AM-101 TACTT1 Results Released
- Thread starter Hudson
- Start date
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SteveToHeal
Member
Hi guys,
How difficult is it to get through the screening? My understanding is that they check your blood, do hearing and tinnitus masking tests and then an e-diary for 2 weeks after day 1 and you say how your T is in the e-diary.
I can't see how you can fail the screening. Or did i miss something?
How difficult is it to get through the screening? My understanding is that they check your blood, do hearing and tinnitus masking tests and then an e-diary for 2 weeks after day 1 and you say how your T is in the e-diary.
I can't see how you can fail the screening. Or did i miss something?
hi all,
another update today.
Went to the hospital and had a big discussion with the doctor about getting the real am101 for both ears instead of just my right ear. In the end i got injected in both ears with the real stuff.
Going for seconds and thirds tomorrow and the day after.
another update today.
Went to the hospital and had a big discussion with the doctor about getting the real am101 for both ears instead of just my right ear. In the end i got injected in both ears with the real stuff.
Going for seconds and thirds tomorrow and the day after.
SteveToHeal
Member
@khu85 @Bart Marien @locoyeti @robs @earsnothappy
Hi guys,
How difficult is it to get through the screening? My understanding is that they check your blood, do hearing and tinnitus masking tests and then an e-diary for 2 weeks after day 1 and you say how your T is in the e-diary.
I can't see how you can fail the screening. Or did i miss something?
Hi guys,
How difficult is it to get through the screening? My understanding is that they check your blood, do hearing and tinnitus masking tests and then an e-diary for 2 weeks after day 1 and you say how your T is in the e-diary.
I can't see how you can fail the screening. Or did i miss something?
i had to do the following:
pee in a bottle
letter from the doctor who said i had an ear infection
blood
e-diary for 2 weeks
temperature
blood pressure
tinnitus loudness (based on other sounds they let you hear)
hearing check-up
questions how severe your tinnitus is and how your look at life is
i could not have taken any drugs at all. A lot of people with tinnitus take anti depressants. (including me before the trial. i had to quit a month before it started)
pee in a bottle
letter from the doctor who said i had an ear infection
blood
e-diary for 2 weeks
temperature
blood pressure
tinnitus loudness (based on other sounds they let you hear)
hearing check-up
questions how severe your tinnitus is and how your look at life is
i could not have taken any drugs at all. A lot of people with tinnitus take anti depressants. (including me before the trial. i had to quit a month before it started)
i also heard from the doctors in the hospital that a lot of people cancel their shots at the last minute cause they are scared from the needle injection in the eardrum.
SteveToHeal
Member
Thanks Bart. What did you say "how you look at life if you don't mind me asking?" I guess they want to see you improve over time. So from really bad, to better or much better, after the drug.
SteveToHeal
Member
You get questions like:
How depressive does your tinnitus make you
How do you feel about your tinnitus etc
How depressive does your tinnitus make you
How do you feel about your tinnitus etc
SteveToHeal
Member
Thanks Bart. Did you just say makes you depressed and you feel bad about your T?
you need to give a number from 0-10 on all these questions think it are about 15 questions in total
- Aug 14, 2013
- 2,455
- Tinnitus Since
- Resolved since 2016
- Cause of Tinnitus
- Unknown (medication, head injury)
Thank you for sharing your input. I have essentially left this thread (many pages ago!), but I just wanted to make a brief comment. I do believe your feedback is a first - as this - your 2nd treatment round will obviously confirm the efficacy of the treatment to a much larger degree because 1) it is the real drug and 2) both ears are treated.
