AM-101 Clinical Trial — Participants Updates and Discussion

So yesterday was day 1 of injections (2nd set - real drug) of AMPACT2. Because I knew how painful it was going to be (from last time), i was pretty stressed. By 4pm i was sweating and seriously thinking of pulling out. However, having made such a commitment, i decided to go through with it, chanting the mantra "pain is transitory". First the tinnitus match with the audiologist, hearing test, eye check for stigmatism or irregular pulsing eye movements, bloods taken, weight, pulse, blood pressure, urine test, sign consent for AMPACT2 and off to the injection room. They first put in emula cream as a local anesthetic - thick syringed onto the eardrums. Cold cream touching the eardrum makes me wince.

Leave on eardrums for 30 mins. Makes you feel very dizzy but temporary. Then the suction off the right ear (very noisy and sometimes painful when the suction gets a hold of your eardrum or touches it - makes you feel very dizzy but temporary.) and syringe am101 into the middle ear. Didn't feel a thing. Relief! Phew! Wait 30 mins without talking or swallowing. Suction off cream left side (a bit more painful because my left ear always is) and inject. This time a bit of pain when the liquid is "pushed" into the middle ear. Done. Phew! Now just wait 30 mins, no swallowing or talking. All the while I am thinking "this is the real drug" and "I have to make sure enough of the drug seeps into my inner ear". Keep still.

So quite an ordeal. Left ear already starting to hurt with pain from the syringe. I'd taken pain killers (with codeine) the night before for general pain. Comes up in the urine test as opiates. It was nearly touch and go if i got the drug.... but i make it through.

Here is the amazing thing, even if it only lasted for 20 minutes. Last injection was at 4.30pm. My t that day had been low. What a great day when we have those right? About 6.20pm to 6.40pm - my t just disappeared! It was like i had my old life back. Almost silence. I say almost because there was still a very low t in my left ear. The lowest it has been in 12 months. I almost wept with joy! However, it started ramping up again :-(

Ears were blocked that night. TV to take my mind off things - but hearing muffled. Couldn't really sleep with ear pain. Woke in the middle of the night with what felt like my left ear clicking... As if pressure from inside was letting out trapped air. I let it just happen. T at this point was very loud in both ears.

T this morning loud (8/10) but now maybe down to a 6 or 7. Go back today at 12 noon for 2nd set of injections. Loading up on pain killers, as day 2 and 3 always worse than day 1, as ear is inflamed and they go through the same hole. Feeling nervous but going to continue to Thursday. At least I can say i had the real drug.

Whether it works long term - time will tell. That 20 mins of silence was golden. I'm hoping that it was a reaction to am101. But maybe the brain t kicked back in?? Maybe 2 more injections will bring it down. Here's hoping.

 

@bedouin

Thank you for posting such a thorough report and please keep positng.
Quck question, when you go for the trials, is it just a one day initial interview. After that, if you are accepted in to the trial, it it something like a fortnight later and then you go for another appointment where you get the diary?
And then a fortnight later you go for you above appointment with blood tests?
Or do you go for first appointment, then get assessed and go back for next about 2 weeks later where you get blood tests and the diary etc...and then 2 weeks later you for injections and more blood tests?
Please could you write a brief summary of the list of appointments and the times between each appointment.
Would really appreciate it.
Thanks
@NewGuy seems to have disappeared!! It has been over a week since he last posted and he said that he would keep us posted and updated so now getting quite cncerned if he is ok or not. He had his injections and then he had his first follow up appt last thursday 30th October but since then nothing. Anyone know anything about New Guy and if ok....worried....

