AM-101 Clinical Trial — Participants Updates and Discussion

@bedouin Can you compare your first set of injections with this round? Maybe with the parameters of:

Pain, fullness, effect on tinnitus (both loudness and annoyance)? If you remember, I'd love to see a comparison on a day by day basis from post injection day 1 (which would be the day after the third injection) through post injection day 14.

Hope you are doing well and made it home safely.

 

Thanks OddV. Yup. Home safely after a long 3 day hospital stint. Day 3 was another "sweaty palm" session. I did load up on ibuprofen, paracetamol and codeine beforehand. So this time round, injections were definitely less painful. Plus, the ENT injected into the bottom part of the eardrum. First time, he did it on the top. He said that could well be the reason this time was less painful.

You'd think an ENT would know that and do that the first time round. However, i also understand and everyone is different. Maybe most people don't feel pain when injected at the top of the eardrum. So maybe a combination of needle location and pain drugs, made the experience overall less painful. However, i was still very nervous, i think anticipating the worst. Last time i screamed. According to the trail co-coordinator AM reported only 1 out of 8 expereinced pain with the injections. The fact that both you and i found it uncomfortable makes me wonder...

So this is day 4. Ears very full and blocked. A good 3 hour journey home. I can hear myself talk which is really distressing. T is very loud in both ears. Like a 9 or even a 10. I think because the ears are blocked, the t seems worse. Any sort of external input, masks t. So if your ears are blocked (feeling deaf), then you are not getting as much external signal into the ear and thus your t has a party and sounds louder. The t is really cranked up today.

However, I also had to deal with a crisis on day 2 (when it rains it pours), 3 and 4 (and ongoing) unrelated to t, so i think that has possibly put my t firmly in the red. If this works, the people that have caused me distress whilst on this trial will be brought to bear and my judgement shall be swift. I sound like Judge Dread. Lol. Seriously though... last thing i needed.

After day 1, 2 and 3 injections, at night, the fluid gel seeped out of the hole in the eardum (esp the left). I asked the ENT about that and if it made the treatment any less effective and he said No. The 30 mins that you lie still, head to one side on pillow, is the window of time that the drug needs to work (presumably). It doesn't make sense to me but ok. Seemingly the drug when injected into the middle ear (and there is a lot if it (fluid) according to the ENT), seeps across the oval window membrane into the cochlear. That is why i was told not to talk. I also did not swallow for each 30 minute silence. The ENT thought that was a bit excessive but i remember reading that the Eustachian tube empties upon swallowing which would allow to drug to go down my throat. So as uncomfortable as it was, i made sure, not to swallow.

Feeling pretty miserable about it all. I guessed i would see an improvement by now after the real drug. According to the phase 2 paper, ppl started seeing an improvement after day 2. Even if the ears are blocked, the t should start coming down on day 3, if the drug works. I will obviously give it more time as the paper also says max improvement is at day 90. The one thing that is worrying though is the bar chart on the phase 2 report shows a "much worse" in the high dose and not in the low dose or placebo. I think I am just panicking here because my t seems excessively loud. It was loud last time after the injections. Maybe this time, i just expected it not to be this loud. I'll let the eardrums settle and then monitor.

How is your T now?

To answer your question, yes, it is pretty much the same as last time. The same fullness in the ears (deafness) and blaring T. So at this point no way of knowing if real drug has worked, placebo first time. No change. I don't want to blow my nose to unblock my ears as ENT says can affect the healing process of the eardrum perforation. So i'm just going to sit it out and try and mask. Loudest sounds on now....don't even mask my t :-(

Anyone else on here that had improvement at 3 days after having the real drug?

I asked the ENT when he thought i should start seeing an improvement. He didn't know.

~bdn

 

I'll post my day 3 summary when I get home... But I don't see how anyone could report an improvement after day 2 based on the fullness and your ear being entirely thrown off by this experience, just my opinion.

I'm giving it until Wednesday before guessing what I got ☺

 

Day 3 Injections Report (November 7, 2014)
I was miserable last night, mostly due to the full feeling in my head. It was so bad, I actually forgot about the T for a while (silver lining!). Took Tylenol twice yesterday... Less fluctuating of the T... Loudness is about the same, however, I'm tuning into the T way too much (somewhat obsessively), so I don't think I can accurately report any changes right now.

