again , and about 30 days after the last injection . is with you so ? beautiful Sunday to all

 

[TC426]

Hi together,
Since I'm doing better already I'm not so desperate anymore but more sceptical. I would love to get rid of it though.
Can somebody who is really in this tell me about side effects and about benefits risks ratio? Would you do it again?

Well, obviously the range of feedbacks here in the forum is quite broad.

@PandorasHope has invested a lot of time and summarized people's experience in late 2015. He published a file with all his findings here here (Find the complete post on page 34, here)

Summarized on what I read and based on my own experience, I would say that the effect of the treatment typically is either a change of Tinnitus from significantly better to moderately worse OR, in many cases, no change at all. Whether a change is for the better or for the worse is subjective in nature, thus hard to predict.

Personally, the risks I see associated with the procedure (aside from temporarily muffled hearing and ear pain):
- Subsequent ear infection (which may or may not affect T temporarily or permanently)
- Change in sound perception (mostly temporary)
- Risk of temporary or permanent damage of ear drum including auditory ossicle (caused by the injections)
- Risk of additional noise damage due to procedure
- General complications during the physical procedure

Also, from the medicinical aspect, don't forget that after all, this is a medicinical trial. Long term effects (even if unlikely) are not yet completely known. Also, in phase III the chance of being in the placebo group is 40%.

What personally convinced me to participate was that I wanted to be sure to have done everything I could to find my way back to silence. Personally, I estimate a 30-50% chance that AM-101 will actually be released to the market. In other words, there is no guarantee that the treatment will be available beyond the phase III stage. Thus it came down to a "now or (maybe) never" decision. However, I am not sure if I would do it again. At this stage, I think it's fair to say that AM-101 is not the general miraculous T cure everyone is yearning for. Some people have reported a relief, but to my knowledge, noone has gotten completely rid of his T so far (correct me if I am wrong) and many people reported no change at all, even after the open-label round.

It is important to point out that I do not want to encourage or discourage anyone to participate in the trial. However, I strongly advise you to carefully think about it in depth before deciding for or against it. Most people who suffer from tinnitus will be affected on the long term (until a cure is found). Logically, any change (for the good or for the bad) will have the same lasting effect. If you feel that you are handling your T well, you have to make up your mind whether you are able to cope with it in the future and avoid the risks of the trial, or take a chance/risk to change your situation - making your T better or worse.

This is my personal opinion. Other people may see it differently.
I will publish a final summary by the end of July. May include some lines from this post.

 

[Marlino]

What personally convinced me to participate was that I wanted to be sure to have done everything I could to find my way back to silence.

I think this is psychologically an important point to make peace with T in the long term. I still have to talk to the Doc about it but I'm now in favor of doing it.

 

[Michi1986]

why not to make it to the market ? I wll now nothing stupid to say but I think many people where that has chipped or medical help not write in this forum . I notice after 30 days a slight improvement so far. how long they had ti where they have started to injections ?

 

[TC426]

I think this is psychologically an important point to make peace with T in the long term. I still have to talk to the Doc about it but I'm now in favor of doing it.

Completely agree. It's the choice between taking a opportunity that includes risks, and doing nothing but knowing that there could have been a chance. However, I think it is important not to become too philosophic about it. It should remain a rational decision after all.

why not to make it to the market ? I wll now nothing stupid to say but I think many people where that has chipped or medical help not write in this forum.

There are so many restrictions for legalization of a drug. Only a minority of drugs ever makes it to the markets. For tinnitus, no drug has ever been approved. Let's hope for the best, but my gut feeling is that this will be a "nailbiter", with uncertain outcome

 

[AlexSongitus]

I agree, wish mine would fluctuate more.
You have to ask, are the fluctuations due to the drug, or are they due to diet, sleep, and stress levels?

To be honest I don't understand the long post injection spike most people report. It doesn't seem to show up in the literature for the phase II trails, and from what I understand about the mechanism of action I thought it would be fairly quick if it does work. I'm sure the procedure itself causes a spike for many.
Then again some people have reported long spikes then marked improvement.

