AM-101 Clinical Trial — Participants Updates and Discussion

[OddV]

Congrats on your journey and thanks for documenting it so thoroughly here!

Going to try audio notching or ACRN to try and knock out the last little bit.... Guess I'll write up a success story around my 1 year.

 

[Bertman]

Might have to consider giving this treatment a shot. There is a place 2.5 hrs away and I have had T for about 1 month now. I live in a fairly small city in canada and there seems to be no real other treatment available to me besides TRT. I've read about this a lot but I can't quite decide whether this treatment is an overly positive one with only 6 out of 18 seeing any improvement at all. I guess this could be that some had the placebo, but still.. Opinions?

 

[Danny Boy]

Today is turning out to be very different than other days. The electrical buzzing sound is mostly gone and the intense ringing that went on for over a week lowered today. It got a bit loud and stressful at work this morning and it ramped up a bit, but calmed down this afternoon.

I am sitting in a quiet room (48 db) trying to figure out what it is doing now. I have a variable tone that sounds like a quieted electrical buzz that changes every few seconds. I compare it to a mosquito buzzing around my ear. I also have some other noise that I am trying to concentrate on that I can't quite put my finger on. Imagine the rumble sound you would hear in a very quiet room before you had your tinnitus, but much louder.

If I took out the softened electrical whine this would be one of the quietest moments I have experienced since my incident. I also feel that my hearing is a little muffled in the one ear. Tomorrow I have my ten day checkup.

Unfortunately, my ringing seems to adjust to the environment. When the room gets loud, my ringing gets loud.

Sounds like reactive tinnitus.

 

[EarsKid]

Sorry for the late reply guys.

I am in the final stage. Last follow up appointment is in 2 weeks. Just wanted to relay that the treatment did not work for me. I believe my tinnitus to be noised-induced (playing headphones loudly on max everyday for at least 20 minutes). Further, I entered the trial just 1 week after exposure. So if the placebo was the real drug, it definitely should have worked.

Even after taking the real drug, no positive results that I can discern. Tinnitus is louder on my right ear compared to it being balanced prior to the trial. But I do not know if that's a result of left ear tinnitus getting lower so yeah.

As for how I am dealing with tinnitus... It honestly doesn't bother me. If I become conscious of it, which is probably once or twice a day (usually while resting) it is easily replaced with other thoughts.

 

[EarsKid]

Also, am I the only one who found the loudness matching test impossible? I did my best, but it was subjective that I could not tell if it was masking it or not.

Oh and yes the matching test is absolutely ridiculous IMO. I just don't know how they expect you to contrast the loudness of two completely different sounds.

@Romain B.

@EarsKid
I remember you and your spiritual point of view about T ! How are you now ? Still in the am-101 process ? Did you do the 2nd round ? And the 3rd round ? Please give an update !!

Hey man, sorry for not getting back to you sooner. Tinnitus is still present but I am doing VERY well. Back to life as usual.

 

[bellringer]

Sorry for the late reply guys.
Even after taking the real drug, no positive results that I can discern. Tinnitus is louder on my right ear compared to it being balanced prior to the trial. But I do not know if that's a result of left ear tinnitus getting lower so yeah.

As for how I am dealing with tinnitus... It honestly doesn't bother me. If I become conscious of it, which is probably once or twice a day (usually while resting) it is easily replaced with other thoughts.

On the 1-10 loudness scale you had to answer every night what value would you place on it? My goal is just to get the volume lowered to perhaps a 4. Anything lower is a gift. My baseline is a 6-7 and that is pretty impacting.

 

[erik]

@shantelle

I can't say.. I don't know.. Maybe maybe not, it' s so foggy cause my T is still here but i don't know what part is to the drug and what part is to habituation ...

This is very interesting because I believe many people with T can habituate within the first few months or sooner (though it took me 1.5 years or more), so that is a good question with a lot of these trials - how much does the drug actually help vs the natural habituation that would take place anyway? I believe this will ultimately always cause flawed results. Unless there is a drug created/tested which completely irradiates the T or makes such an impact that it is dramatically noticeable, then there will always be mixed results.