I think this is an important point, and it is also something I "sense" from other posts on this forum eg. the Retigabine thread. There is a pharmacological paradigm in medicine which roughly states something like "you cannot have a front-effect without also having a side-effect". This is the nature of medicine and medical procedures (of today). I always favour action over inaction. "Inaction" means a person has not decided which side of the fence they are on. Every human being will be faced with uncertainty at some point in their life. And we will all have to make decisions with only limited information at some point in our lives too - be it taking on a new job, going on a date, or joining a tinnitus clinical trial. If a person is not willing to take a limited risk, then don't get involved in the first place. Two weeks ago I had my eardrums examined (for the "10th time") at the Acquaklinik, but this time on a video monitor because I wanted to see for myself if I could find any evidence from having had ear tubes inserted as a child. Indeed, there were still small scars visible some 30 years later. Having tubes inserted is not uncommon in childhood, and if we could handle it as children, then doing it as an adult should be a "piece of cake".
So most importantly: you decided to get involved. And I hope that you will be rewarded for your decision.
@SteveToHeal
The first screening if you will was a basic questionnaire that my doctor gave to me to fill out. Since my doctor is apart of the study, I didn't have to submit any paper work as he confirmed everything and I did a hearing test at his office which confirmed that I had hearing loss.
The questions ranged from, did you have tinnitus for the last two weeks, to has the pitch changed etc. Various questions in regards to how loud it may be, what sort of a sound it seems like, if it is one noise or multiple noises. I assume dependent on your answers you can be removed from the trial before it begins.
The actual first evaluation where I went to the office was more or less basic review of these questions but this time I had to answer them again and in a bit more detail. Describing the noises I hear, etc. Basic blood work, Hearing test, and a doctor screening to rule out any issues. I assume to rule out any other medical issues you may or may not have that could cause the results to vary. They also go over that you are not allowed to take any herbal, supplements or medicines that are recommended for tinnitus. Lipoflavinoids (I know they dont work) but you cannot take them, as well as some other medicines I have to check the list but if you are in the screening they will give you a card)
Last they give you an electronic diary in which you fill out questions each night. You must answer it each might (I almost forgot to enter last night actually). It is to monitor to check I suppose your progress throughout the 100 days.
I will update once I get my first injection on Monday.
The first screening if you will was a basic questionnaire that my doctor gave to me to fill out. Since my doctor is apart of the study, I didn't have to submit any paper work as he confirmed everything and I did a hearing test at his office which confirmed that I had hearing loss.
The questions ranged from, did you have tinnitus for the last two weeks, to has the pitch changed etc. Various questions in regards to how loud it may be, what sort of a sound it seems like, if it is one noise or multiple noises. I assume dependent on your answers you can be removed from the trial before it begins.
The actual first evaluation where I went to the office was more or less basic review of these questions but this time I had to answer them again and in a bit more detail. Describing the noises I hear, etc. Basic blood work, Hearing test, and a doctor screening to rule out any issues. I assume to rule out any other medical issues you may or may not have that could cause the results to vary. They also go over that you are not allowed to take any herbal, supplements or medicines that are recommended for tinnitus. Lipoflavinoids (I know they dont work) but you cannot take them, as well as some other medicines I have to check the list but if you are in the screening they will give you a card)
Last they give you an electronic diary in which you fill out questions each night. You must answer it each might (I almost forgot to enter last night actually). It is to monitor to check I suppose your progress throughout the 100 days.
I will update once I get my first injection on Monday.
@SteveToHeal
The important point to note here as @khu85 mentioned is that they want your trial starting point to be like when you first got T. You have to essentially discontinue anything you are doing to reduce the effects of T on your life - medications, supplements, acupuncture, and they even told me white noise maskers.
They want you in your most raw form to really determine after the trial if the AM-101 drug has impacted your T in any way (or no way, if you possibly received the placebo).
If you admit to (or get tested) doing anything mentioned, they would/should not let you participate because it could throw off the results.
SteveToHeal
Member
update: its been over a month i've had am-101 and the overall volume is still down, but i am still having my fluctuations. i don't feel as though there has been significant improvement since the few weeks after my ears healed, in fact i would say that it is slightly returning back to baseline in terms of fluctuations, but the overall volume is still down, so i am happy about that.
got my last injection today. my ears feel a lot more clogged then last time and the tinnitus is much louder then last time that i got the injections.
guess it's because i got both ears injected now instead of just one.
guess it's because i got both ears injected now instead of just one.
