AM-101 Clinical Trial — Participants Updates and Discussion

[AlexSongitus]

Have been thinking about this and my only concern is, if they can wipe their ass with the initial agreement, maybe they can also give placebo in the open label round just to save some pennies...

If they are limiting the rounds in some areas, I really do not think they are doing that to save money on the drug. The cost isn't in the drug. If they are even doing it for cost reasons, then it's most likely in the fact you are having doctors and their assistants, billing them for all the hours the injections and follow up appointments take. In my case 2 doctors, one of which is a renowned ear surgeon and I imagine he doesn't work cheap. They have every reason to want to know what AM-101 really does at that time frame. Not to mention, it would be completely unethical, and probably illegal to inject your ears and lie about what they are putting in there. If it ever got out, they'd be toast.

Most likely they are finding out the drug is not effective that far out, and people are reporting more problems than help. The purpose of that study is to monitor what happens if they administer multiple injections. Maybe they are finding out it can cause problems to do too many rounds and are doing it as a safety measure. Or perhaps that when you are talking about monitoring people over the course of a year or more, it's hard to keep everyone following the rules and not have some put themselves at risk from sounds that might do new damage and worsen T over such a long time frame.

Whatever the case is, saving money on the drug itself, would be the last reason on my list. Especially lying about it too.

 

[liquefact]

some popping/crackling sensation in my left ear when swallowing

My popping in the ears went away only 1 week before 2nd injections, you're lucky dude.

 

[AlexSongitus]

Been absent for the last week, quite busy these days, so I am not sure if the following has been discussed in depth.

Getting back to the topic for the follow-up trials, I have been thinking about it, and gotta admit that I am feeling (and this is purely emotional) cheated by the new regulations. Not because I planned to participate in all rounds, but because of having the option if I want to. I signed a particiation agreement and adhered to all the agreements made, so I expect the same from Auris.

Does anyone know if there was a clear statement about these follow ups in the trial documents? I cannot remember where I stored those documents, so I cannot check it right now. In my case, there was a verbal commitment from the doctor for up to four follow up rounds (legally binding but hard to prove), but I am not sure to what extent it is reflected in the agreement.

Any advice from fellow participants?

Have you contacted any other centers close to you to see if it's just your study center that's telling you this? Have you tried contacting Auris Medical themselves? Because here in the US, I and other members have confirmed they are still doing all the rounds.

 

[Genevieve]

I have participated in the tact-1 and 2 of phase 3. I got got three injections after 2.5 months of T, and also received the real drug (3 months later) where I got 3 more injections. I regret my decision to take part in the trial after the second round and will not be participating in any more injections. My T went way up after the second round and almost came back down to normal. I got the injections in both ears. What has made it worse is that I hear fans and high frequency sounds differently now. I woke up 4 weeks after the second round and couldn't place a certain sound I was hearing. The things that gave me comfort now annoy me, total Hell. Before I went for round 2 I was starting to feel good about everything, I thought that I could live a normal life again. The second round definitely made my better ear worse and is worst than the other much of the time now. I hate to be debbie downer, but the only reason I joined was to share my experience. I hope that one day I can change my response to the survey but for now I am being honest and other people should know. It's a difficult decision to get the injections and if my hearing had not changed I probably wouldn't be regretting it so much. I know this will probably cause a stir so if you have questions please message me as there is a reason I can not go into much detail publicly. I'll do the best to share what information I can.

Thanks,

Mikey, I'm sorry to hear about your experience with the AM-101 trial, I don't know if your are still active on this forum, but I would like to know if you feel better now after 1 year? I didn't read all the post yet about the AM, that's what I am doing right now (56 pages! ,) but there is something I want to ask: I thought the injection was only in one ear and not both ears why did they give then back the drugs in both ears? It's already so stressful and painful to have the injection in one ear, so both it must have been awful for you

 

[Genevieve]

The saying goes: "...but in this world nothing can be said to be certain, except death and taxes."

