AM-101 Clinical Trial — Participants Updates and Discussion

[Mario martz]

Really amazing how we all respond so differently to the procedure. I actually liked the suctioning. It was like someone scratching an itch I had for a long time and by the time he finished suctioning it out, I had complete silence.

If they used Lidocaine, I really don't get why no one else is responding positively to Lidocaine. Lidocaine is known to quiet T or even silence it and had that effect within the 15-30 minutes on me. And it wasn't a fluke either, because it happened 3 days in a row before each injection

That's concerning about the blood. I had that the night after my 2nd injection in my left ear and they had to clean it out before my 3rd injection, but not during the procedure. Yours happened right after the injection?

How are you doing these days Alex!?

 

[AlexSongitus]

How are you doing these days Alex!?

I wrote my one month report on the previous page. Overall I'm still doing good, still fluctuating, but not quite as good as the 1st month and certainly not as good as week 4. I had a one week setback week 5 where it was back every day at or below baseline, but after that got better again and started getting silence and low T days again. I had probably the worst day yesterday after listening to some music, but before that I had 3 days of silence, and today its been a 1 all day so far in my left ear, silence in my right. So yeah, it's fluctuating between silence and a 3, depending on the day, but overall still a significant improvement from before the injections. Looking forward to round 2.

 

[Mario martz]

I wrote my one month report on the previous page. Overall I'm still doing good, still fluctuating, but not quite as good as the 1st month and certainly not as good as week 4. I had a one week setback week 5 where it was back every day at or below baseline, but after that got better again and started getting silence and low T days again. I had probably the worst day yesterday after listening to some music, but before that I had 3 days of silence, and today its been a 1 all day so far in my left ear, silence in my right. So yeah, it's fluctuating between silence and a 3, depending on the day, but overall still a significant improvement from before the injections. Looking forward to round 2.

thats great! days with silence sound awesome!

 

[liquefact]

Do you remember your tinnitus loudness matching level at the beginning and at the end? Was there any change in that?

What about your loudness / annoyance levels?

I never got these metrics from audiologist but i'm planning to in my next control visit. Even though it's completely subjective, my T is slightly weaker than before, however the annoyance is way down.

For the last two days, there's been an additional drop in the T loudness. Even though it was easily audible when i plugged my ears, I could not hear the T outside the home for like 8 hours. I had lowered my expectations after injections as i was completely fine with this level but this surprise drop is more than welcome.

 

[bellringer]

I don't think the treatment is effective. Both rounds I had about two months of quieter ringing following injections before coming back to full force after two months. I am approaching my one year anniversary and I am beginning to habituate better. Getting to sleep can be tough, but I am mentally better. I have improved a little in the last couple of months as my tone frequency range is no longer all over the place.

 

[TC426]

Here is my first update about the follow-up study.

Overview of past updates:
24 hours after last injections
1 week after last injections
1 month after last injections
2 months after last injections
3 months after last injections

This week, I had my second injections with the last treatment done yesterday.

Generally, the setup was different this time as I had all three injections within 36h (for the previous round, they were distributed over 7 days (Mon/Wed/Mon)), so it was considerably more intense.

Below my experience from this week:

Scale:

• 0 = very low/inexistent
• 5 = medium
• 10 = extremely high

-----------------------------------
Round #1

Before: Flooding the ear with some narcotic fluid, wait 10min, drain it. I convinced the doctor successfully to not use the suction device to clear out the rest of the liquid, as I considered it disturbingly loud and was scarred that it could do further damage my ears. The doctor agreed and dried the rest up with a tissue instead.
The injections went very well:

• Pain level: 0/10
• Discomfort level: 2/10

After: Full feeling (have only had that in phase III after the 3rd round), leakage from right ear almost instantly and also over night. Extreme headache which lasted until the morning after.

-----------------------------------
Round #2

Before: Again numbing the ears with soaked cotton placed on the ear drums. After 10min waiting, injections followed:

• Pain: 3/10
• Discomfort level: 5/10
  

During the injection in the right ear, the doctor slipped with the needle, hurting the ear channel which caused blood to flow out of the ear. This would not have been tragic, but in order to assess the injury, the doctor decided to use the suction device to get a clear view. Again, it was unbearably loud and caused an instant spike in my right ear, which has lasted since (from 3/10 to 7/10)

After: Again, total "fullness" on both ears and leakage. Sore feeling and significant increase of T in the right ear after suction. Slightly more disoriented than after the first ones. Again a headache which lasted until the morning after.

