AM-101 Clinical Trial — Participants Updates and Discussion
- Thread starter NewGuy
- Start date
Member- Jan 27, 2016
- 229
- Tinnitus Since
- 01/2016
- Cause of Tinnitus
- Noise induced
Give it a bit more time. From what I understand is it can take up to 90 days even if you got the real drug, right? It may be possible that reactive T might happen if you are too overprotective of your ears. I noticed that with my T. Spending too much time away from any sounds or noise, makes me more paranoid that when I do get around a noisy environment my T will spike up and I experienced a couple of occasions where I thought that was happening to me too. Since then I stopped worrying about it I haven't really noticed that as much. I don't shy away from noise anymore.
Thing is I am getting back to those environments I have tend to avoid during the first months. I am not as scared about being in a crowded bar as I did at first. I don't know if I had any sort of H but in the beginning I felt in alert with sounds like dishes and glasses being washed, barks, car horns, etc... Now I feel more confident and even if I still being aware of not to be in too noisy surroundings I feel way more confident handling everyday situations.
Well, despite behaving in that way I have been experiencing reactive T all this time. Have to say that today my T seems to be more maskable than never before and hasn't reacted as it has done all the past times. Hope it settles here but this crap changes constantly...
Thing is I am getting back to those environments I have tend to avoid during the first months. I am not as scared about being in a crowded bar as I did at first. I don't know if I had any sort of H but in the beginning I felt in alert with sounds like dishes and glasses being washed, barks, car horns, etc... Now I feel more confident and even if I still being aware of not to be in too noisy surroundings I feel way more confident handling everyday situations.
Well, despite behaving in that way I have been experiencing reactive T all this time. Have to say that today my T seems to be more maskable than never before and hasn't reacted as it has done all the past times. Hope it settles here but this crap changes constantly...
Can do nothing but love your coments, support, communication and approach. Thanks again, mate.
Hi guys,
I have participated to the Auris Medical study on the second week of February in Switzerland. I got 3 injections of either placebo or AM-101. So now I am one month, after the injection and I do not noticed any difference with my tinnitus. It is true that some day the frequency of my tinnitus is changing a little. Sometime there is a "pulsatile tinnitus" coming but it disappear after few hours. Overall there is no change. Tinnitus is 8/10.
I will have a follow-up meeting next week with the doctors.
Side effect : as many people mentioned, tinnitus increase a lot 3-4 days after the injection. But it come back to the base after.
Positive points : I understand how a clinical study is working and I am getting familiar with injection into my ear.
If you have any questions, feel free to send my a private message.
Take care.
Noun
I have participated to the Auris Medical study on the second week of February in Switzerland. I got 3 injections of either placebo or AM-101. So now I am one month, after the injection and I do not noticed any difference with my tinnitus. It is true that some day the frequency of my tinnitus is changing a little. Sometime there is a "pulsatile tinnitus" coming but it disappear after few hours. Overall there is no change. Tinnitus is 8/10.
I will have a follow-up meeting next week with the doctors.
Side effect : as many people mentioned, tinnitus increase a lot 3-4 days after the injection. But it come back to the base after.
Positive points : I understand how a clinical study is working and I am getting familiar with injection into my ear.
If you have any questions, feel free to send my a private message.
Take care.
Noun
Louise77
Member
- Nov 24, 2015
- 13
- Tinnitus Since
- 10/11/2015
- Cause of Tinnitus
- Loud headphones? Don't know....
I have filled out the online study questionnaire two times for one of the UK study centres. The first time was 2 weeks ago, I got the email to say my form had been successfully received and that they would be in touch with me. No reply since, no contact.
I then filled it out again 4 days ago, again got the email to say they would be in touch. No reply since.
It doesn't fill me with confidence that they can't even get back to people who have applied for the study.
I then filled it out again 4 days ago, again got the email to say they would be in touch. No reply since.
It doesn't fill me with confidence that they can't even get back to people who have applied for the study.
Sebastians
Member
- Jan 12, 2016
- 375
- Tinnitus Since
- 10/2015
- Cause of Tinnitus
- Guitars, loud girls and guns
Got first injections. The numbing hurt a little but the injection didn't. Felt dizzy after injection for a minute. Swallowed a few times but the drug did not drain. Left ear (second ear they injected) still feels full of stuff after an hour. Right ear feels less full, maybe because I was lying on my side while left ear was settling?