If the statement by Benjamin Franklin is true, then everything else in life is assigned a probability between 0 and 1 (strictly speaking: 0 <= x < 1). Where on the "probability scale" the chance (= risk) of a "bad outcome" for the AM101-intervention falls, is something you need to decide for yourself. But the AM101 phase II trial results probably provide a fairly good indication (the trial paper has even interpreted the statistical results on behalf of the reader: "The study drug and I.T. injections were well tolerated").

The human mind has a tendency to "amplify" the probabilities of good and bad events (eg. winning the lottery, catching a disease). The current Ebola "crisis" in the US is a good example. I spoke with my Father a few days ago. He mentioned he had been to Spain with his wife and my younger brother. They - my Father's wife and brother - decided to cut the journey short because of the single Ebola-hospitalized nurse female assistant there (now released). If it wasn't so sad, I would have fallen over laughing - with cramps - because of that kind of decision making. A person going to any modern city in the world would have a greater chance of dying from Salmonella, a car crash, or slipping on a banana peel. But the human mind likes to draw attention to matters of fear: it is a survival instinct (from the past). But the survival instinct can also be(come) an enemy. The brilliant mathematician, Kurt Gödel, died from a fear of food poisoning. More specifically, he died from the fear that the food he was served in hospital would be infested with germs - he knew that all surfaces eg. tables, door knobs, and drinking glasses, and so on, would "automatically" be contaminated with germs. He starved to death because he wouldn't eat. He weighed only 30kg at the time of his death. Logically speaking, if you are going to die from starving, then why not take a chance and eat? After all, the worst thing that can happen is that... you die.

But the human mind is not logical and psychology is a part of any human being. The answer - if you want to call it that - to your original question is probably somewhat different than you had expected. I leave it - as an "intellectual exercise" - to figure out whether I think you should participate in the trial. Or not.

I think that Kurt Gödel the great mathematician your are speaking to must have suffered more from OCD than " a survival instinct from the past", like the great Howards Hugh ( who was brilliantly played by Leo Di Caprio in the film "the Aviator") In fact poor Howards was so scared to be contaminated with germs (wearing gloves at home constantly) that he ended up his life completely alone in his big home,

 

[liquefact]

Most likely they are finding out the drug is not effective that far out, and people are reporting more problems than help. The purpose of that study is to monitor what happens if they administer multiple injections. Maybe they are finding out it can cause problems to do too many rounds and are doing it as a safety measure. Or perhaps that when you are talking about monitoring people over the course of a year or more, it's hard to keep everyone following the rules and not have some put themselves at risk from sounds that might do new damage and worsen T over such a long time frame.

I believe quite the opposite. They have enough data right now and as a cost cutting measure they're slowly terminating the trials. In US, they're stopping accepting new patients, in EU they're limiting the already existing 3 rounds to just one (not agreeing with your and other's comments though, giving the commitment for 3 rounds and changing the rules in game is not nice).

They have to prep up for FDA application and to the other committee's in the world. For this, as far as i know, they have to stop the trial, shape all the data to a presentable way and etc. And it does not seem normal practice to continue trials and get an approval.

This is how i see it.

 

[AlexSongitus]

I believe quite the opposite. They have enough data right now and as a cost cutting measure they're slowly terminating the trials. In US, they're stopping accepting new patients, in EU they're limiting the already existing 3 rounds to just one (not agreeing with your and other's comments though, giving the commitment for 3 rounds and changing the rules in game is not nice).

They have to prep up for FDA application and to the other committee's in the world. For this, as far as i know, they have to stop the trial, shape all the data to a presentable way and etc. And it does not seem normal practice to continue trials and get an approval.

This is how i see it.

Huh? I don't think that's cool either.

 

[medal]

I'm in doubt with the following...
Can I say that my tinnitus is caused by a perforated eardrum because of an hand smack on my ear? Or would I be disqualified if I said so? Does only noise induced tinnitus count?

Auris states a traumatic perforation of the eardrum in there list of options so I assume i won't disqualify... Just want to be sure

 

[Alue]

I'm in doubt with the following...
Can I say that my tinnitus is caused by a perforated eardrum because of an hand smack on my ear? Or would I be disqualified if I said so? Does only noise induced tinnitus count?