Every time I yawn, cough or sneeze, I have a quick pain in my ear that rapidly goes away. I did wake up with the T this morning.

No audio test today since I didn't report any changes in my hearing like yesterday... I only had the balance test today.

The injection today pain wise was 3/10. Most full feeling I've had yet, T spiked to an 8 right after the injection (down now). Quick vertigo again (they hand warm it now, they think injecting it cold caused the vertigo in the last phase) that subsided after 3 minutes. I was able to drive home with no issues. Inside of my ear is itching a bit.

Would I do it again, yes. Will I move on to the next phase if I don't get relief? Yes. I can't stress enough, if you do this, take someone with you.

I'll post my loudness and annoyance tracker at day 10, 30 and 90.

 

@bedouin

Just a quick question please.
How long did it take for your T to go back down to normal after the last set of injections? A week or more or a few days? Thanks
How many months in to your T were you when you had the first set of injections?
Was it in August when you had your first set of injections and did they tell you yet if it was placebo or not in the first set? Would that then mean that you were already 9 months into T before you had your first set of injections placebo or not?
You are due your next set (2nd set of real stuff) in December and then finally third set of real drug in February or March I think you said (from memory which could be wrong)? Just to confirm the timetable please. Thanks
By the way, please could you let us know as soon as you begin to feel improvement? which I sincerely hope you do!!
Thanks for posting such a detailed report and hope you are feeling better..

 

@OddV

What @bedouin is talking about re the improvement after 2 days post injections is this

The improvement in tinnitus was gradual over the 90-day observation period (Fig. 3). In the first days, tinnitus loudness increased slightly as the eardrum was still open and sound perception may have been temporarily altered. TLQ started to improve in the high-dose group on Day 2, before the third injection, breaking away from the 2 other groups. At Day 90, the mean tinnitus loudness in the high-dose group was 43.2% lower than at baseline (49.5% for unilateral cases). This compares with an improvement of 17.7% (10.0%) for the placebo group.

Of course I am sure that you know this and that this post is utterly redundant but thought it worth clarifying what he was saying in his post. Just maybe makes it clearer for readers to understand his post in case they have not read the clinical outcome of phase 2.

 

It's difficult to say exactly. Last time, by mistake, i held my nose and popped my ears to get rid of the blocked deaf feeling. The ENT said i should not have done that because it delays the healing process of the hole in the eardrum. By blowing it, you are effectively, opening the hole again. So last time, I was not this blocked for this long and I would say it took a few days to be able to hear again. Then abut a week or two to get back to normal. This time they are very blocked and feel deaf. I'm hoping that it will just subside with no interference by blowing down hard on my ears with nose blocked to un-pop them.

9 months - (check the earlier post - i'm pretty sure i did say that)

Yes (i'm pretty sure i explained all this in the previous post)

They don't tell you if you get the placebo or not. Not then, not now and to my knowledge, not ever.

Correct. Phase 3 takes ppl 3 < t < 12 months.

No my 2nd set was this week - real drug (said that too already in prev post - sorry it was confusing)
3rd set if i want them - Feb
4th set if i want them - May

I will for sure

Thanks. I will post if i see an improvement. My T, btw, was from acoustic trauma. Exposed to loud music for too long.

 

@amandine thanks, in reading the clinical paper, it wasn't clear to me if it was day 2 of the injections or day 2 after the 3rd injection.

They ask you to rate the loudness over the last 24 hours, I don't see how anyone would experience a decrease after having your middle ear assaulted in the manner it is during this procedure. Also, having an audio test also (IMO) makes the perception on the T louder. In my case, I have a suspicion on what I received, but I'm not going to make any public guesses until Wednesday, which is a week from my 1st injection.

Head is very full this morning, T fluctuating.. Did wake up with it... Last report until the 17th,which is when I go in for my 10 day.