- Jan 27, 2016
- 229
- Tinnitus Since
- 01/2016
- Cause of Tinnitus
- Noise induced
I'm glad you had yours done, and I just had my first injection too today. I pretty much had the same experience @TorDog had. Great detailed post he made here. Mine was painless. In fact, I had a positive reaction. My T gradually got lower form the moment I got in, during the audio tests to the point I was ready for my injections it basically disappeared in my right and lowered in my left as well.
Then, to my surprise, my T went totally silent after the doctor used the vacuum to remove the numbing agent, in both ears, my left as well. It's back to about a 1 in my left now, still totally silent in my right, but I had a good hour of wonderful silence in both ears, in a very silent room, while waiting for 30 minutes on each side. I have no idea how effective AM-101 will be or if I got the placebo, but I really want another round of the numbing agent and vacuum because that was great and gave me instant relief.
The doctor checked my tonsils but today they didn't hurt or felt swollen and didn't see anything to think much of my symptoms that I have been experiencing. However, once again, I keep experiencing differences between my left and right ear. My right cleared up right away within 30 minutes and I could feel it draining down my throat, numbing my tongue and cheek. My left, where I keep experiencing these symptoms, and my T is loudest, still hasn't cleared up, and I also did not feel it drain while swallowing. Something is going on with the left side of my face/throat/tonsil/sinuses. It was also the 2nd ear they did for me too.
So far I am not experiencing a loudness increase others have reported even though my left ear is completely muffled. It's lower than it was when I left my house this morning. Probably the lowest T day I had in 2 weeks, but again, that started before I got the injections and it's holding.
Still 2 more to go, but I'm definitely glad I went through with this. It's really a simple and painless procedure.
- Jan 27, 2016
- 229
- Tinnitus Since
- 01/2016
- Cause of Tinnitus
- Noise induced
So I wanted to post another update. I took an afternoon nap, and as usual my T returned after sleeping, except it was back in my right ear, surprise! Probably about 1-2, and that's actually the loudest its been in over 2 weeks, and gone in my left! Because obviously that just makes total sense for it to completely reverse itself.... yeah!
But then in about an hour it also died down in my right. And since I have been experiencing 0.5 to 0 in my left and 0 in my right for the past 4 hours. I'm actively listening for it right now in a very quiet room and that's about as high as I'm willing to rate it. 0.5 in my left year, and that's intermittent with 0. I haven't had it this quiet in over 2 weeks and I honestly can't say I remember having periods of total silence in both ears since my third day on Prednisone a month ago.
Maybe this is just a total coincidence once again, but anytime I have total silence that I feel like crying tears of joy I think it's worth noting. The test will be how I wake up after sleeping. Either way, I can't wait to do the vacuum thing again tomorrow. Most people said that they didn't like that part but to me that honestly felt like an itch I needed scratched.
But then in about an hour it also died down in my right. And since I have been experiencing 0.5 to 0 in my left and 0 in my right for the past 4 hours. I'm actively listening for it right now in a very quiet room and that's about as high as I'm willing to rate it. 0.5 in my left year, and that's intermittent with 0. I haven't had it this quiet in over 2 weeks and I honestly can't say I remember having periods of total silence in both ears since my third day on Prednisone a month ago.
Maybe this is just a total coincidence once again, but anytime I have total silence that I feel like crying tears of joy I think it's worth noting. The test will be how I wake up after sleeping. Either way, I can't wait to do the vacuum thing again tomorrow. Most people said that they didn't like that part but to me that honestly felt like an itch I needed scratched.
@Sebastians There is something wrong in my profil, I have to change it. I got high pitch tinnitus since mid of October 2015 so less than 6 months...
My ENT didn't mention anything about not swallowing or yawning or anything during the half hour of waiting after the injections, am I the only who here who experienced this?
- Jan 27, 2016
- 229
- Tinnitus Since
- 01/2016
- Cause of Tinnitus
- Noise induced
Alright, time for my 1 month update after I had the 4 week checkup last Monday.
Sequence of updates:
24 hours after last injection
1 week after last injections
1 month after last injections
2 months after last injections (newly added)
3 months after last injections
So in order to give the best possible overview, I looked up the most commonly asked questions in this section.