Auris states a traumatic perforation of the eardrum in there list of options so I assume i won't disqualify... Just want to be sure

Where do you live (country)? I don't think they are accepting any new applicants in the US, I'm not sure about elsewhere.

 

[Hotaru]

Two week update: My T is slightly lower than when I first got the AM-101, used to be a 10 and is now 7-8. The ETD is in remission, but I have tons of earwax and my jaw still hurts from time to time.

I get these moments of either deafness or the T changing or disappearing (I can't tell because they are too fast) I'm pretty sure it's the latter; the audiologist said my hearing was normal at the 10-day visit. Does anyone else get these?

Even though it's lower, it's not enough. The trial is far too long. I need to do something else to try to get rid of the ringing. The waiting is torture, and the drug will most likely not work by the time end of May, beginning of June comes around.

 

[Aussie Lea]

The ETD is in remission, but I have tons of earwax and my jaw still hurts from time to time.

How did you treat your ETD? (Sorry for going a bit off topic)

 

[Hotaru]

How did you treat your ETD? (Sorry for going a bit off topic)

I didn't. It went away on its own.

 

[Bobby B]

Well if t was caused by ETD / wax and ETD is getting cured on its own so how would we know if am-101 had anything to do with this ?

 

[adrian_em]

Anyone can tell me if this trial is still running in Europe? And about a possible final result such as a commercial medication?

 

[matt89]

Anyone can tell me if this trial is still running in Europe? And about a possible final result such as a commercial medication?

The phase III of the AM-101 clinical trial is still running in Europe (http://tinnitus-study.info) and will end in the fourth quarter of 2016. According to a statement of Auris Medical a commercial medication can be expected in 2017 if the results of the current phase III of the clinical trial (TACCT3) are satisfactory.

 

[noisebox]

I think all people experiencing T have a sort of depression...mild or severe. I've never seen a guy with T being happy of this state...

I have my dad, if you say do you have T, he says " ah yes now you mention it I perceive it". He is very deaf too, very happy and the T does not bother him one jot.
There is evidence to suggest that those of us in distress with T process sound in a different area of our brains to those who are not distressed. They have seen it on MRI

 

[Mario martz]

1 week update
2 weeks update:

Trial:
AM-101 initial trial

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 injections:
Left ear: 3/10
Right ear: 1/10

Tinnitus description before injections:
Hissing in both ears, slightly different frequencies. Loudest in the mornings.

Date of injections:
3/2/2016-3/4/2016, 1.5 months since onset

Have you felt any change/improvement/worsening since the injections?
Yes. Yes. Not anymore!

After a 2nd week, I can definitely say I'm noticing a significant improvement. I was actualy getting disheartened towards the end of last week after I had those amazing days of silence on day 1 and day 3 after injections and then it settling lower, but not silence, towards the end of last week. Thought it would just end up settling at a lower volume, but that the silent phase was over for me. Well I'm happy to report that has not been the case and I have noticed continued improvement. I have had silence for at least 4 hours or longer for the last 4 of 7 days, including today. I have constantly woken up with very low T. Last Saturday was the last day I reported my T as a 2 when I wake up. Every day since has been a 1. Prior to the injections, morning were always loud and my loudest T was in the morning. Most importantly, I was getting used to having a loud day, after experiencing silence. On one occasion this week I actually went to bed in silence, and woke up in the middle of the night still in silence. Never happened before since sleep always reset mine. This was a great sign to me. Yesterday afternoon until about 4am this morning I had silence, and even though I woke up with it at a 1 today, I'm in silence right now and has been fluctuating between 0-0.1 for about the past 4 hours. Never had silence 2 days in a row. My T has never gone above my baseline even once this week, I have reported baseline on 3 occasions on 3 different days(~12 hours total in the past week). Other than that it's been a 2, and more often a 1. Centralized sound as opposed to hissing.

These are my last 7 days tracking from my spreadsheet including today:
NT = not tracked.