 

[EarsKid]

@grandfunk1
@EarsKid
I remember you and your spiritual point of view about T ! How are you now ? Still in the am-101 process ? Did you do the 2nd round ? And the 3rd round ? Please give an update !!

Hey man, sorry for not getting back to you sooner. Tinnitus is still present but I am doing VERY well. L

Oh and yes the matching test is absolutely ridiculous IMO. I just don't know how they expect you to contrast the loudness of two completely different sounds.

On the 1-10 loudness scale you had to answer every night what value would you place on it? My goal is just to get the volume lowered to perhaps a 4. Anything lower is a gift. My baseline is a 6-7 and that is pretty impacting.

Placing a number has always been difficult to me because I don't know what to say it's relative to... but I'll take a shot and say it's around a 7.

 

[Zechariah]

This is very interesting because I believe many people with T can habituate within the first few months or sooner (though it took me 1.5 years or more), so that is a good question with a lot of these trials - how much does the drug actually help vs the natural habituation that would take place anyway? I believe this will ultimately always cause flawed results. Unless there is a drug created/tested which completely irradiates the T or makes such an impact that it is dramatically noticeable, then there will always be mixed results.

That's why they use placebo and bigger sample group in phase 3. This is usually enough to give statistically significant results if the drug works.

 

[bellringer]

Today is 17 days since my first injection (14 days since my final) and I can't say I am back to baseline yet. On day 4 and 5 I had some good moments when my tinnitus actually got pretty low at some parts of the day. I had some quieter moments on day 9. That was to be short lived as it cranked up and has been screaming all of the time.

 

[Stu]

Okay so I'll come out of the shadows and write something since the thread has quietened down recently... I've not updated before since I've had nothing to report.

I'm currently enrolled in the trial. I had the first round of injections 3 months ago and like many posters here assumed I didn't get the good stuff as they made no difference whatsoever.
Started second round last week, now on day 8 and am in the middle of that horrible spike period but will report back in a couple of weeks to update on any changes etc. once everything calms down again.

Now for the interesting part... I did meet and speak with someone else at the trial clinic who stated that they had no responce to the first round but DID experience a significant reduction around 3 weeks after starting round 2 (they were at the clinic for a 3rd round as a result of this.) I'm not going to hang any significant hope on this as everyone reacts differently to the drug but thought I'd share a positive story that otherwise wouldn't have reached the forum.

Anyway fingers crossed!

 

[Hoser]

Hi all,
First post. I suffered significant hearing loss in one ear, mild in the other and subsequent tinnitus last October at a concert I was playing at. The first couple months I went through a bout of "significant emotional distress" as my doctor aptly put it, couldn't sleep, couldn't work, couldn't function...I was on prednisone with little relief. A number?? about a 7/8 on loudness. I enrolled in the study and had my first injections in January. While I'm a fairly level headed, low stress guy, I was scared to death. Same questions as all others; Will it get worse? Will I lose more hearing? etc. Had a big spike for about 3-4 weeks and was in a panic wondering if I made a mistake. It settled down to about 5 for the one month follow up. By three months, its was down to 5ish and I was feeling a bit better. I did the second round and suprisingly, the spike lasted 6 days and settled down to a 2 or 3. I made a commitment not to give it anymore emotional real estate as well and it was a great 3 months...back to a relative normal. I decided to get the third round, which commenced a month ago. I had a monster spike for 18 days after and began to panic, wondering if it was a mistake. I woke up on day 19 and it was a soft 2. I get little spikes when I'm tired, driving over significant elevation changes (I live in BC), or a little stressed, but overall, I rarely hear it. If I get a small spike, I know it will disappear. I have custom hearing protection on me all the time for the movie theatre, cutting the lawn, etc., and no more plugged in live concerts, so there has been some adjustment, but at the end of the day, I am THANKFUL I went through the treatment. To all who posted on this site, thank you for your input and comforting words...got me through some difficult days. For those who are unsure about starting or continuing, I understand the anxiety. Despite that, I would strongly suggest that you do it. I am back, healthy, happy, and looking forward to most things life has to offer. You will have difficult times, question your decision, and most likely, turn to this board for words of comfort. I hope this helps. BTW, no forth injections. While the T will always be somewhere in the background, I can't see it getting much quieter. Hope this helps.