 

@OddV

T fluctuating sounds good - hopefully it means that something is happening and it is going to start to improve post injections.
From what I have read so far, when you have the fullness continue for a while, seems that this is post real med and not placebo.
I could very well be utterly wrong but seems that when it is placebo, the afer effects of fullness etc... go away much more quickly than when receiving the real deal....just from reading other people posts do i get this idea.....
Hey what do i know? Nothing of course...but look at @bedouin post above as well and he seems to be experiencing longer side effects and we know for sure that he received the real deal this time....

 

@amandine how long does the fullness seem to continue if you receive the real deal?

Having a tough time with the fluctuating T... It's not something that is immediately noticeable, but all of a sudden, I realize that it's a different volume.

@bedouin @NewGuy can you describe what it means when you say your T is fluctuating

@amandine are you still trying to get in the trials?

 

@OddV

Re fluctuating and duration - that is a great question. I think the best thing to do is to put out a question / thread / poll or whatever to ask people who have had these injections exactly this question. I am only going on memory of what I have read from other people posts. Says noting on the AM phase 2 trials info.

Yes I am. I have been following the threads and looking at the trial date from AM phase 2 and it does look like its worth doing.
I found on my phone that Toulouse where it is being held also did phone me - but they left no message. They called me on Thursday and I found their number on my phone yesterday.
So i am calling them on Monday after weekend.
But I must admit that I am seriously scared of the thought of injections into my ear.
However for the first time I will be able to speak to someone at the trial centre.
Bugs me tho, that in usa and UK they are giving fuel and hotel expenses. These are recompensed to hospital by AM.
So why did I receive an email saying that only fuel reimbursed in France? It is not the hospital that pays, it is AM. So I need to have a hotel as well or do the people in france sleep on the street whereas in UK and USA they sleep in a hotel.
I am going to speak to the trial coordinator on Monday and explain that I am very far away and will need hotel and see if I can sort out that.

Please OddV could you explain what you mean by fluctuating? Is it going up a lot and then down? qute often in the day or every hour? What do you mean when you say that the tone is changing? Is it going up or down or more bass like or what? Or is there a hiss or lack of hiss? Please could you explain what you are feeling a bit more please?
Then it may be easier for @NewGuy and @bedouin to exaplain what they are experiencing?
Perhaps a poll or thread as suggested above to see clearly the different aspects - ie fluctations up down, tone changing, fullness in ear, length of time for eardrum to heal, T up or down for how long, etc....and any thing else u can think of.
Just seems to me that when we have these specific polls, it makes it much easier to see what is going on with how many people.
I cannot set up a poll cos I dont know how to do it and anyhow i have not yet participated in the trials. Really it needs someone who has taken part to do this.
Thanks for getting back to me so promptly

 

Hi @OddV and anybody else here. When you rate your own T on a scale of 1 to 10, can you describe what that means? I'll give an example of mine--usually when I wake up in the morning with no sound masking, I gradually become aware of the T, but it is very light and benign, which I would rate at 2/10 or 3/10. Then if I am busy throughout the day at work and I am in a really quiet environment (my office is very quiet), and I start focusing on it, it's probably 6/7 out of 10. But I have read about others who describe theirs more like a jet engine, etc., which sounds like it is a lot louder than anything I am experiencing. Another example, right now I am sitting in my living room with the TV, dishwasher and my son making noises, and when I specifically try to listen for it, it is like a 2/3 out of 10 again--not too noticeable.

Still going back and forth on moving forward with the study--I am more motivated by the potential benefit than by helping the study to be honest. I'll be interested to see what all your reactions are first, although this is obviously a small sample size.

 

One other thing is I'm interested in all of your hearing before and after. I have sound induced hearing loss in the left ear (also where the T is) but honestly I don't even perceive the hearing loss there. It wasn't until the T that I even knew it was there. I did have some after my infection for a few weeks where it felt full and like a wall of sound in big crowds like you described but that part of it definitely subsided.

 

It's so subjective, I've tried to fix a scale in my mind. 0 is no T, 10 is life threatening T and I've got it setup in my head kind of exponentially (like the Richter Scale).

I typically wake up with a 6, throughout the morning and into the afternoon, it goes down as I get busy and focus on other things.

Usually when I get home, it ramps back up... I rate it a 7 if it's "rattling my brain" or I can't watch TV for more than 30 minutes. An 8 for me is a panic/anxiety attack due to the volume... I had 2 of those early on... I've never reached a 9 on my own scale.