I didn't experience those spikes, but fluctuations I did. The first time around I got silence immediately beginning with the procedure, then after, one day of silence and one day of loud T above my base, which repeated at least once and then silence and low T from that point on.

This time around I'm not even getting that. I'm on day 2 right now. I had silence yesterday all day, and woke up with low T which dropped off to silence again today. My first time around, today would have been the day where I had a big spike. So far it's looking good though I did get muffled ears after my third injection, and my right ear is still pretty muffled.

Are you seeing any improvement Alue? Have your ears cleared up completely yet?

 

[Alue]

I didn't experience those spikes, but fluctuations I did. The first time around I got silence immediately beginning with the procedure, then after, one day of silence and one day of loud T above my base, which repeated at least once and then silence and low T from that point on.

This time around I'm not even getting that. I'm on day 2 right now. I had silence yesterday all day, and woke up with low T which dropped off to silence again today. My first time around, today would have been the day where I had a big spike. So far it's looking good though I did get muffled ears after my third injection, and my right ear is still pretty muffled.

Are you seeing any improvement Alue? Have your ears cleared up completely yet?

My ears cleared up within a day or two following the third injection, they were extremely clogged then quickly unclogged when my sinuses cleared up, I had pulsate tinnitus at night for about a week. Tinnitus seemed a bit lower on injection days 2 and 3. It has been a bit more intrusive for the past few days, I have also been under stress and not sleeping as well so that could contribute. I'm still waiting to make a determination.

I don't know what to think, but I'm trying not to over-analyze it this time. My T is still very bothersome, and it's hard coming to grips with this being permanent at this level.

 

[Bobby B]

To be fair It seems that a lot of people here didn't get the real drug until several months post trauma maybe that's one factor
@TC426 you were at months 6 when you got the first shot ?

Perhaps this needs needs to be done a few days after Trauma to get a chance to even work

 

[TC426]

@TC426 you were at months 6 when you got the first shot ?

Yes, 6 months for the first shots (double-blind), 9 months for the second round (open-label).

 

[Alue]

To be fair It seems that a lot of people here didn't get the real drug until several months post trauma maybe that's one factor
@TC426 you were at months 6 when you got the first shot ?

Perhaps this needs needs to be done a few days after Trauma to get a chance to even work

I have wondered if the window of opportunity is much less than we had thought for some time now. I try to quell that fear in hopes that it helps.

In the early studies, AM-101 completely blocked tinnitus from forming in rats up to 4 days after acoustic trauma with a gradual decline of effectiveness after that. Somehow this is translated into a longer time frame for humans because of differences in physiology. I guess that's one thing they are trying to figure out with TACTT2 and AMPACT. I guess we won't know until the study results are released.
There was a statistical difference in improvement for the up to 3 month category in TACTT1.

 

[Hopeful1]

I too believe is should given within a week...but unfortunately the quickest anyone can get it is around 5 weeks..i got it around 1.5 months after exposure....and doctor said i got it earlier than anyone in that centre.

 

[Alue]

I too believe is should given within a week...but unfortunately the quickest anyone can get it is around 5 weeks..i got it around 1.5 months after exposure....and doctor said i got it earlier than anyone in that centre.

Yes, you are lucky to get it that early. I applied within a week after my acoustic trauma and wasn't able to get it till 2.5 months. I still feel lucky to be given the chance to participate, they have been good to to me, but wish I could have gotten it ASAP too.

 

[Hopeful1]

I too contacted within a week but had to wait 2 weeks for screening appointment and 2 more weeks of filling the diary....and the doctor and nurse treated me very well...i think its imposs8ble to get it within a month.

Doctor says they dont want to give it to someone within a week as it might resolve by it self.