 

Hey amandine,

Initial interview: 1 day - they give you the cellphone plus do loads of tests and you have to make sure you complete it every night (at least 80% of the time otherwise DQ).
+-14 days later - more tests in the morning.
You hear that same day if you made it through the morning tests. It seems crazy to me because essentially you could fail at this point!
If you get through, you are enrolled into TACTT3 an drugs are dispensed from pharmacy.
That same day, that afternoon, you have injection 1 (call it injection day 1). If t in both ears, then injection 1 (left ear) and injection 2 (right ear).
Next day - (call it injection day 2) - get 2nd injections (either 1 if t in one ear only or both if t in both ears)
Day after that (call it injection day 3) - get 3rd injections
Set the "day" clock to zero.
Return at day 10 for checkup
Return at day 30 for checkup
Return at day 84 for checkup

End of TACTT3

On day 84 you come back for more tests and if you want to then get the real drug -> Sign consent and get enrolled onto AMPACT2.
Same process all over again except i was told today you don't need to do the cellphone questionnaire every night. That was my detailed explanation above.

All:

Today: 2nd injection day of real drug. Quick eye shift test. ENT checks ears. Hole still in eardrum so can't use anesthetic. Panic. ENT has to get needle through the old hole. Right ear was ok-ish. Left ear (a sharp spike in pain when needle hits eardrum) - a little bit more when liquid goes in but it's over quick.

Ears still blocked. t up on both sides. Tomm is last day of injections. Will keep you all posted if any shift in t. I used lots of pain killers (codeine and ibprofen) + paracetamol to counteract any pain. Off the blood tests now and codeine ok to use. I think that helped a lot with the pain. Last time was much worse. Hopefully tomm will be as painless and it will be over.

 

When I was all congested last month with lots of mucus my hearing was muffled. The ringing went down. After I got better it came back to as it was. I wonder if if it was just the fluid (the drug) that was put in your ear that made it go down.

 

@beemovie

What else could it be?? Maybe it was the anaestheitic. Cos the drug cant work that quickly. Or what else could be the reasonn. Please elaborate...

 

@bedouin

thank you for such a detailed repsponse to my query. Much appreciated.
How is it now for you on day 2?
how is the t?
did they tell you at the centre that there is no chance whatsoever of making things worse? Cos fm what i understood, they said before that if someone had T in both ears that they were only injecting one ear 'just in case' but you have had both ears done. Or did I get that wrong?

Please keep us posted.

So you are now nearly one year since t started and yet they are still prepared to give you the drug. This means that they firmly believe that it works past 3 months and certainly up to 12 months. Otherwise they would not put you at more risk unless they thought that it was going to work and be beneficial. Otherwise, if they dont think that it will work on post 3 month people, this then would not be good for their results page would it as they are also giving places to loads of people who have had T for more than 3 months and up to 12 months - as far as i can read, most of the participants involved in these trials are over 3 months. not under 3 months, up to 12 months. So i think that in phase 2 they proved sort of that a reduction was possible in under 3 months of T and now they are wanting to prove that it is ok after 3 months - hence the 3 separate trials after thei initial one...but one thing that gets me is that they never said that they can get rid of it - they only said that they can possibly reduce it......

I sincerely hope you are feeling ok

Is the trial centre far from where you live? Did you have a long journey to get there and staying in a hotel or are you close to home? Just wondering cos obviously it is less stressful closer to home. Anyhow, please keep me / us posted on how you progress....thank you again for all the info

 

Yes. T in both ears then get injection in each.

No i wouldn't say that. They did trials < 3 months and results were ok. Now they want to see if they get people in the 3 to 12 month range get a reduction in t after am101.

It's a bus and train ride away. About a 1 - 2 hr journey. Staying in a bnb.

No

As said above: Ears still blocked. t up on both sides.

 

@bedouin

thanking you again

as an aside i am quite concerned for NewGuy cos he has not come back to us
Did they tell you that you cannot post on forums at all? at the trial centre? Obviously not so that would not be the reason that he is not posiing.....
By the way, I think that you are very brave
I have now found the direct contact for the trial study coordinator for me at Toulouse and can ring her to ask about doing the trial but i am very very afraid.
Did you find that the T made you irritable at all and has it had an effect on you so you take it out on the people around you. I am so irritable with it and so nervous and I dont know what to do with myself. I am just so full of fear and sit alone in my room all day.....
and cannot slleep more than 3 hours or 4 max.
Last 2 days it was really low but when i woke again after 3 hours sleep I took a half a xanax to get more sleep but when i woke up it was blaring. Dont know what to do?
I read that the am 101 is only for reducing and not for eradicaton of T.
But that aurifony are using the same drug as trobalt or retigabine but withoiut side effects.
So are you aware that it will not get rid of the T this am 101? Or did they tell you at the study centre that it can get rid of it? What am i missing if it cannot get rid of it? Confused and would really appreciate your thoughts on this....cos i feel so alone here with it.
I think that you are very very brave!!

