You see, 9 holes. So probably +3 holes too much?
Anyhow, you are right I shouldn't have responded to @Stink 's comment. I made my point of view about this study crystal clear. Nonetheless, I wish all trialees here good luck.
AM-101 Clinical Trial — Participants Updates and Discussion
- Thread starter NewGuy
- Start date
You see, 9 holes. So probably +3 holes too much?
Anyhow, you are right I shouldn't have responded to @Stink 's comment. I made my point of view about this study crystal clear. Nonetheless, I wish all trialees here good luck.
@Matt h
@OddV
@NewGuy
@Laika
@tomm
@EarsKid
@Chelovek
@sergerold
Hi guys,
Just to know for those who have done the trial and have had some relief/benefit in term of intensity from the 2nd round of injection (the real drug), in which time frame did you noticed this benefit (quietness) ? 2 weeks, 3 weeks or 4 weeks ?
Cause i'm 2 weeks from the 2nd round of injection, and things just start to come back as it was before.. I feel the aircraft is still about to land.
So how long did it took you to feel something better after the 2nd set of injection ?
@OddV
@NewGuy
@Laika
@tomm
@EarsKid
@Chelovek
@sergerold
Hi guys,
Just to know for those who have done the trial and have had some relief/benefit in term of intensity from the 2nd round of injection (the real drug), in which time frame did you noticed this benefit (quietness) ? 2 weeks, 3 weeks or 4 weeks ?
Cause i'm 2 weeks from the 2nd round of injection, and things just start to come back as it was before.. I feel the aircraft is still about to land.
So how long did it took you to feel something better after the 2nd set of injection ?
Member
Hi Roman,
You are a bit in the same airplane as me. Second injections did nothing.
As this drug has best chances within onset of T 3months. Beyond that stage i think its effect is questionable.
Don't worry. Start TRT.
Best Robb
My onset was less than 2 months ago, so I'm strongly considering.
however as I see it:
1) Nobody on here has mentioned stellar results. Maybe they're all just so free and clear they'd rather not be on a tinnitus forum anymore.
2) Chance of placebo, ear full of liquid multiple times, and multiple tympanic holes is scary, no matter what the statistics say. The reason I got into this predicament to begin with is my Eustachian tubes not releasing pressure, what if I go on a flight with the placebo gummed up in there and it gets worse?
3) Has anyone established whether or not there's a statistical significance with use of the drug vs spontaneous recovery?
however as I see it:
1) Nobody on here has mentioned stellar results. Maybe they're all just so free and clear they'd rather not be on a tinnitus forum anymore.
2) Chance of placebo, ear full of liquid multiple times, and multiple tympanic holes is scary, no matter what the statistics say. The reason I got into this predicament to begin with is my Eustachian tubes not releasing pressure, what if I go on a flight with the placebo gummed up in there and it gets worse?
3) Has anyone established whether or not there's a statistical significance with use of the drug vs spontaneous recovery?
1) I've had results, I do believe the 2nd round helped me (reduced the perceived loudness by around 40% within 1 week).... Did it cure... No
2) Valid concern, the placebo/medicine should be fully absorbed 2 weeks after injections... Can you wait that long after having them?
3) I don't know
2) Valid concern, the placebo/medicine should be fully absorbed 2 weeks after injections... Can you wait that long after having them?
3) I don't know
Did you have good and bad days before the therapy? Could it be possible this is placebo percentage? Don't get me wrong, I hope you get better but I also hope if one of the next days your T volume rises, you will tell us about it. Let's hope you have a defended improvement and it stays that way.
Its about time I updated. I got my first AM-101 injections a little more than two weeks ago.
At about two weeks I would say my T was back to what it was before injections. From the people ive communicated with, they all have noticed a spike. They all said it went down.
When I started AM-101 I was about a 3. Now I am sometimes a 2(it seems to be in the mornings), but still a 3. My hope is in a reddit post about acoustic trauma (gunshot) like me, who said his faded completely away after a month+ time after the drug. Thats if I got the real thing.
As for my hearing, its "normal" but I do have high frequency hearing loss, and a "notch" at 4000hz but its still in the "normal" range. My T tone from doing matching myself is 4000hz. Putting 1 and 2 together, looks like that notch is causing my T.
At about two weeks I would say my T was back to what it was before injections. From the people ive communicated with, they all have noticed a spike. They all said it went down.
When I started AM-101 I was about a 3. Now I am sometimes a 2(it seems to be in the mornings), but still a 3. My hope is in a reddit post about acoustic trauma (gunshot) like me, who said his faded completely away after a month+ time after the drug. Thats if I got the real thing.
As for my hearing, its "normal" but I do have high frequency hearing loss, and a "notch" at 4000hz but its still in the "normal" range. My T tone from doing matching myself is 4000hz. Putting 1 and 2 together, looks like that notch is causing my T.
Where is this reddit thread? This forum seems to be very inactive in its discussion of AM-101
Its an inactive thread but here. http://www.reddit.com/r/tinnitus/comments/1m1kiy/follow_up_on_am101_study_i_participated_in/
I go Tuesday for my final checkup for 2nd round and get my injections for the 3rd round.... I'll update as always on progress.
I get them 3 days in a row, so T-Th unless I have the temporary catastrophic hearing loss again.
I get them 3 days in a row, so T-Th unless I have the temporary catastrophic hearing loss again.
Thanks.
Very much want more feedback like @grandfunk1 on whether or not it worked for them...
I can't tell whether or not mine will heal over the next year naturally or if I should go for the experimental treatment..