Right after the 1st and 3rd injections... I briefly had an 8, but it quickly subsided and I didn't have an attack.

I've got minor hearing loss around 8k, I "think" my T is around 9800 kHz. I haven't been tested this high. I used the AudioNotch website to try and determine.

My T is a hiss or a whine, kind of like a tea kettle.

 

@OddV

Please may I be rude enough to ask you your age.
Apparently its quite normal to have a little hearing loss around 8KHz after a certain age which i think begins at 40.

It is I think practically impossible to judge the kHz of the tone we have in our head or ear and the hearing tests dont go higher than 8. How did you do yours on audionotch? Did you play the sound till it drowned out your T? If so at what volume? Cos if the volume is lower it wont drown it out and if the volume is higher it may - so i cant see how to do this test at all. Please if you have any ideas as to how to do the test then please tell me.

When you went for the trials, they did hearing test on you and also tested your tone of T. Did they not tell you how much approximately is your T tone? Or dont they do that?

I have the same but i am in my fifties - apparently a bit of a loss around 8khz but apparently normal in my fifties.
Mine is also exactly like a tea kettle which incidentally is the only sound that completely and immediately masks it

When you are focusing on other things, therefore taking your mind away from the T, it should go down?
My problem is that I am obsessed by it all day which I think makes it worse in my head

Just as an aside I had a blood test today to see if there is anything going on like lack of something such as b12 or whatever. Results on wednesday next.

Did you have a think about doing those polls or questionnaires re the effects during and after the injections?

 

@amandine not rude at all, I'm 41.

Not sure what volume I used, it was probably about "mid"... I ramped up the tone until my T disappeared. It happened around 6,800 kHz early on and again around 9,800 kHz.... I will say it aggravated my T something fierce after I quit doing it.

They did not test my T tone, only the minimum masking level (forgot to ask what it was, I'll ask when I go back).

A shower or standing in front of a sink with running water immediately makes it go away for me... Haven't tried a tea kettle, I will though.

Not sure on when I'm not focused on it, it just seems to fade away... I'm assuming this is what people describe when they habituate... If I search for it, it's there.

Not sure if setting up a poll would help... There are very few of us going through this right now and the ones that went before us seem to have disappeared.

I know your situation as you and I joined around the same time... Please try and find someone to go with you. The process overall isn't unbearable, but there is some anxiety involved and having someone with you that you know does help.

 

@amandine I'm sorry to hear that your T has caused you a lot of anxiety. I know exactly how you feel--when I first started experiencing it I felt a really heavy level of anxiety. When I realized that it was affecting my daily life, I called a counselor to talk about it a little bit. I find that talking is extremely helpful and to express how I was feeling to somebody listening validated my thoughts and made me feel less scared and anxious. And knowing that T is very rarely indicative of anything more serious is also comforting. I actually found that talking to people about it and expressing fears and anxiety has helped me feel a lot less anxious about it. The last couple weeks it has even allowed me to go to sleep without any masking sounds--in fact, knowing that the sound is there kind of helps lull me into sleep. The human brain is able to adapt to things much more than we give it credit for a lot of times--and doing things like talking actually does "re-wire" things in a beneficial way. A counselor told me that something like this is considered an adjustment--and an adjustment can take up to 6 months to just get used to. But knowing that people do adjust and move on is really good to remember.

Hang in there!

 

@OddV

Yes same for me - a tap running or a shower and it disappears or electonic toothbrush. I have the old fashioned type of kettle - big shiny thing that sits on the wood burner all day ready for a cuppa or on the gas stove. I know the sound is practically the same as mine when it is just before boiling, say a couple of minutes before boiling.

Also this is one of the reasons that i did not want to test too much for the tone that i have cos i felt that it would not be good for the brain and may cause some kind of shock - as you experienced.