 

[Stu]

Hi all,
First post. I suffered significant hearing loss in one ear, mild in the other and subsequent tinnitus last October at a concert I was playing at. The first couple months I went through a bout of "significant emotional distress" as my doctor aptly put it, couldn't sleep, couldn't work, couldn't function...I was on prednisone with little relief. A number?? about a 7/8 on loudness. I enrolled in the study and had my first injections in January. While I'm a fairly level headed, low stress guy, I was scared to death. Same questions as all others; Will it get worse? Will I lose more hearing? etc. Had a big spike for about 3-4 weeks and was in a panic wondering if I made a mistake. It settled down to about 5 for the one month follow up. By three months, its was down to 5ish and I was feeling a bit better. I did the second round and suprisingly, the spike lasted 6 days and settled down to a 2 or 3. I made a commitment not to give it anymore emotional real estate as well and it was a great 3 months...back to a relative normal. I decided to get the third round, which commenced a month ago. I had a monster spike for 18 days after and began to panic, wondering if it was a mistake. I woke up on day 19 and it was a soft 2. I get little spikes when I'm tired, driving over significant elevation changes (I live in BC), or a little stressed, but overall, I rarely hear it. If I get a small spike, I know it will disappear. I have custom hearing protection on me all the time for the movie theatre, cutting the lawn, etc., and no more plugged in live concerts, so there has been some adjustment, but at the end of the day, I am THANKFUL I went through the treatment. To all who posted on this site, thank you for your input and comforting words...got me through some difficult days. For those who are unsure about starting or continuing, I understand the anxiety. Despite that, I would strongly suggest that you do it. I am back, healthy, happy, and looking forward to most things life has to offer. You will have difficult times, question your decision, and most likely, turn to this board for words of comfort. I hope this helps. BTW, no forth injections. While the T will always be somewhere in the background, I can't see it getting much quieter. Hope this helps.

You sir, are an inspiration to anyone unsure about the AM-101 trials. Given the stage I am at with mine, your post was exactly what I needed to read. Thank you!

 

[Robb09]

Great post there, very encouraging, keep us updated so we arnt left in the dark. I want to join but Canada does not accept past 3 months and I just found out about it barely past the 3month T on internet, I wish the doctor or ent mentioned about it but guess they are clueless...

 

[ring a ding]

https://clinicaltrials.gov/ct2/show/NCT02040194

I was accepted for the study but I'm cancelling my participation because my tinnitus has improved dramatically over the last two weeks as my inner ear infection is on the mend. The main requirement is that you must have gotten your tinnitus symptoms in the last three months and the tinnitus must be continuous and not intermittent.

 

[bellringer]

An update for those watching my progress. Yesterday I had my 35 day checkup. I finally returned to baseline on Saturday, August 15. That is one month after I received my first injection. I believe I got the real drug the first time around as about 20 minutes after the injection part of my face was numb, and I was a little high for about two hours.

I have to say that my ringing seems to have gotten more high pitched, but it doesn't seem to be bothering me as much. This could be that I am getting use to the condition as I am close to three months since my acoustic incident. My baseline is 6-7 in loudness, and during the post injection period I was at an 8.

 

[Stu]

An update for those watching my progress. Yesterday I had my 35 day checkup. I finally returned to baseline on Saturday, August 15. That is one month after I received my first injection. I believe I got the real drug the first time around as about 20 minutes after the injection part of my face was numb, and I was a little high for about two hours.

I have to say that my ringing seems to have gotten more high pitched, but it doesn't seem to be bothering me as much. This could be that I am getting use to the condition as I am close to three months since my acoustic incident. My baseline is 6-7 in loudness, and during the post injection period I was at an 8.

So it's quite subjective then as to whether there is any difference as a direct result of the drug?
I'm on day 19 of round 2 and I'm still not back to baseline yet.