@Bart Marien
Hi Bart, I understand that you have finished your trial and that you will be participating to the follow up study where you will be given the actual drug.
I have my first appointment in 2 weeks with the doctor in charge of the trial where I live. Maybe you can help me with these questions:
-i have tinnitus since oct 2013 (acoustic trauma ) so I had it for nearly 10 months now. Since i'm approching the 12 months limit do you think I will be able to take part in the follow up study and be given the real drug, just in case i got the placebo in the first round. Do they ask for you to still be in the 12 months limit to take part in the follow up?
- i have no hearing loss clearly visible on my audiogram, my ENT beleives I did loose some hearing in the very high frequencies < 8000hz. Do they request a clear hearing loss visible in normal audiograms?
Thanks!
Hi Bart, I understand that you have finished your trial and that you will be participating to the follow up study where you will be given the actual drug.
I have my first appointment in 2 weeks with the doctor in charge of the trial where I live. Maybe you can help me with these questions:
-i have tinnitus since oct 2013 (acoustic trauma ) so I had it for nearly 10 months now. Since i'm approching the 12 months limit do you think I will be able to take part in the follow up study and be given the real drug, just in case i got the placebo in the first round. Do they ask for you to still be in the 12 months limit to take part in the follow up?
- i have no hearing loss clearly visible on my audiogram, my ENT beleives I did loose some hearing in the very high frequencies < 8000hz. Do they request a clear hearing loss visible in normal audiograms?
Thanks!
if you do the first study you can do the follow up study.
I also had no visible hearing loss. They actually needed people with no hearing loss and tinnitus that came by noise or an ear infection
I also had no visible hearing loss. They actually needed people with no hearing loss and tinnitus that came by noise or an ear infection
Well today's the day for me for my 1st injection and I will say that I am very nervous about it - but not because I'm getting a needle in my ear.
The last month and a half have been a roller coaster for me. My T started on June 30th. I was scared, had anxiety, saw three EMTs, got an MRI, and was prescribed steroids and anxiety meds.
However, once I got past the initial anxiety, I started learning to live with it - i.e., beginning the habituation process. Right now, I'm in a pretty good place. While the T is still there, I'm not really noticing it during the day anymore. At night it is still very present, but I am masking it with white noise so I can sleep.
My fear with starting the AM-101 trial is centered around undoing the progress that I have made over the past month.
Like everyone else, I do want the ringing to go away forever. But I don't want to be in a worse place post-injections than I am right now.
Fundamentally - is the reward worth the risk?
Yes, in my opinion it is. If you do not take part, and you know you have passed up the opportunity, if/when AM-101 gets approved and is used on acute cases, you'll be kicking yourself for not having tried it when you had the opportunity.
@robs
I am going in for my first injection in an hour or so. I completely understand what you are feeling, plus I am
also nervous of the side effects it may have.
I have learned to cope with tinnitus and the fact that I have some hearing loss over the past 2 months but like many have said, I would regret it if I didn't try my best to help my future. I feel that until I have exhausted all options, I will never fully be complacent with having tinnitus.
Where are you doing your trial by the way?
Good luck. Fingers crossed we both get the real drug
I am going in for my first injection in an hour or so. I completely understand what you are feeling, plus I am
also nervous of the side effects it may have.
I have learned to cope with tinnitus and the fact that I have some hearing loss over the past 2 months but like many have said, I would regret it if I didn't try my best to help my future. I feel that until I have exhausted all options, I will never fully be complacent with having tinnitus.
Where are you doing your trial by the way?