 

I hope to god that this drug helps people. But please keep in mind that this company went IPO in August. They used the hope of this drug in their stock offering as the pitch to sell stock for the IPO.

 

The phase 2 paper looked promising... You'd have to think that the data was faked if it's just an IPO ploy.

 

I never said any data was faked. They had a established proof of concept which is all they need.

 

Didn't mean to imply that at all, just what had popped in my mind.

 

Dont mind me anyway. My wife and daughter went to NYC to see the Lion King. I wont go, am too worried it will be too loud even if I wear ear plugs.

 

I tried to get on this trial a few months ago,spoke to one of the guys arranging it who told me it had an 80 per cent success rate

 

I guess none of the 80% are on this web-board.

 

Dude, go with your family. You can get 32db earplugs for $2 (Howard Leight Laser Lite). I'd wear them and some over ear ear defenders (covered by a beanie hat if I cared enough) if I had a family outing. The thing is enough of a visual spectacle that with 50db of protection and your arm around your family, you'll have a good time.

 

You would think that would work. But even if I did that , I would have to walk a mile or so once in the city, but almost any activity such as walking gets the ringing louder and louder and pulsating, then if I put the earplugs in it will even seem louder and sometimes takes hours to calm down. They wanted me to go but I said to please take my mother inlaw instead. But thank you very much for the beanie hat idea. I never thought of that. I dont own one but I am buying one.

 

Tinnitus Onset: September 22, 2014
Cause of Timnitus: Middle ear infection (Otitis Media)
Loudness of Tinnitus (scale of 1-10; subjective): at onset - 7/8; at time of injections - 6/7
Annoyance of Tinnitus (scale of 1-10; subjective): at onset - 8/9; at time of injections - 6/7
Pain of injection: 2 out of 10 (getting a shot for a dental filling is worse)

My experience is similar to @bedouin.

Day 1 Injections Report (November 5, 2014)
Started at 9 AM Central Time today (3 PM UTC). Did a normal hearing exam including bone conduction and then did a minimum masking level test. Once that was complete, we did a balance test that included a goggle contraption that tracked my eyes as I followed a red light. This whole process took 1 hour 15 minutes.

I then had to answer more questions and had to take a drug test. At this point, I was allowed to go to lunch and was told to be back at 12:45 PM (6:45 PM UTC). I then had to answer a series of questions in my electronic diary that I had not seen before.

The doctor then came in and checked to make sure I didn't have any infection in my ear. Once he confirmed that I did not, I was told that I had been accepted and would be receiving the injection.

They squirted a numbing cream in my ear and let it set for 30 minutes. The clinical nurse went to retrieve the trial kit from the hospital pharmacy. The numbing cream was slightly cold and made it feel as if the left side of my head was underwater. After she returned, they suctioned out the cream (in my opinion, this was the WORST part of the whole procedure) and gave me the injection. The entire injection process lasted about 2 minutes. As other have described, my ear felt very full and my Tinnitus volume went up. I'd describe it as an 8. I had to lay with my head to the side (the clinical nurse stayed with me the entire time, I was the first at this site, and we chatted about a variety of items). I was asked to not swallow, cough, sneeze, or move during this time.

After the 30 minutes had passed, they set me up and asked me to sit still for about 5 minutes. I did feel dizzy for about 2 minutes, but it quickly went away. They then asked me to get up and walk around; at that point, I was allowed to leave.

The fullness feeling has somewhat gone away already. I have slight pain in my ear, but it isn't too bad... I'll probably take some Tylenol before bed.

