AM-101 Clinical Trial — Participants Updates and Discussion

[Elgringo32]

I remember that the suction device used to remove the anesthetic was a real nightmare for me, especially on my right ear. The sound was like a rocket. And when you have hyperacusis like me it is a really bad.

 

[Ian Mac]

It seems that the business of restoring hearing could cause a restoration in Hearing at the expense of an increase in hyperacusis and T. Particularly in clinical trials.

 

[Elgringo32]

@Ian Mac AM 101 is for tinnitus not for restoration of hearing.

 

[Ian Mac]

@Ian Mac AM 101 is for tinnitus not for restoration of hearing.

Well that's a great thought thinking you can stop T without addressing the problem. Which is physical damage. You can't bypass the damage by tinkering with brain connections no matter what the hardware is not sending the right signals no matter what you do you need to repair the hardware. I don't believe in brain ringing that simply arises without physical cause.

 

[GregCA]

Well that's a great thought thinking you can stop T without addressing the problem. Which is physical damage. You can't bypass the damage by tinkering with brain connections no matter what the hardware is not sending the right signals no matter what you do you need to repair the hardware. I don't believe in brain ringing that simply arises without physical cause.

Not all solutions involve getting rid of the root cause. The best ones do of course, but at the moment I'm pretty sure many would settle for a solution that just addresses the symptoms. Sadly, we have neither.

I'd definitely jump on any solution that addresses my T, even if it doesn't fix my hearing.

 

[TorDog]

Well, I go in Tuesday for my one month follow-up after my second round of shots. Sadly, I have noticed no improvement. I have only had one side affect that lasted beyond the 1 week mark. My right ear will sometimes hurt when my head is slightly stuffy or if I accidentally seal my ear while cleaning it. The pain is not very bad. More annoying than anything. It does not last more than a few minutes. Its the worst when I first wake up. I'm assuming this is because I am a bit stuffy when I wake up in the morning. It is not a daily occurrence. On a scale of 1 to 10 its a 1.

I have a 3rd round of shots scheduled. Since I can quit the study at any time, I will leave them scheduled for now. However, if I see no improvement before I am scheduled to receive the next round, I can't see me going through another round.

 

[Iwan K]

Guys, based on the reviews I read, it seems that nearly everybody had his / her symtpopms worsened after participating in the trial. What is the purpose of that med being marketed at all ?

 

[Elgringo32]

Yes I do not understand why did they decide to launch phase 3. The purpose seems to get the money back.

 

[AlexSongitus]

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(Active):
AMPACT/Open Label Round 1

1 week update
2 weeks update
1 Month 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.

After not noticing any significant change my first 3 weeks after the open label round set of injections, once again, Week 4 seems to be a lucky week for me. I had my best week since the injections week 4, just like after the initial trial, with 4 days of silence and very low T in between. I barely noticed I had T. Even felt courageous enough to play my guitar for a bit. Then, once again, similarly to what happened after the initial set of injections, week 5 started off with 2 days of loud T, a 3/10, but now over the weekend I once again got a day of silence, including when I woke up this morning. After the initial trial week 5 for me started a week of relentless T that lasted for over a week every day. A bit too early to say, but week 5 seems to be an improvement so far when compared to week 5 after the initial trial. Last time around, week 5 is when the set back happened, and eventually over the next 2 months it settled around 1-2 days of silence a week. We shall see where I end up this time around.

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

Current: 0.5/10. Woke up in complete silence, took a nap, after my nap, it's barely noticeable.

Average over the past week: 1

Have you experienced any lasting (side) effects from the procedure?
No. I had my 1 month follow up last week, everything still checked out fine.

Will you participate in the next round?
My feeling on this remain the same. I talked to the docs about it and they feel the same as I do. Only if I notice another significant improvement like I did from the first round, and I am entering the period where I should be able to tell if this round did anything more or not, since the first 3 weeks did not show the same immediate improvement the first set of injections did. My last appointment is August 7, so I will have to decide about 2 weeks in advance if I will go for yet another around or not.

 

[Alue]

So, it's been a while since I actually updated on AM101. Since my last injection (the open label) I can't say my baseline ultra high pitched tinnitus has changed much. I'd say it's about the same, same with tinnitus annoyance/impact. I am still really struggling with my tinnitus which I can hear over everything and I would rate around a 7/10.

One thing I have noticed is that I no longer get any fleeting tinnitus in my right ear. Every once in a while I would get this 'beeeep' in my right ear (which is my better ear) that would last a few seconds. About a month after the injections I realized that once things calmed down I haven't had that any more at all.

So to sum it up I'm on the fence for no improvement or minor improvement.