Good luck. Fingers crossed we both get the real drug
I really don't think am-101 has much efficacy, I think it might have a bit on acute cases, but since hes already doing so well only a month in, all having his ears plugged up is going to do is increase the sound and potentially undo his habituation- all to take a drug which had poor results in round 2, they literally tortured trial data to show some efficacy among acute, 1 sided patients- and those results were still not too impressive- its a trial based on piggy-backing the fact that most tinnitus patiens get better 2-5 months after onset, and then they take that population and slice and dice trial data to try to show a little better increased efficacy for the drug vs placebo
@khu85 , Good luck to you as well. If you are able, please post back following your injection.
My trial is in Havertown, PA at 4:00pm eastern time.
People here are gonna say yes so you can report back. But you gotta do what u think is right.
But this is a pretty rare opportunity, wouldnt want to look back and regret...
SteveToHeal
Member
Hey guys. To get on the trial you have to do T Loudness and T Annoyance every night on the ediary. Do you just answer the same every night, if your T is tonal and constant? I can imagine it must not move too much to track it properly. So on a scale of 1 to 10, how bad is your T? I think most people on this board would rate 8, 9 or 10. And the same for every night thereafter.
Thanks @Erlend .
Just to close the loop, I decided at the doctor's office not to proceed with the trial. I felt that it just wasn't the solution for me. It is a long commitment (because I would have definitely participated in the follow up trial). From what I read from others in this thread, the follow up trial with the actual drug still didn't reduce the ringing completely in most cases.
I am closely watching the Potiga thread and may try that option.
@SteveToHeal , regarding your post, I did the daily diary for almost three weeks and never reported loudness higher than 7 and annoyance higher than 6.
@robs
Sorry to hear that, but I hope you the best in the future.
I had my first injection today. I would like to say that the staff that has been working with me is wonderful.
On to the details for today. We started around 1pm today with regular paperwork and a check up. We did regular blood pressure etc, and a drug screening (urine test). Following that they checked my eyes using these goggles and then my ears.
We then proceeded to go take another audio test to confirm that there were no changes in my hearing. This time however we did tinnitus matching to check the loudness of my tinnitus. This was rather difficult as the tone used is much lower in pitch than my tinnitus so it was a bit difficult to accurately describe the volume of the tinnitus.
Moving on to the shots. I would have to say that I had my doubts at this point but for me I feel that I would not be able to feel fully comfortable unless I tried all my options.
I have to say that the shot was far more painful than people have said it was. I assume the anesthesia used did not work very well because I could feel a sharp pain as the needle entered and the medicine was administered. I felt slight dizziness for about a minute once the medication entered. It was a strange feeling and my ears felt full. There was a slight pain / discomfort as I waited for the 30 minute to pass.
Post shots I honestly couldn't say I feel very different. I don't feel that my hearing or my ears feel too full. I can operate pretty normally. I hope that doesn't mean I didnt get the real medicine.
I will update as I get my 2nd , 3rd shot and each follow up visit.
Sorry to hear that, but I hope you the best in the future.
I had my first injection today. I would like to say that the staff that has been working with me is wonderful.
On to the details for today. We started around 1pm today with regular paperwork and a check up. We did regular blood pressure etc, and a drug screening (urine test). Following that they checked my eyes using these goggles and then my ears.
We then proceeded to go take another audio test to confirm that there were no changes in my hearing. This time however we did tinnitus matching to check the loudness of my tinnitus. This was rather difficult as the tone used is much lower in pitch than my tinnitus so it was a bit difficult to accurately describe the volume of the tinnitus.
Moving on to the shots. I would have to say that I had my doubts at this point but for me I feel that I would not be able to feel fully comfortable unless I tried all my options.
I have to say that the shot was far more painful than people have said it was. I assume the anesthesia used did not work very well because I could feel a sharp pain as the needle entered and the medicine was administered. I felt slight dizziness for about a minute once the medication entered. It was a strange feeling and my ears felt full. There was a slight pain / discomfort as I waited for the 30 minute to pass.
Post shots I honestly couldn't say I feel very different. I don't feel that my hearing or my ears feel too full. I can operate pretty normally. I hope that doesn't mean I didnt get the real medicine.
I will update as I get my 2nd , 3rd shot and each follow up visit.
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