Have you had a look back and seen that the ones who have done this have definitely disappeared?
Would it be possible to take a look and make a list of those names who participated?
I shall send out a message privately to each one asking them if they can report on how they are please etc...
Cos they will probablly get notification to their email that there is a message waiting if they chose that option. They could just be lurking.
Yes or they could be gone forever which means that it works!! so that is good news for you and a good reason for me to go and do it too.
it is the fear and the logistics that have prevented me.
Alternatively I could try to get back to UK, sign on with a GP quickly and get onto the trials in UK - where I prefer to be anyway. And I know that they will pay my expenses. I am torn about doing it in france cos I dont want to be here another year and it could take that long re the 2nd 3rd and 4th set of injections. I personally think that if it works, it iis a good idea to get more of the med each time every 3 months to reinforce it. Here i have to travel 300kms each way and with no funding for a hotel I may have to stay in a camper van in the winter next to the mountains which is Toulouse. Not great eh!!
So that is why I am still sitting on the fence. That and the fact that it is well documented that it goes away often up to one year since onset - maybe the ears just need time to calm down. I dont know.

But think it a good idea for us and for Bedouin and others on this trial and for the forum in general, if we can try to make contact with the disappeared and see how things have progressed. This in turn will help with my decision making and others who like me are stil sitting on the fence about this. There are many more months of this trial left and it may encourage others to take the plunge - especially if can see that it is helping.
anyhow i hope you are having a nice saturday
and yes i do agree with you
once i am free of this i will probably not frequent this forum that much - however i do feel that i should do something to bring this into more puvlic focus and much more work and funding needs to be attracted to this invisible illness which can kill people slowly.

 

@marqualler

Hmm well thank you for your kind thoughts. However there is no such thing as a counsellor here in rural france. No i am left to deal with it alone and with no meds cos i dont trust the medication to not do more damage.

 

I never said my T was fluctuating. My t is very loud after the injections.
After injection day 1 - 8/10
After injection day 2 - 9/10
After injection day 3 - 10/10
day 4 - 9/10
will report day 5 tomm

I don't think you can make that conclusion. I said above i popped my ears during the placebo run and that is possibly why the perceived loudness is higher this time (i have not popped them). Think of this. Stick your fingers in your ears and your t seems louder right? That is the same thing having gel stuffed into your ears. The blocked feeling makes your t "sound" louder just because you have no crisp external stimulus to mask it. In fact i thought t must be absolute hell for deaf people. All you have is this hum.

I would insist on it. Have a look at the posts from the other guys. This is not a fun day out. You are normally away from home, without support. The very name clinical research should tell you. You are a number. Yes, the ENT and the trial co-ordinator are all very professional but it is you that has to deal. I have found that t has reduced my capacity to deal with every day things like i used to so i found it prob tougher than most. Last thing you need, is for you to have t0 pay for that anxious experience. So insist they cover all your costs. They have lots of money. The trial co-coordinator confirmed it.

I think you are getting confused who is asking the question. Look at the post. It is OddV asking me and NewGuy "can you describe what it means when you say your T is fluctuating?". It's not him saying he has fluctuating t. I responded to OddV above already saying I never said my T was fluctuating. See top of this post.

It might be useful but very few of us doing it at the mo. Look at the stats only 7 or 8 have answered the question if t is higher or lower after injections. Others have left the forum or onto a new thread.

I wouldn't feel bad about that. Most of us are here to help ourselves first. Just a note for you marqualler, a t of 3/10 is manageable. My t used to be this. If you can find a way to keep it at that, i would not go the am101 route to be honest.

Again - no reason to mess with something if it's not "that" broken. But your call.

 

Yeah, 3/10 would be manageable in my opinion, guess I would be worried though if it got worse down the road and I could have taken care of it now... Very tough call... I guess I'm glad mine was loud enough that I didn't have to factor that into my decision ☺(got to keep looking for those silver linings).

 

@bedouin

Thanks for such a well thought out and composed reply.

Please may I just say that it is OddV who said that his T is fluctuating.
Here is the quote

and

He mentions fluctuating T quite a lot and the first quote is the latest after his injections.
Hope this clarifies why I was asking about fluctuating and @OddV.

i have this awful sound in my head and for a moment there I thought that I had lost the plot completely!! LOL...But thankfully you made me go back and make sure that no I am still a rational thinking person with a good memory.....at least that eh!!