I do think that most people that have worsening from the injections have it because of the procedure itself not the drug. Especially when suctioning is used.

 

[Elgringo32]

We need a survey to know if for people who have worsened Tinnitus since the injections they also had suctioning.
For me yes.

 

[Ian Mac]

So, it's been a while since I actually updated on AM101. Since my last injection (the open label) I can't say my baseline ultra high pitched tinnitus has changed much. I'd say it's about the same, same with tinnitus annoyance/impact. I am still really struggling with my tinnitus which I can hear over everything and I would rate around a 7/10.

One thing I have noticed is that I no longer get any fleeting tinnitus in my right ear. Every once in a while I would get this 'beeeep' in my right ear (which is my better ear) that would last a few seconds. About a month after the injections I realized that once things calmed down I haven't had that any more at all.

So to sum it up I'm on the fence for no improvement or minor improvement.

I do think that most people that have worsening from the injections have it because of the procedure itself not the drug. Especially when suctioning is used.

I would love for that whining beeeep in my right ear to go away, it's the only noise I can't mask with the hearing aid, good for you! Mine also fluctuates at about 2- 3 beeeeps every 10 seconds, did yours act like this also? Was it constantly coming and going without a break? Happy to hear you've improved slightly I don't know what I would give to silence just this one noise of the many noises. Of all my noises it's the 2nd most annoying, my damage is from labrythitis which is why my T is severe, how did you get yours? I also hear a bird in my right ear and what sound like tones, as if there is a quiet song playing in the background right ear.

 

[Alue]

I would love for that whining beeeep in my right ear to go away, it's the only noise I can't mask with the hearing aid, good for you! Mine also fluctuates at about 2- 3 beeeeps every 10 seconds, did yours act like this also? Was it constantly coming and going without a break? Happy to hear you've improved slightly I don't know what I would give to silence just this one noise of the many noises. Of all my noises it's the 2nd most annoying, my damage is from labrythitis which is why my T is severe, how did you get yours? I also hear a bird in my right ear and what sound like tones, as if there is a quiet song playing in the background right ear.

Well my most irritating tinnitus, the ultra high pitched head hissing hasn't changed. The fleeting tinnitus that was definitely in my ear would come on maybe a few times a week, that seemingly went away. The only time I got a really bad spike is when they suctioned, and they did not suction this time.

Still, tinnitus is extremely bothersome to me.

 

[Ian Mac]

Well my most irritating tinnitus, the ultra high pitched head hissing hasn't changed. The fleeting tinnitus that was definitely in my ear would come on maybe a few times a week, that seemingly went away. The only time I got a really bad spike is when they suctioned, and they did not suction this time.

Still, tinnitus is extremely bothersome to me.

I see, not the same.

 

[OddV]

I still have tinnitus... At onset, it was an 8/10

After injections, it was 2/10.

Almost 2 years later (since onset) it's a 2/10.

Ive habituated for the most part and can ignore it 90% of the time. I do find myself gritting my teeth occasionally and have to remind myself to relax my face.

 

[Hopeful1]

Good to hear that @OddV .... is you T constant or fluctuating....mine is fluctuating ......some days its low...other days is quiet high...

I had injections or placebo mid may, its not got any better since.....i have my open label on august first week(it will be 4 months since T onset).

Hopefully i can reduce my T as well. At my centre only one person had improvement immediately and surely after injections. Are you sure you T lowered by AM 101?

I ask this bcoz i have side effects after injection, my ears pull/pop when i yawn swallow or move my head back. I am not sure if another round of injections make my ear pressure problems worse. Do not want to risk when no one had any definitive benefit with AM 101.

 

[Elgringo32]

For me it is nearly 4 months since my T and hyperacusis onset. I had injections end of May. My hyperacusis has dropped a little and I have no more pain. However since the injections T is fluctuating (and reactive, it was not the case before) with days with high pitched and some others low. T is for me more intrusive since injections as I can hear it even if I do not think about it. Before I was able to discuss and to work without paying attention to it. Now it is no more the case.

 

[Ian Mac]

For me it is nearly 4 months since my T and hyperacusis onset. I had injections end of May. My hyperacusis has dropped a little and I have no more pain. However since the injections T is fluctuating (and reactive, it was not the case before) with days with high pitched and some others low. T is for me more intrusive since injections as I can hear it even if I do not think about it. Before I was able to discuss and to work without paying attention to it. Now it is no more the case.