 

[Hugo]

Hi everyone.. New to this forum.

I've had Tinnitus since a week back from noise trauma (unfortunately enough, and I kid you not, from an extremely loud parrot) and I fear that this may become permanent. I am from Sweden and I was wondering if there is any way I can take part in this study despite this? Does anybody know what I should do, or who I should contact? Any information would be greatly appreciated. I'm only 19 years old and I fear that this may be my only chance before this becomes chronic and I'd take any chance I'd get.

TL DR; From Sweden.. Can I still partake in the clinical trial?

 

[bellringer]

One thing that caught my attention is some people who had some hearing loss in the first 30 days had improvement from the drug. Except for my 3rd injection my hearing cleared within an hour of injection. I had no hearing loss at the 10 day checkup.

I am thinking that maybe the drug was never able to get into my cochlea. Perhaps that is why I cleared up quickly and had no hearing loss. I was looking at a photo my wife took of me during the 30 minute waiting period and my head was only tilted perhaps 25 degrees, instead of 45 degrees. Some sites have you lay down with a pillow, but mine has me sitting in a chair during the waiting period. I asked the doctor at the time about it and he said the tilt was fine. I am thinking most of the drug went down my throat.

This drug might work, but only if it soaks into the cochlea.

 

[markoana]

One thing that caught my attention is some people who had some hearing loss in the first 30 days had improvement from the drug. Except for my 3rd injection my hearing cleared within an hour of injection. I had no hearing loss at the 10 day checkup.

I am thinking that maybe the drug was never able to get into my cochlea. Perhaps that is why I cleared up quickly and had no hearing loss. I was looking at a photo my wife took of me during the 30 minute waiting period and my head was only tilted perhaps 25 degrees, instead of 45 degrees. Some sites have you lay down with a pillow, but mine has me sitting in a chair during the waiting period. I asked the doctor at the time about it and he said the tilt was fine. I am thinking most of the drug went down my throat.

This drug might work, but only if it soaks into the cochlea.

that is catastrophic if that doctor (and who know how many others) are so uneducated! Maybe u should send a mail to the central research board of am101...

 

[bellringer]

that is catastrophic if that doctor (and who know how many others) are so uneducated! Maybe u should send a mail to the central research board of am101...

I hate to second guess the doctor as he understands the procedure better than me. For all I know it may not make a huge difference. I have a photo my wife took of me in the chair after my first injection and I am not tilted much. The first two injections I cleared up after about an hour, but the 3rd and final one of the series took a couple of days which is probably a good sign that it made it in.

 

[bellringer]

A quick progress report. I am at day 42 since my first injection and I feel like things have gotten a little bit better. At day 30 there was a sudden change when my tinnitus stopped being so reactive to sound and I returned to baseline. After my Day 35 hearing test I ramped up a little loud for a day as the hearing tests seem to lead to louder tinnitus. Last Sunday was my quietest day since getting this infliction. Monday was not quite as good, but today is going pretty well. I don't have such a huge frequency variation like I had during the first month post injection.

My baseline was a 6-7 loudness, equal annoyance. After the injection I was 7-8, mostly 8. Last Sunday I put a 5 down on my diary, yesterday was 6, and today is somewhere between 5 and 6. This is on a 1-10 scale, with 10 being loudest.

While it seems like baby steps, it is a big deal to me. When I start hitting 7 and 8 is when I turn into an emotional mess. If I was there permanently I would be thinking about going on drugs to cope. However, a 5-6 is something I could learn to live with. The improvement could be a result of tinnitus running its course, or it could be the drug. If the drug is working I should continue to see gradual improvement over the next 6 weeks.

 

[Bertman]

A quick progress report. I am at day 42 since my first injection and I feel like things have gotten a little bit better. At day 30 there was a sudden change when my tinnitus stopped being so reactive to sound and I returned to baseline. After my Day 35 hearing test I ramped up a little loud for a day as the hearing tests seem to lead to louder tinnitus. Last Sunday was my quietest day since getting this infliction. Monday was not quite as good, but today is going pretty well. I don't have such a huge frequency variation like I had during the first month post injection.