Since the injection, my tinnitus has been all over the place. It has gone as low as a 4 and as high as an 8. Right now, it's a 7, which is what it was when I went in this morning.

I'll report in tomorrow after day 2.

 

Sorry to be gone from the forum so long. My follow up visit went well. They cleaned my ear out , it had a bunch of nasty filth in it. They said the hole was closed up. I Have not had any fluid drain out since they cleaned it out. I still have a "full" sound to my hearing, if I hold my nose and blow pressure to my ear I can hear normally. I am hoping this becomes more permanent. As I type this my T is a 8/10. There are times during the day that I can't hear it at all and others when it is loud. I am scheduled to go back next Friday for a second follow up visit. I have just been going about my day doing my best to ignore it and it has been going ok. @amandine and to all others I am sorry I have been absent for the last week, just been busy with my kids, I will do my best to stay more up to date. Also all the earache pain is gone. I am still alive and kicking, ha ha.

 

Also, I hope everyone had a great Halloween!

 

No

Thanks. Sometimes i wonder if its bravery or stupidity!!

Yes. The days during injections - ears are clogged so quite irritable. Deaf-like. I try to remain calm but it is a challenge. All depends on personal circumstance tho. I am feeling very unsettled at the mo in general so i think i'm having a tough time of this. Partner is very supportive but it has been a struggle. However, might all be worth it, if it works....

No. Me neither. When it is like that staring a day blaring - most days i just try and mask it out with sounds from the pc - ocean waves - esp if working on pc.

I doubt am101 will get rid of it. That is obviously what they and we hope for. But the results weren't glowing in phase 2. I would be happy to just get it off this 7, 8 or 9 / 10, down to a 4 or 5 / 10 so that i could cope with life. So even a reduction for me would be worth it. They don't tell u at the study centre that they can get rid of it. Nobody knows if it will work at all. That is why it is a trial. It's a maybe.

Sorry to hear you are having such a tough time. I hope today is better for you!

 

Hi all,

First time poster here. I am 31 years old, married and have one son. I started feeling tinnitus in my left ear about five weeks ago--at first I didn't think much of it but after a couple days I went to my GP who prescribed antibiotics for a double ear infection. (I got the ear infection I'm pretty sure from the bad cold that I got from my one year old son who just started at daycare--wash your hands, everybody!!!) Anyway, the doctors at that time told me the tinnitus would clear up with the ear infection, but it did not. I started seeing an ENT who gave me an audiogram which found that I also had some noise related hearing loss. I have played in a band for a few years and while we only practice on a weekly or bi-weekly basis, being a drummer certainly couldn't help.

Anyway, fast forward to today--I would say that my tinnitus is better than it was when it first started--when it first started I was honestly quite depressed and anxious and would rate the sound at about 7/8 out of 10. Since I have gained some perspective on it, I would rate it more around a 3/4 out of 10. Additionally I used masking sound to go to sleep for the first couple weeks of it, but found that I was still waking up about every two hours. (Probably half the noise, half the anxiety.) Since then I have not used any masking and have slept much better--last night only waking up once to go to the bathroom.

I talked to a researcher about the AM-101 trial taking place closest to me in Iowa, but after meeting with my ENT today, he recommended that I have a tympanoplasty because he found that my ear drum is still inflamed (Myringitis is what that is called). He said I could take part in the AM-101 trial if I was motivated but that it's possible that the Myringitis would disqualify me from the study. To be honest, I'm hesitent to do the study based on what the results have been here so far--I don't want to do anything that would make my hearing or tinnitus worse, and if what it sounds like that the actual results have not been impressive yet--that kind of answers the question for me. I'm hesitent to do anything that doesn't help and that also takes me away from my family for days at a time.

I guess that's all I have to add here--I'm monitoring this to see if anybody has any positive experiences and hoping and praying that the tympanoplasty will help the tinnitus and hearing a little bit. Thanks all for listening!

 

Hi @marqualler welcome to the board. Your onset and experience with T is similar to mine, albeit I would describe mine as a bit louder than yours.