Fluctuating is much more intrusive than constant high pitch ringing. I have mine from labrythitis, so I don't know what your hearing, but I was syicidal until I got a hearing aid with a masker (worm day and night) which, over months, has been tuned specifically to project avcombination of tones which mask the fluctuating "bird noise" and I hear constant ringing, I honestly still can believe it and check it all the time but when I wear the masker I don't hear fluctuations and I can think and SLEEP again! The hearing aid design is pretty awesome actually you don't feel s thing but you hear whatever you've programmed it to, there are also some fun settings once you get your tinnitus under control 1) you can listen to random algorithmic tones which play on top of whatever your doing, like a nice melody to your day. 2) there are multiple masking settings so you can try different noises to match your T, and also once you've got one setting perfectly masking the fluctuations, you can set the 2nd masker too have more low-end during bedtime. 3) you can turn off the hearing aid portion of you don't need it. Mine cost $2000 that's the bad part but I mean seriously what wouldn't you pay to mask the fluctuations and just have constant T again?

If I could go back to when I had Perfect NO Tinnitus I would STILL go buy one of these because of how fun they are, who doesn't like the sound of a fan at night? Who doesn't like a masker at night?

 

[Penate]

You lucky you can masked, but my is inposible to mask .

 

[Ian Mac]

So many type-O's above, I tried to edit it but my phone died now I can't edit, sorry everyone.

 

[Ian Mac]

You lucky you can masked, but my is inposible to mask .

Your lucky your T doesn't make you suicidal. If your T was truely suicidal a hearing aid WILL save your life. That's my experience.

Your right you can't mask classic high pitched Tinnitus from loud music, yes I have constant high pitched ringing which can't be masked pretty bad but I don't talk about it because it's nothing compared to the sound of three birds fighting over a morse code machine in my right ear from labrythitis, google it and hope you never experience this little known viral infection that last two months and destroys your life.
Those noises are so disabling that's why fluctuating T is a whole another level than classic constant centered "brain ringing". The masker is specifically to cover up the noise of fluctuating bird noises and shit. The constant T ringing is really not a big deal you habituate to it and go on with your life. I'm specifically addressing @Elgringo32 who has FLUCTUATING Tinnitus along with "normal" white noise classic constant central high pitch ringing tinnitus.

 

[Penate]

I have metalic jets engine in my ears,a power transformer very high pitched into my head and sssssssssss sounds in the back ground every thing together and 10/10..

 

[AlexSongitus]

Just wanted to give another unplanned update since my next one isn't due for a month. I mentioned before that after not noticing any difference after this round of injections during the first month, all of a sudden week 4 was my best week again just like during the first round of injections, but in addition, also that I was off to a good start week 5 as well.

I am happy to report it continued that positive trend. I haven't wrote the days down to be exact, but I have had at least 4-5 days of complete silence week 5, including yesterday and today back to back. So that is a pretty big difference when compared to the first round's week 5, where I had my big setback. So far week 5 has been as good as week 4, if not better. I think over the past 2 weeks I really only noticed it 2 or 3 days. Other than that I was either in complete silence or so low I was able to completely ignore it, not even think about it really.

No sure what to make of it, yet. There is still a chance it could regress over the next month like it did during the first round, but if this positive trend continues, it's going to be a very tough decision coming up in about 3 weeks whether I want to go ahead and try yet one more round. I said I wasn't going to do another if I didn't notice an additional improvement, but if I go from 1-2 days of silence a week, to 4-5 days of silence a week, that would qualify as a pretty significant improvement from round 2 as well.

 

[Elgringo32]

@Ian Mac thank you for your feedback. I think I will try hearing aids or other in the next few weeks before becoming suicidal (I am really not far away as every minutes of my new post injections life is a struggle).

 

[Hopeful1]

I had improvements for a couple of weeks after am 101 or placebo ......and did swimming for an hour and since then T went up in intensity(that is i hear in more areas of brain).....though i still have a few good days....T goes up for a couple of days when i excercise.

So....my dilemma is to excercise or not to?......i am thinking to just stop excercising after open label next month and see how AM 101 works on T..as i feel excercise has undone any improvement i had from AM 101

 

[Dutchy]

How long do they plan to go on with these trials?is there any information about the efficacy of AM101 that has been published?.

 

[Hopeful1]

You only get one trial(done) and open label which i will have in August.

is there any information about the efficacy of AM101 that has been published?.

http://www.ncbi.nlm.nih.gov/pubmed/24603353

 

[Elgringo32]

Before injections i was able to drink few glasses and to forget my tinnitus and now it is no more the case T is much more intrusive and keep me from being well in this "drunk" situation. Do you have the same feeling ?

 

[Ears Hurt]

Everyone was so hopeful of AM101, but it sounds like it made people worse.

 

[Hopeful1]

Everyone was so hopeful of AM101, but it sounds like it made people worse.

From hopeful to hopeless!