Wake up/Morning/Afternoon/Evening/Night
03/12 Left ear: 2/1/1/0.5/0 Right ear: 2/1/1/0.5/0
03/13 Left ear: 1/1/2/2/3 Right ear: 1/1/2/2/3
03/14 Left ear: 1/1/0/0/0 Right ear: 1/1/0/0/0
03/15 Left ear: 1/1/2/2/3 Right ear: 1/1/2/2/3
03/16 Left ear: 1/2/2/3/2 Right ear: 1/2/2/3/2
03/17 Left ear: 1/1/0/0/0 Right ear: 1/1/0/0/0
03/18 Left ear: 1/1/0/NT/NT Right ear: 1/1/0/NT/NT



Current T severity and average T severity over the past week:
Current: Fluctuates between 0-0.1. I say that because if I listen hard for it every minute or so I can faintly hear something. I can't even rate it a 0.5
Average over the past week: 1.5 Honestly at this point it's easier to tell you when it bothered me. Just on the 3 days during the hours I rated it as a 3. I'd say 90% of this past week my T has been a non-issue.

Do you believe that you got the real drug or the placebo?
Yes, at this point I'm pretty sure I did.

Have you experienced any lasting (side) effects from the procedure?
No. If I was to be completely anal, and list absolutely every little thing I noticed this entire week, then I got some water in my ear today and I felt pain for 10 seconds which I thought was strange. Maybe it was more in my head than reality, because I was paranoid about it. That's it!


Will you participate in the next round?
If it's still there, yes. I hope this trend continues and I won't have to.


Edit: One more thing I should mention. Since the sound has become centralized in my head, more of a low sizzle than a hiss in my ears, even a T of 1 is a major improvement over my T of 1 when it was a hiss in my ears. When it was still coming from my ears, it felt more annoying, because it was affecting my hearing and made me feel more unbalanced, or like I wasn't myself. The days it was a 3, and annoyed me, it was hissing in my ears.When it's centralized in my head, it feels like I am normal again, because my ears feel normal, and you get the sensation that your hearing is not impaired in any way, and your ears are actually silent and that there is nothing wrong with them anymore. It's extremely easy to ignore it like this. So even at the same level loudness, it's a significant improvement on the annoyance factor due to it shifting to this new centralized sizzle. Hope that makes sense.

This give me so much hope!!

 

[Mario martz]

The phase III of the AM-101 clinical trial is still running in Europe (http://tinnitus-study.info) and will end in the fourth quarter of 2016. According to a statement of Auris Medical a commercial medication can be expected in 2017 if the results of the current phase III of the clinical trial (TACCT3) are satisfactory.

Great! it seems like a possible cure is on the way

 

[Meg0]

According to a statement of Auris Medical a commercial medication can be expected in 2017 if the results of the current phase III of the clinical trial (TACCT3) are satisfactory.

Hi, could you tell me what is meant by a commercial medication?

 

[matt89]

Hi, could you tell me what is meant by a commercial medication?

It means that intratympanic injections with the substance of Esketamine hydrochloride (0,87 mg/ml) will be available as another officially approved therapy option for subjetive tinnitus (especially during the acute phase).

 

[adrian_em]

The phase III of the AM-101 clinical trial is still running in Europe (http://tinnitus-study.info) and will end in the fourth quarter of 2016. According to a statement of Auris Medical a commercial medication can be expected in 2017 if the results of the current phase III of the clinical trial (TACCT3) are satisfactory.

It means that it will be to late for those of us who are still in the acute phase after acoustic trauma, right? This is what I read on their webpage that their treatment should be administered after being released in the first three months after the trauma occured. Or are they aiming also at larger amounts of time after acoustic trauma occurence? Anyone knows if a person from a country could participate at the trial in other country? I'm from Romania and I sent an email to a clinic in Hungary but I received nothing.

 

[matt89]

It means that it will be to late for those of us who are still in the acute phase after acoustic trauma, right? This is what I read on their webpage that their treatment should be administered after being released in the first three months after the trauma occured.

First thing. AM-101 does not guarantee any cure even if you receive the real substance.
We don't have any confirmed statements from people who got cured, but we have statements from people who have experienced smaller or bigger improvements. So this trial can be evaluated that a participation is worth it.
If you participate in the trial within the first three months after acoustic trauma and you receive the placebo (you have to find it out yourself), you can participate in another trial three months afterwards where you definitely receive the real drug. Then you're still in the post-acute phase (6 to 12 months) which means the chances to get an improvement are maybe a bit lower but not eliminated.