 

@bedouin

Forgot to add that @OddV also says that his tone is changing too,,,

 

@bedouin

and yes you are right - I am going to insist on the expenses being paid to me. They have lots of money coming from Auris Medical. Trouble is that if i insist on it, they can just say oh we are full up or no we dont want you cos french is not your mother tongue, which is what incidentally happend with Tours study centre which is a lot closer to me than Toulouse. The stupid doctor at Tours assumed that i dont speak french and suggested that i find an english speaking study in France...how ridiculous.....and when i sent him a full and long email in french he simply ignored it....
If i had just gone to Tours with no questions, then i no doubt could have participated in the trials there. But due to personal financial restraints, I need to establish that my expenses will be paid by the hospital. They then claim it back from AM...so I find myself in a catch 22 situation in france.
This is why i was so pleased when the trial ooordinator from Toulouse called me back even tho sadly i missed her call.
I have also been told by someone who knows her that this trial coordinator in Toulouse is a very kind and caring and compassionate lady and was recommended to speak with her. So this is the saga in france re the trials.
The docs on these trials do seem to act without much compassion. I know of another person who was summarily kicked off the trials with out a really good reason and no opportunity to speak up and say something. Nor were this persons expenses completely covered once kicked off even tho the trial doctor insisted that this person make a special and very lomg trip back to the hospital to return the electronic diary. The info that the trial had ended for this person was made by phone the evening prior to setting off for the injections....even tho the hotel was booked and paid for...for which there was no reimbursement even tho promised nor expenses covered completely to return their electronic diary. This did not happen in france by the way...

 

Yeah, I should probably clarify... The loudness of my T is going up and down... The more I listen to it, I don't think the tone has changed. However, the loudness fluctuating isn't immediately noticeable. One minute, it'll be a 7, then I'll notice an hour our so later that it's a 5, or something else. Not the same as tuning it out. Trying really hard not to pay attention to it right now, but with the fullness, and as Bedouin said, it's like a party in your head.

And, with that, I'm signing off the forums for a while... Will come back in a few days.

 

It was that the question came from OddV asking us about fluctuating t. Then your response was asking him about his fluctuating t. SO i didn't follow. If you were referencing from a previous snippet then ok, my apologies.

re the trial centers - yes, it seems very cold when suffering people get treat like that.

 

So, interesting thing to report. I've got a weird "electrical" noise going on... It's a similar jarring sound that I had during the first week after onset... If I listen closely to my T though, it's seems softer this morning, but the "electrical" sensation is riding on top of it making the overall noise in my head seem louder. I don't think I'm doing a good job of describing it, but it's the best I can do.

Still have the full feeling, but it's not as bad this morning... Woke up with T as normal.

Also, just remembered, after the 1st injection and before the 2nd... My T moved briefly to the center of my head and into my right ear (only lasted about a minute), this had not happened before.

Don't know what to make of it, but thought I'd report... I'm keeping a daily journal and will post that in full after my 10 day checkup along with a graph of my T loudness and annoyance.

 

@OddV

Thanks for keeping up with the reports. Really helps to know what is going on with you (and others) to see how and what this drug is doing.
Maybe the feeling and the electrical stuff going on is the drug acting on the nerves firing off. Maybe the nerves firing are having one last party before they calm down and wave good bye so you get complete remission from your T forever. Totally non scientific of course LOL.....
This is your first set of injections but sounds like you did not get the placebo cos stuff is happening to your T.
wishing you well

 

I was just wondering how everyone is able to gauge at what level there T is every day after the drug was injected. Do you all have what I call a straight tone sound that never changes other then volume? The reason I ask is mine is always all over the place with all different sounds. Tones, hissing, electric sounds, pulsating, etc.

 

@beemovie I've got constant tone, but with the injections and audio tests, it aggravated it... I actually remember telling the doctor that he had pissed off my T.

That's actually one thing I didn't understand after reading the clinical paper.... How anyone could report lower T after the second injection after having your ear assaulted. They ask you "over the last 24 hours"... Not sure about @NewGuy and @bedouin and if they have single tone. I think I had mentioned before that I've set up my own parameters in regards to how loud I perceive it.

I'm doing myself a disservice right now because I'm constantly monitoring it, looking forward to getting back to work tomorrow so I have other things to focus on.