-----------------------------------
Round #3

Before:
Same as second injection:

• Pain: 1...5/10 (No pain in right ear, but quite painfull in the left one)
• Discomfort level: 8/10

After: Very full feeling, lots of popping and leaking even 24h after. Significant hearing loss due to filled ears.
-----------------------------------

Situation today:

Apart from the very numb feeling and the common hearing loss, the T has mostly shifted to my right ear, where it is stronger than ever. Frankly speaking, I am absolutely horrified by the current situation. While the left ear is feeling pretty happy and very similar as after the phase III injections, the T on the right ear has approx. trippled and significantly "gained power" for the first time since participating in the AM-101 trial. I can only hope that this is due to the general procedure as such and has nothing to do with the use of the suction device, but got to admit that I am close to panic because it is so intense (and I never panic). I am really scared that the T volume will not go back to baseline in my right ear and that the use of the suction device caused additional damage to my ear. If anyone has any advice to share about similar experience, I would highly appreciate it.

 

[Charlie396]

48 hours since the final open label injection. Hearing is really muffled. T is definitely louder. God I hope this goes away.


How's everyone else doing?

 

[TC426]

I am close to a complete breakdown by now. This has been very different from my phase III experience so far.

The T increase in my right ear is far beyond what I usually get when I block my ears i.e. use ear plugs for a long period of time. I would rate it at 8/10. I can hear it in the shower, the train, when driving my car, etc. It keeps me from sleeping and eating. Furthermore, it has developed some sort of reactive character, especially when I switch on the TV or try to listen to some music, it gets amplified.

So I gladly join in the "God, I hope this goes away" group...

 

[Bobby B]

I think that an increase T is a good sign of inner ear healing - whenever I got a T spike - sometimes really loud and for hours/days after doing LLLT a few days later my T went even lower than before and sound quality improved.

I would be disappointed if there were no T spike.

T spikes are pretty common in the healing process provided healing is taking place.

Its going to be ups and down before it goes quiet for good.

One guy who did the AM wrote that his T was much louder for a full month before going off completely.

 

[Nirav]

I have hight frequency hearing loss and tinnitus. Will AM - 101 help me?

 

[Dennis_De_S]

I am close to a complete breakdown by now. This has been very different from my phase III experience so far.

The T increase in my right ear is far beyond what I usually get when I block my ears i.e. use ear plugs for a long period of time. I would rate it at 8/10. I can hear it in the shower, the train, when driving my car, etc. It keeps me from sleeping and eating. Furthermore, it has developed some sort of reactive character, especially when I switch on the TV or try to listen to some music, it gets amplified.

So I gladly join in the "God, I hope this goes away" group...

I had the same thing going on bro, my T went skyrocket for 3-4 days then it was like more silent than before the injections for 2 days before it spiked again for a day.

 

[TC426]

Thanks for the support. It keeps me from totally losing it - for now.

I went back to the clinic earlier today, and explained my situation. They took my concerns seriously, but there was not much they could do after all. So far, they assume that it is just a strong side effect from the treatment and that they have no reason to believe that this would not be temporary.

However, I just cannot help that my brain keeps spinning in a loop with toughts like these:

• Why such a severe increase (3/10 --> 8/10)? Why this time but not last time?
• Why only the right ear, while the other one, which got the same treatment seems fine?
• Did the use of the suction device after gel was injected cause any lasting damage to my right ear. Is it related to the spike or is it a coincidence?
• Will this settle and go back to normal if I just sit and wait, or am I losing valuable time waiting?

I think the past 48h have been the most intense in my life so far. I have never been this frightended before...

 

[Cillian]

@TC426 can you mask it right tv radio etc ?

 

[lonestar651]

Thanks for the support. It keeps me from totally losing it - for now.

I went back to the clinic earlier today, and explained my situation. They took my concerns seriously, but there was not much they could do after all. So far, they assume that it is just a strong side effect from the treatment and that they have no reason to believe that this would not be temporary.

However, I just cannot help that my brain keeps spinning in a loop with toughts like these:

• Why such a severe increase (3/10 --> 8/10)? Why this time but not last time?
• Why only the right ear, while the other one, which got the same treatment seems fine?
• Did the use of the suction device after gel was injected cause any lasting damage to my right ear. Is it related to the spike or is it a coincidence?
• Will this settle and go back to normal if I just sit and wait, or am I losing valuable time waiting?