 

[TorDog]

Well Tomorrow I go in for my first round of open label shots. Do to issues at the facility I have been going to they had to delay this round of shots for me. I'm at the 7 month point now. I saw no improvement with the first round so I'm hoping it was the placebo at this point. Even if it was, based on comments I have seen, I'm wondering if I will see any improvement this late. Still I have to give it a try. I've had a few bad days in the last few weeks to the point where I am getting headaches.

Still, I am dealing with this better every day and, as I become acclimated, I am able to ignore it for longer stretches. I mention this only because it helped me in the early days to read posts from folks that have had it a long time that mentioned this would happen. Slowly I am getting my life back even though the Tinnitus has not improved or gone away.

Attitude has been everything. The day I decided to quit wallowing in it and just acknowledge that it was there and that it pissed me off and then just go about focusing on something else was the day that I started to turn the corner with this.

Of course this assumes that it does not get worse from here.

I wish everyone here the best of luck. I'll keep this forum posted with the results of this round, I wont go in to the experience again unless there are significant differences from my first round which I posted here

https://www.tinnitustalk.com/thread...ticipants-updates-and-discussion.6558/page-47

 

[TC426]

I have wondered if the window of opportunity is much less than we had thought for some time now. I try to quell that fear in hopes that it helps.

In the early studies, AM-101 completely blocked tinnitus from forming in rats up to 4 days after acoustic trauma with a gradual decline of effectiveness after that.

May be a relevant factor or not. As long as experts cannot even agree on whether a tinnitus becomes chronic after few weeks or several years, I guess try and error is the only way to find out.


On a different note, I have to say that I am getting increasingly worried about the development in my case. The second week after the open label injections I had signifcant improvements, as reported. In week 3, it gradually got worse again, slightly worse than the baseline. That continued this week and for the past 5 days, it has remained on the same, intense level - no changes anymore.

Prior to the second set of injections, I (usually) got relief when I was outdoors, could not hear it in public transport or cars. Only when I plugged my ears, I could clearly sense it. Also, it used to be much better when I was at home and faded away during sleep, so that it was quite calm during the night and did not bother me too much. The first hour after getting up was quite peaceful as well. Thus I used my weekends and evenings at home to recover from the intense, long days at the office, where it usually peaked.

Now, it is partially inverted. For the past 5 days, it was present in my sleep, which kept me from sleeping. I get up, it's there instantly. When I leave the house, it gets worse immediately. I can hear it in the train and when I am walking in the streets. At the moment, it's everywhere, and it's very prevalent in most situations. When I plug my ears, it does not increase, it remains the same (!). Unchanged are the rough times at the office. I am feeling exhausted...trying to remain positive, but it's hard.

So far, I kept it together with the outlook that this is a normal part of the healing procedure and will pass. But now it has been 4 weeks and I think that both the healing process and the effectiveness of the Esketamine will come to terms. The current situation is significantly worse than prior to the injections and this must not be the final outcome

Is there anyone who participated in the open label round and can report any changes past the 4-week mark? Would appreciate if any who can relate to the situation replied.

 

[AlexSongitus]

I have wondered if the window of opportunity is much less than we had thought for some time now. I try to quell that fear in hopes that it helps.

In the early studies, AM-101 completely blocked tinnitus from forming in rats up to 4 days after acoustic trauma with a gradual decline of effectiveness after that. Somehow this is translated into a longer time frame for humans because of differences in physiology. I guess that's one thing they are trying to figure out with TACTT2 and AMPACT. I guess we won't know until the study results are released.
There was a statistical difference in improvement for the up to 3 month category in TACTT1.

Yeah time could be a bigger factor. I mean I did experience silence immediately during all 3 injections from what I assumed to be Lidocaine and then silence the next day during the trial round at 1.5 months since onset. This time I did not get silence, so at the very least, if it was from Lidocaine, it doesn't seem to have any effect at the 4 months mark. I did get silence my first 2 days post injection this time, whereas before I was really only getting it 1-2 days a week but now on Monday it started at a 1 and ended up at about a 2. Too early to say, but I fear time may play a much bigger role than initially thought and that might be why I experienced such positive results, because mine was relatively fast compared to most members here. The other thing is that without a doubt my T was better within the first month after the injections, than the past 2 months, so it also brings into question if the benefit is temporary or not. Still a bit too early to say, but we will see.