5 answers below:
Have you felt any change/improvement/worsening since the injections?
Yes/Yes/No. After about 1 week, I noticed a shift towards one side (as mentioned in my previous post), but T was still above baseline. After two weeks, I realized for the first time that there was an improvement during the day. The relief has further increased over the past two weeks. Temporary spikes (which I used to experience a lot) had totally disappeared between week 1 and 3, but have recently happened more often again.
!BUT! This improvement could have to do with other factors as well. The last two weeks, I was on vacation. No stress, no time at the office (which usually increases T). I should be able to determine this within the next month since I am back to the office for the next 4 weeks. Furthermore, habitation may play a role as well.
Either way, I am very happy about the overall development in my case. So far, my situation has temporarily improved and I am confident that the relief will remain permanently.
Can you quantify the improvement?
Difficult to say. While the loudness has decreased a little (maybe by 30%, from 3/10 to 2/10), the intensity has decreased a lot (more than 50%). The difference is significant enough that now, I can study which earplugs in for several hours without getting regularly distracted (which I previously could not).
Do you believe that you got the real drug or the placebo?
With a 65% certainty, I believe that I got the real stuff.
Have you experienced any lasting (side) effects from the procedure?
None. The procedure sucked, as outlined in my previous post. But after 2 weeks, everything was back to normal. The general increase in T caused by the injections had settled. Holes closed within 72h (my feeling), which was confirmed at the 1 week checkup, in spite of blood crusts on both ear drums which kept the doctor from making a 100% certain statement. At the 4 weeks checkup, the doctor confirmed that everything was fine, noted, however, that there was still a bloodcrust on both eardrums. No reason to be worried though.
Will you participate in the next round?
Not sure yet. But I tend to say Yes. The procedure is intimidating, but that should not be the decicive element. Unless my condition takes a sudden turn, the chances are good that I will do so.
That is my experience so far. I anyone has specific questions, let me know.
Good luck to all the participants!
Sequence of updates:
24 hours after last injection
1 week after last injections
1 month after last injections
2 months after last injections (newly added)
3 months after last injections
So in order to give the best possible overview, I looked up the most commonly asked questions in this section.
5 answers below:
Have you felt any change/improvement/worsening since the injections?
Yes/Yes/No. After about 1 week, I noticed a shift towards one side (as mentioned in my previous post), but T was still above baseline. After two weeks, I realized for the first time that there was an improvement during the day. The relief has further increased over the past two weeks. Temporary spikes (which I used to experience a lot) had totally disappeared between week 1 and 3, but have recently happened more often again.
!BUT! This improvement could have to do with other factors as well. The last two weeks, I was on vacation. No stress, no time at the office (which usually increases T). I should be able to determine this within the next month since I am back to the office for the next 4 weeks. Furthermore, habitation may play a role as well.
Either way, I am very happy about the overall development in my case. So far, my situation has temporarily improved and I am confident that the relief will remain permanently.
Can you quantify the improvement?
Difficult to say. While the loudness has decreased a little (maybe by 30%, from 3/10 to 2/10), the intensity has decreased a lot (more than 50%). The difference is significant enough that now, I can study which earplugs in for several hours without getting regularly distracted (which I previously could not).
Do you believe that you got the real drug or the placebo?
With a 65% certainty, I believe that I got the real stuff.
Have you experienced any lasting (side) effects from the procedure?
None. The procedure sucked, as outlined in my previous post. But after 2 weeks, everything was back to normal. The general increase in T caused by the injections had settled. Holes closed within 72h (my feeling), which was confirmed at the 1 week checkup, in spite of blood crusts on both ear drums which kept the doctor from making a 100% certain statement. At the 4 weeks checkup, the doctor confirmed that everything was fine, noted, however, that there was still a bloodcrust on both eardrums. No reason to be worried though.
Will you participate in the next round?
Not sure yet. But I tend to say Yes. The procedure is intimidating, but that should not be the decicive element. Unless my condition takes a sudden turn, the chances are good that I will do so.
That is my experience so far. I anyone has specific questions, let me know.
Good luck to all the participants!
Some new infos about the follow-up rounds:
As I was informed by the doctor, the number of follow-up rounds has been limited to 1 set of 3 injections after the end of phase III with immediate effect. Apparently the reason is not that it has been restricted for Auris Medical's sake, but because the efforts of participating centres went through the roof.