I think the past 48h have been the most intense in my life so far. I have never been this frightended before...

Hey Bud just had my second round of injections Monday through Wednesday. Today is the second day after them. I would not worry about it thats exactly what happened to me the first time and this time. The T spikes from a 4-5 to basically a 10. It is unbearable and I struggle to deal with it but I know it will get better. Last time it took me a week for the T to lower and two weeks to completely recover and have clear ears. Also for everyone interested in AM101 I am sorry to say it is too late to sign up they completed enrollment a few weeks ago.

 

[lonestar651]

Oh yea by the way I had the suction both times I do not think that had anything to do with it. The suction did not bother or spike my tinnitus. It was spiked as soon as the Gel was injected just like the first time.

 

[Dennis_De_S]

Thanks for the support. It keeps me from totally losing it - for now.

I went back to the clinic earlier today, and explained my situation. They took my concerns seriously, but there was not much they could do after all. So far, they assume that it is just a strong side effect from the treatment and that they have no reason to believe that this would not be temporary.

However, I just cannot help that my brain keeps spinning in a loop with toughts like these:

• Why such a severe increase (3/10 --> 8/10)? Why this time but not last time?
• Why only the right ear, while the other one, which got the same treatment seems fine?
• Did the use of the suction device after gel was injected cause any lasting damage to my right ear. Is it related to the spike or is it a coincidence?
• Will this settle and go back to normal if I just sit and wait, or am I losing valuable time waiting?

I think the past 48h have been the most intense in my life so far. I have never been this frightended before...

First time injections I also did not have it, Only second time the sound went skyrocket and it wen't completely away so stop worrying bro, have some faith.

 

[Hopeful1]

I am having my first injections (AM 101 ) on Monday.....is there any need to take someone with me?

 

[papu]

@Hopeful1 not really

 

[Charlie396]

@TC426 how are you doing now?

 

[TC426]

@TC426 how are you doing now?

Friday evening it felt like there was a jackhammer in my head - absolutely unbearable. Saturday started better and I spent the whole day outdoors on the bike to take the attention away from T. Today same story, was outside most of the time. One severe spike during last night which woke me up, but was gone until the morning.

I think the worst part is over. Right ear is still significantly elevated, but now down to 5/10 on average, 6 /10 max. (baseline was 2...3/10). Left ear seems fine, same as after TACTT3. Hearing is still muffled.

Office tomorrow, let's see how this goes (usually I have increased T during the day when I am at the office).

Thanks for the support to all!!

 

[Charlie396]

Shit, sounds like a few of us are trying to weather storms. Stay strong is I guess all we can do. I kinda wish past participants would make appearances here and there and give 'I went through similar experiences but things are gonna be ok' pep talks.

 

[Nick86]

I have been wondering about the same. Managed to convinced the doctor to not use the device for my set of injections yesterday, but simply dry it with a tissue instead. Thought I got away with it for this round, but during the 2nd set today, they somehow hurt my eardrum, which then filled with blood. For cleaning it up, they used the suction device with a felt volume of approx. 130...140dB, so extremely loud. Because of that, I have had a signifant spike in my right ear for the past 3h and am praying that it will go back to normal soon.

Interesting because after the first injection in each ear I was given the option of going without any numbing agent. So they just went in with the needle without any numbing, suction, etc. They said they are only required to use the numbing agent for the very first injection and after that it's optional. It was a big relief for me.

 

[Sebastians]