 

[Michi1986]

I've since 2 weeks everyday fluctuations . I also do not know what 's going on .. this is norma ? I inject the last days before getting 33 ...

 

[Charlie396]

I think I'm pretty close to being done guys.

Exactly one month ago I had the open label round injections. For 1 week the T was a little louder due to my right ear feeling clogged. Only lasted about a week though. Aside from that, absolutely zero improvement or changes. No spikes, no tonal changes. Nothing. I very much have a 'oh well at least I tried' attitude. Seeing as how the numbing agent apparently didn't work on me and those injections were literally one of the most painful things I've ever felt I don't feel much desire to continue with another round. My next hearing test is this Monday and I'm really leaning towards just calling it quits.

By the way, anyone know when we're supposed to get our check for the injections? First injections were in February and still nothing. I'd at least like to get something out of this bust.

 

[Bobby B]

Auris will present some ir info to investors at a conference next week in NY on June 9 perhaps an update on the tests

The site will have the session recorded

 

[AlexSongitus]

Trial:
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.



1 week update

Trial:
AMPACT/Open Label Round 1

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. Not sure. No.

During the initial trial I got silence immediately during each procedure, right after the numbing gel, which I and many assumed was from the Lidocaine numbing gel. That did not happen this time around. The first day of my injections I actually had a silence day before we even started, so it coincided with one of my regular silent days. I experienced 2 days of silence on 2 consecutive days after my third injections and since then I have had fluctuating T, constant at all times, never above my baseline.

It was pretty easy to see a big difference the first time around. Aside from the two back to back days of silence right after the injections during this past week I could not tell any difference from before this round's injections. My T has been below baseline and fluctuating. The only other noticeable difference between the rounds, during my first round I did also experience 2 days where my T spiked above my baseline. This time, it did not, but I am also not noticing the same improvement.

Current T severity and average T severity over the past week:

Current: 1.5/10. After 2 days of silence following the my last injection, it has fluctuated between a 1-3.


Average over the past week: 1.5


Have you experienced any lasting (side) effects from the procedure?
Nothing major, but my right ear is still a bit muffled a week later. Hope it clears up completely soon. I did experience some pain this time overnight while doing the injections, that included some tooth pain and noticed more leaking immediately after the injections compared to the first round.

Will you participate in the next round?
Unlikely. So far I am not seeing the same benefit as I got from the initial round. I do believe I got the real drug the first time around, and it appears time may play a bigger role than initially thought. I am at a bit over 4 months now, while the first set of injections happened at 1.5 months. However, it's still week 1. After the first set of injections, I remember my best week being week 4, after which, it gradually settled a bit worse. So I will wait and see how it's going to be a month from now. I think the only way I end up doing another round, is if I notice an improvement, meaning 3-4 days a week of silence regularly. Then I might decide, why the heck not, let's see if I can completely get rid of it. Not holding my breath for that.

 

[The Red Viper]

@AlexSongitus, your documentation thus far has been very critical. While I can't tell you what to do, it would be cool to continue on "in the name of science."

 

[AlexSongitus]

@AlexSongitus, your documentation thus far has been very critical. While I can't tell you what to do, it would be cool to continue on "in the name of science."

I'm glad it's been of use. We'll see how it goes. Even though there are no reported serious side effects, I do have in the back of my mind that overall I have now had someone stick a needle in my ear drum 12 times all together, and knock on wood, everything seems fine. But we're still talking about getting a needle stuck in your ear drum so there is always a risk and you have to weigh the expected benefit with that risk. At what point do the percentages of even something as stupid as say....the doc slips while he's pushing the needle...begin to catch up?