Furthermore, the follow-up round must be initiated very timely after the last checkup. Not sure if it was 48 hours or 5 days, but it is firmly restricted. So my plan to postpone my "round IV" participation will not work!
The lidocaine used for numbing your ear probably got into your blood during the injection, leading to the silencing of your tinnitus. I had quite a bit of dental work done in October and each of the four days of lidocaine injections gave me 3-4 hours of complete silence.
- Jan 27, 2016
- 229
- Tinnitus Since
- 01/2016
- Cause of Tinnitus
- Noise induced
Yep. That's exactly what it was. It was temporary. I went for my 2nd injections today and they explained it. And I got silence again today after the lidocaine and injections. But if it's so effective why can't we get this in a prescription form at least for bad spikes and temporary relief? Yesterday it was effective before the injection, right when he finished vacuuming. They said it's possible its getting absorbed into the ear drum.
Today the injections were a bit more painful than yesterday. He wanted to first use the same holes, and no lidocaine and I experienced a bit of pain, and then decided to use lidocaine again. It didn't seem to make much of a difference as far as pain goes because it doesn't numb much past the ear drum. So even after the lidocaine I experienced the same pain. My T was still reversed today for most of the day until now, with my left ear silent all day until I slept this afternoon and my right ear between a 1-2. After sleeping its back centered, equal in both ears, and I would say somewhere between a 1-2. My ears are still muffled and clogged up this evening.
Also the way the doctor and assistant was talking, they seemed pretty confident that it's going to come to market, so I guess that's a good sign, but that it's going to be pretty expensive. I asked, and said how expensive, thousands? And they said yeah...easily. And gave an example of the Heapatitis C drug which is some ridiculous amount like $20k. Maybe not that much, but I also probably couldn't have afforded them if it wasn't for this research.
- Jan 27, 2016
- 229
- Tinnitus Since
- 01/2016
- Cause of Tinnitus
- Noise induced
That's interesting. They haven't mentioned that to me but they did mention that AM is doing the 2nd study just to see what happens, because they don't know when it is that far out. I guess it's understandable. At my center I'm having 2 doctors taking turns just because of the scheduling. It must be costing Auris Medical a significant amount to do this research. Great post above and happy to hear you are having good results. I wouldn't hesitate to do the next round myself, unless it disappears by then.
- Jan 27, 2016
- 229
- Tinnitus Since
- 01/2016
- Cause of Tinnitus
- Noise induced
I was hoping someone else here would answer because I feel I'm posting too much in this thread. If you haven't found it yet go here:
http://www.tinnitus-study.info/
If you are interested, don't wait, because they need less than 20 patients before the study closes.
Same, I asked my trial coordinator directly this week and I was told that I would have the option of doing up to 3 followup rounds.
- Jan 27, 2016
- 229
- Tinnitus Since
- 01/2016
- Cause of Tinnitus
- Noise induced
Yeah I asked today again and at my study center they haven't heard anything about Auris Medical limiting the number of rounds. They did mention that they are planning to end the study on March 15th if they get the last few patients they need.
Had my third injection today, and went a lot better than I expected. I thought after feeling some pain yesterday, it would be worse today, but they left the numbing agent on longer today, and I couldn't really feel anything. Was painless. The only thing is fullness and my hearing is pretty awful. He was standing right over my ear talking and I couldn't make out what he was saying. Look forward to that recovering.
They are closing new enrollment on March 15th, not ending the study. The end of March will be the deadline to get the initial set of injections. AMPACT will continue on from my understanding.
Second injection didn't go as smoothly as the first. My ears weren't draining the drug like the first time. After the third injection (it's been 6 hours since) my ears are very full and I can't hear well or hear myself speak well, even after driving through mountains and hearing my ears pop. Tinnitus is very loud.
The dizziness is gone, I think, but the muffled hearing and heavy-ear feeling is still there. How come I didn't have that after the first injection?
- Jan 27, 2016
- 229
- Tinnitus Since
- 01/2016
- Cause of Tinnitus
- Noise induced
That happened to me too. Today they were so stuffed I could barely hear anything after the third injection in my left ear. Seems typical. I was told it could take the entire weekend for that to clear up and that random popping and squeaking could last even a week or two.
Right. That's what I meant.
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