I made the decision to participate based on numerous accounts I've read plus reading this paper... http://journals.lww.com/otology-neu...afety_of_AM_101_in_the_Treatment_of.4.aspx#F1

Hope you find some quiet and that it clears up for you.

 

@OddV thanks for that information. That does look more encouraging than reading some of the personal accounts here. It is hard for me to determine the severity of the T since everybody's perception of it is different--I notice that when I'm feeling bad or down about it, it sounds louder, and when I'm focusing on other things that I hardly notice it. What other accounts have you read about positive experiences? Again it might be a moot point with the myringitis. And I've also read other literature about tympanoplasty and how that can ease tinnitus--so it is sort of a tough choice.

Actually what has been the most comforting thing overall is hearing about other people with it and how they are still living normal lives--that was my biggest fear right away was that I could not enjoy the things I used to enjoy, like playing with my son, hanging out with my wife, listening to music, running, following sports. I know now that that's not true--all of those things are still in my life. And my ENT had a med student who told me her husband also has tinnitus, which somehow really normalized the idea that lots of people have it and it doesn't mean their life is over for me.

 

Day 2 Injections Report (November 6, 2014)
Had trouble falling asleep last night, I attribute that to having too much adrenaline in my system yesterday. I took several laps around the hotel, but it still took me a good 1.5 hours to fall asleep. I had to take Tylenol last night due to some minor pain.

T was all over the place when I laid down, ranging from a 2 to an 8 .... Had to mask using crickets. I swear it disappeared a few times, but it could be that I was focusing on the crickets and forgot about it.

Ear felt very full this morning... I woke up with T, which is normal for me. From waking up to injections, the T is the same tone/volume as is normal for me.

I can't pop my ears, which is annoying and was very concerned about getting water in my ear while taking a shower. I did buy some silicon shapeable ear plugs just for showering.

The day started off with another hearing test (shorter this time and just tested my left ear) and then the balance test.

Trial coordinator came in and asked me if I had any side effects and to describe the severity.

Doctor came in a bit later to check my ear, the hole had already closed up, so got to have topical anesthesia again (yippie). Ear canal was very sore when he was looking in there.

Suctioning out the anesthesia was annoying again, but not quite as bad as yesterday as I knew what to expect. The injection itself WAS more painful today. Yesterday is was 2/10, today it was 4/10.

Ear feels very full... Tinnitus is constant tone, however, the volume does seem lower as I type this. My own test on whether or not this helps is a) do I have it upon waking up and b) how loud is it upon waking up. Personally, I think I'll know whether or not I got the placebo by mid next week. Based on the report I linked above, improvement started showing up in day 2 after the injections (I'm assuming this is after the 3rd injection). @NewGuy... Have you noticed any change in yours?

Will report back tomorrow after day 3.

 

My t is still up and down, some times I don't hear it at all some times its its loud. Its been about 3 weeks since my injections

 

I go to the Iowa study center, I really like the people there and the doctor is a great guy. I thought about just living with it as I was also fully functional in everyday life, but then I figured I didn't have anything to lose by trying as it has been proven safe. Tough choice to make though. I am sure you will be fine either way. I just didn't want to look back and say "what if".

 

Great, thanks for the info @NewGuy. Good to know that they are a good place and a good doctor--I was really impressed with the nurse I talked to there. I am based in Minneapolis so it is about a 3 1/2 hour drive to Des Moines, so if I did it I'd have to be away from my family for a few days which would be tough, unless they came with me which might not be the worst thing, either. When will you find out if yours is the placebo or the real deal?

 

You won't find out until the trial is concluded, data analyzed and report published from what I've been told. You do have the option to move into the second part of the trial where you are guaranteed the drug.

If you do it, I'd recommend taking someone with you... If your kids are younger, you'd probably not want to bring them.... It's a lot of sitting around waiting.

 

Thanks @OddV...I have a 1 year old who is pretty active and would definitely be bored by sitting around for a long time. If I do it I might just have to bite the bullet and be away for a few days during the part where they do a few days in a row. At least they pay mileage and hotel fees, it sounds like, and my drive would be one I could make fairly easily in a day.