My baseline was a 6-7 loudness, equal annoyance. After the injection I was 7-8, mostly 8. Last Sunday I put a 5 down on my diary, yesterday was 6, and today is somewhere between 5 and 6. This is on a 1-10 scale, with 10 being loudest.

While it seems like baby steps, it is a big deal to me. When I start hitting 7 and 8 is when I turn into an emotional mess. If I was there permanently I would be thinking about going on drugs to cope. However, a 5-6 is something I could learn to live with. The improvement could be a result of tinnitus running its course, or it could be the drug. If the drug is working I should continue to see gradual improvement over the next 6 weeks.

Good to hear, I'm interested in trying to get into the trial myself as I seem to fit the bill, but am quite worried about the possibility of having a permanent increase. Hope you do well in the next few weeks and have some quiet time!

 

[bellringer]

Good to hear, I'm interested in trying to get into the trial myself as I seem to fit the bill, but am quite worried about the possibility of having a permanent increase.

If you read over the previous study results you will see some reported it getting worse. However, we don't know the circumstances of those increases. It could have been caused by an ear infection following the procedure. My trial doctor told me that if I did not have a history of infections then odds are I would come through this without trouble.

I had the same panic going into mine, to the point where the trial almost rejected me on injection day. It was such a hard decision because I was so loud, and having to make a decision for something that could make it worse was causing my anxiety, which made my tinnitus worse.

If you are going to enter the study do it sooner than later as some of us have a hunch that earlier intervention from onset has better results than one later.

 

[Bertman]

If you read over the previous study results you will see some reported it getting worse. However, we don't know the circumstances of those increases. It could have been caused by an ear infection following the procedure. My trial doctor told me that if I did not have a history of infections then odds are I would come through this without trouble.

I had the same panic going into mine, to the point where the trial almost rejected me on injection day. It was such a hard decision because I was so loud, and having to make a decision for something that could make it worse was causing my anxiety, which made my tinnitus worse.

If you are going to enter the study do it sooner than later as some of us have a hunch that earlier intervention from onset has better results than one later.

Yeah I have read pretty much everything I can on the subject. I do not have a history of ear infections but who really knows what could've caused those increases. I agree the sooner the better, but it's just such a hard decision. I don't want to regret doing it if it causes an increase but I also don't want to regret not doing it and missing out on an opportunity to lower my T. The future is scary..

 

[OddV]

@Bertman I had the same struggle all 3 times I did it. For me, looking back on it, I think it helped in my situation.

 

[Sharpfire]

Had round 1 in June, and it's likely that I'm getting the real thing on Tuesday. Tinnitus level feels unchanged, annoyance is way down tho - probs just habituation or whatever it's called. Hopefully, the second round reduces the volume as well!

 

[Stu]

Like I said in my post I'd update within a couple of weeks and I intend to keep the thread updated on my progress…

The unfortunate news I'm afraid is that at this stage I can offer nothing positive - It's now day 27 and this second round (first 100% guaranteed dose open label) of AM-101 has made absolutely no difference to my tinnitus. I think if it was going to provide me with any relief it would have kicked in by now so a huge disappointment for now.

Despite not having any positive outcome, (and again as posted previously) I met someone else at the trial centre who had got their second round and it made a huge difference so I think it does work but just not on everyone.

Am I back to baseline? Well yes and no… before baseline my tinnitus fluctuated between a 6 and an 8, I feel over the past few days I've been at an 8 but it's still stuck on that and hasn't gone any lower. Fingers crossed that I start getting the odd quieter day in the next few weeks as before (I won't panic unless I'm still stuck on an 8 beyond week 6.)

If I do go back to baseline properly then I MAY even consider another round of the open label real thing like @OddV just to be sure but I don't really know for certain at the moment… failing that I'll wait for AUT00063 to hopefully go to phase 3.

Sorry I can't offer anything better folks.

 

[Dave111]

wasnt it 1/2 of the participatians got a plasebo?

 

[Stu]

wasnt it 1/2 of the participatians got a plasebo?

40% Placebo
60% Real Drug