We don't know at this moment which effect Esketamine injections have on people with chronic T, because these people are not allowed to participate in the trial. Another question is when can a T be declared as chronic, this is also unclear from the medical perspective.

Anyone knows if a person from a country could participate at the trial in other country? I'm from Romania and I sent an email to a clinic in Hungary but I received nothing.

Unfortunately residents from countries where the trials do not take place are unable to participate in other countries.

 

[John D]

Hi All,
I'm from the UK and my on set of T was back in October 12th, My T has ranged between 3-8. I had 3 injections over 3 day's the last one being 15 days ago. I still have a bad constant spike of 7. Getting the felling that had the placebo. I have been told I can have the real am-101 at the end of May but the will be almost 8 months on .
Has any one had improvement after a long spike like me.
Also thinking how much It will help at 8 month on.

 

[adrian_em]

@matt89 thank you for your answers, I was aware that this drug does not guarantee complete cure, however I was hoping for it being released ASAP, whatever the chances it provides for improvement.

 

[medal]

Where do you live (country)? I don't think they are accepting any new applicants in the US, I'm not sure about elsewhere.

No I don't live in the US. As is been said before they are still accepting people in Europe, don't know if they still do in the US

 

[barnacle]

Let's not forget SF0034. It has my biggest expectation from current research so far.

Hi Hope your T spike has gone down. I was wondering about the A101 trial. Do you know at what stage they ask to see your medical records at your doctors and whether you are allowed to keep back info (on other illnesses) which is not relevant? Thanks for any help you can give on this.
Best wishes

 

[Sebastians]

@barnacle
I had my shots in Belgium. I could tell them whatever, they did not check my medical records at all. Dunno if that's just because i live in a failed state though

 

[John D]

@John D
Mine took a bit over two weeks to gradually subside. Got a bit panicky too after ten days, it's normal.
Just over three weeks now and it's still a tad louder than baseline and still some popping/crackling sensation in my left ear when swallowing. Give it time

Hi Hope your T spike has gone down. I was wondering about the A101 trial. Do you know at what stage they ask to see your medical records at your doctors and whether you are allowed to keep back info (on other illnesses) which is not relevant? Thanks for any help you can give on this.
Best wishes

After having my first assessment. Required 2 years notes from my GP. But I think the only thing that the Dr looked at was when my T started. P's still have the bad spike

 

[SkyGift]

Noise induced, it's on there now. I was on a very prolonged music session for 3 days with ear buds in my ears producing songs with FL Studio. They found me with about 40db loss in the 8k range I honestly can't really tell a difference from before T and after. I have a feeling not all that hearing loss came at that time when I got T, and probably most of it was over the course of my life. I highly doubt I had perfect hearing before T, since I have been playing loud rock music since I have been in my teens.

Thank you for your kind reply... I hope T left you completely very soon..

 

[AlexSongitus]

Thank you for your kind reply... I hope T left you completely very soon..

That would be amazing but I am not getting my hopes up. Maybe if my T naturally improves and the 2nd round continues improvement.

I will just give a quick update since I'm posting my full month update next week. This week was not as good as my 2nd week, only had 1 day of silence last Sunday, and since then the lowest it's been is 1 or not noticeable but still there. The first 2 weeks it was constant improvement in one direction, this week it took a step back, but still an improvement overall from before the injections. So week one was good, week 2 was amazing, now week 3 is just ok. Not sure if it means it settled here, which would mean a significant improvement, but not as good as last week. I practically didn't care about T at all anymore and had many hours of silence every other that I could practically call it intermittent T at that point. Tomorrow is going to mark a full week since the last day I had total silence, and I'm getting a bit anxious to find out if I'm going to have that again or not, and I'm just stuck with low T. We'll see how it goes the 4th week.

I'm still tracking it 4 times a day, and will do that until the end of next week to post my full 1 month report. At that point I look forward to stopping that, so I can just try to get my mind off of it more and see if that helps further.