This friday i have my last follow-up check at the hospital after the first round of injections (had these in the last week of february, so it Will be about 2 months and 2 weeks after procedure).
Was there any improvement in the long run? I believe so. Wether this is due to getting am-101 and not the placebo is open for debate. I belong to the post-acute group and was about 5 months + in when i got the shots.
Before injections, my T would start at a 2/10 in the morning (rarely 1/10) and ramp up to a 5 throughout the day, sometimes a 6/10, where it seemed my whole head was buzzing by the evening and could hear it over a fan basically. I also did get a lot of fleeting T, let's say twice a week. Now i get softer fleeting T maybe once every two-three weeks.
Now i wake up to a 3/10 and it stays that way more or less the whole day, maybe a short spike up to 4 once in a while or a drop to 2/10. The 'whole head buzzing' part is definately gone and my T moved from the front left part of my brain more towards my left ear. In the beginning, when my T was masked by wind or road noise for example, i could actually 'feel' the hyperactivity in my left frontal lobe, weird...
My T is far less reactive and my mild 'painless' H has improved heaps lately. I don't pick up sounds anymore from buzzing lamps and electronics. Beeps at the supermarket sound less startling and i am less and less phased by clanging sounds (keys, metal, chains) and screeching car breaks. I still protect my ears when i go to loudish environments and wear 15db filtered plugs in certain stores, the gym if it's loud, on the tram or metro (i measured spl levels up to 90 db yesterday when on the tram!) or when having to walk next to busy roads (lorries, buses, honking etc). The plugs don't block out too much sound, but definately take the edge off. I don't wear ear protection when i'm chilling out in a park or hiking but try and stay under 65-70 db for longer periods of time.
M sleep has improved heaps as well. Especially in the last few weeks i have been sleeping better and better and not waking up to my T. Nor do i have the INSANE T-spikes at night when i was about 2-3 months in. Also, i haven't had to take any occasional sleeping med or melatonin since three weeks in a row now. I do not mask at night or anything, i just open the garden window for mild ambient sounds at night.
Could be natural healing, am-101 or a combination of both..
Been going to the gym lifting or doing cardio, taking supps and green smoothies eating lots of fish and health food. Cut down on alcohol and salty foods.. I believe all this contributed massively.
This being said, my T still bums me out a lot and there's moments i feel like i got half my life back, but not quite there yet.
Will i go for the open label? I'm stil undecided! I will be almost 8 months in when i will have the chance to get the shots and i don't think it will do much for me anymore and i am not willing to risk any complications at this point.

Ps. My audiogram is improving with time as well, last audiogram made at the hospital was MUCH better than the ones taken in the weeks after my acoustic trauma. I will post them after friday.

 

[Hopeful1]

I just had my first of the first round round of am 101/ placebo...i got from mild H and T from a salsa party 6 weeks back.....i could not tell if it is left or right ear as i hear it in the brain so went for..but i suspect its my right ear.....

Is there any way to tell if i got the Am 101 or placebo?

 

[AlexSongitus]

Thanks for the support. It keeps me from totally losing it - for now.

I went back to the clinic earlier today, and explained my situation. They took my concerns seriously, but there was not much they could do after all. So far, they assume that it is just a strong side effect from the treatment and that they have no reason to believe that this would not be temporary.

However, I just cannot help that my brain keeps spinning in a loop with toughts like these:

• Why such a severe increase (3/10 --> 8/10)? Why this time but not last time?
• Why only the right ear, while the other one, which got the same treatment seems fine?
• Did the use of the suction device after gel was injected cause any lasting damage to my right ear. Is it related to the spike or is it a coincidence?
• Will this settle and go back to normal if I just sit and wait, or am I losing valuable time waiting?

I think the past 48h have been the most intense in my life so far. I have never been this frightended before...

I wouldn't worry about the switching of the ears just yet. My T was always dominant in my left ear, and nearly inaudible in my right before the injections. After one injection they completely flip flopped. My left ear was completely silent, the entire day, but my right was louder than ever. After the next injection it completely reversed again, with my left ear loud, and my right ear completely silent. Then after that they were both the exact same level and I developed a pleasant centralized head sound that lasted for more than a month before it returning to my usual left ear dominance.

So at least on the part where things are switching, I think it's common. Nothing out of the ordinary.

 

[Nirav]

I need some information. Is AM - 101 for tinnitus or it will cure hearing loss?

 

[Hopeful1]

Its for tinnitus not for hearing loss......steroids like prednisone are used for hearing loss

 

[Hopeful1]

I had 2 days of injections(out of 3) of AM 101 or placebo.

Is there anyway that we can guess if we got the AM101 or placebo?

I just have increased perception of T and H as ears are stuffed and i have a hole in the ear drum.

Does anyone know how long it takes for the medicine to show improvement?

 

[linearb]

You should not really attempt to figure this out; basically you're trying to unblind yourself. If subjects are unblinded during a research attempt, it invalidates the data being collected.

Turning AM-101 into a proven, useful therapy depends on getting good, valid data out of these trials.

 

[Vaba]

linearb is right about unblinding yourself being a bad idea. But if you really need to satisfy your curiosity, I'd try reading other users' experiences and seeing if anything they experienced is like what you are going through.

Just search AM-101 in the search bar in the upper right. I may be wrong but it seems to be a general consensus that the effects are most felt over time, AM-101 does not seem to have an instant effect.

You also should have posted this in the support section - created threads in the treatment section is for the introduction and discussion of the efficacy of treatments new and old.