My study doctor told me that he thinks the drug would not have an affect on any natural healing that would happen. Believe me i asked many times. I trust him, he said the only worry he had was if the hole in the ear drum doesnt close which hasnt ever happened. Hes in research. He performed the gene therepy procedure. Its best to get started as soon as possible. I got my injections right after 1 month of onset, so when i forsure get the drug in the ampact trials itll be only about 4 months from onset.
A side bonus would be the free hotels/gas money/spending money for doing the trial. Its given me alittle bit of a vacation every time i go for a study visit.
Also of course helping with research and future T suffers feels good. Fuck tinnitus!
Also of course helping with research and future T suffers feels good. Fuck tinnitus!
SoulStation
Member
The 4000 Hz tone is probably causing the dip in your hearing because the t signal interferes with your overall hearing. So in other words you have it backwards. Good luck with the trials mate. much love.
SS
That could be it. Didn't think of that. It is hard to hear some tones in the audiogram because of the eeeeeeeeee going on in my ear.
Thank you, ill probably be having my eardrum pierced a total of 12 times before im done.. Yay..
Thank you, ill probably be having my eardrum pierced a total of 12 times before im done.. Yay..
3rd round, 1st injection... No different than all the others... Getting to be old hat now. Had drainage last night, not as muffled as the last go around. About the same in terms of tenderness.... Almost fell asleep during my 30 minute wait.
- Aug 14, 2013
- 2,455
- Tinnitus Since
- Resolved since 2016
- Cause of Tinnitus
- Unknown (medication, head injury)
Thanks for continuing to share your experience with TinnitusTalk. I believe you are one of the very few who has stayed with the board and reported on your progress through all the stages: the trial itself, 1st round with AM-101, and 2nd round with AM-101, if I understand you correctly.
Although I could be mistaken, the willingness to provide post-trial injections also proves Auris Medical's commitment to the patients of the trial as they - Auris Medical - are not required to provide follow-up treatment with the real drug, as far as I know (and also represents a not insignificant cost burden to Auris Medical). Question of mine in this respect: do you still do any self-reporting to the doctors in terms of improvements you experience (I wonder as the treatment is no longer blinded, of course, and hence has little "official relevance" I would imagine)?
Thanks for your insights!
@attheedgeofscience, That's correct...
TACTT2 was the "official" blinded trial - I'm about 90% convinced I got the placebo in this trial due to several observations that I've made regarding my reaction to the injections, the substance itself, and also reverse engineering the results from TACCT1 and feeding my own results into the model.
I'm now on AMPACT1, which is the companion trial, and I just did the 4th injection yesterday, 7th injection in total(start of second round on this trial). It's basically a safety study IMO while providing potential benefit to the patient.
Now that we have the terms above defined. On TACTT2 I had to report daily my loudest and annoyance via the electronic diary. During each follow up exam, I had to do two longer electronic surveys, one of which was PGIS.
On AMPACT1, I do not have to do the daily report, but during the follow up exams, I do have to do the longer electronic surveys. They ask questions, such as, over that past two weeks, has the pitch of your tinnitus changed, the loudness changed, has it affected your life, work, ability to concentrate, etc, etc. so they are still capturing information.
Also, I'm very very tired of having hearing tests.
TACTT2 was the "official" blinded trial - I'm about 90% convinced I got the placebo in this trial due to several observations that I've made regarding my reaction to the injections, the substance itself, and also reverse engineering the results from TACCT1 and feeding my own results into the model.
I'm now on AMPACT1, which is the companion trial, and I just did the 4th injection yesterday, 7th injection in total(start of second round on this trial). It's basically a safety study IMO while providing potential benefit to the patient.
Now that we have the terms above defined. On TACTT2 I had to report daily my loudest and annoyance via the electronic diary. During each follow up exam, I had to do two longer electronic surveys, one of which was PGIS.
On AMPACT1, I do not have to do the daily report, but during the follow up exams, I do have to do the longer electronic surveys. They ask questions, such as, over that past two weeks, has the pitch of your tinnitus changed, the loudness changed, has it affected your life, work, ability to concentrate, etc, etc. so they are still capturing information.
Also, I'm very very tired of having hearing tests.
- Aug 14, 2013
- 2,455
- Tinnitus Since
- Resolved since 2016
- Cause of Tinnitus
- Unknown (medication, head injury)
haha...!
One further question, if I may. I have myself attempted to get treated with AM-101 and OTO-311 off-trial via an ENT surgeon who is part of the AM-101 trial here in Germany (I am Danish, and hence not allowed to participate in the official trial). When I went to see the doctor in person a year after my initial visit, I was surprised to learn that he had only treated two patients during that entire time period. The ENT surgeon could therefore not provide much insight in terms of efficacy as he only had two cases to go on (which of course are blinded to him as well, but still). I wonder if you have any impression as to whether the doctors treating you are 'more busy' and if so, do they have any gut-feeling as to efficacy of AM-101 (e.g. have they had any of the trial patients saying they have had a total elimination of their tinnitus, for instance)?
Thanks.
@attheedgeofscience as of right now, I'm the only individual that made it through the screening and onto the trial at my trial site. They've had a couple of people that got close but DQ'd for some reason or another.
They do share the # of enrollees with me, sounds like Auris is at about 50% of goal for TACCT2 right now (that info is about a month old though).
They do share the # of enrollees with me, sounds like Auris is at about 50% of goal for TACCT2 right now (that info is about a month old though).
haha...!
One further question, if I may. I have myself attempted to get treated with AM-101 and OTO-311 off-trial via an ENT surgeon who is part of the AM-101 trial here in Germany (I am Danish, and hence not allowed to participate in the official trial). When I went to see the doctor in person a year after my initial visit, I was surprised to learn that he had only treated two patients during that entire time period. The ENT surgeon could therefore not provide much insight in terms of efficacy as he only had two cases to go on (which of course are blinded to him as well, but still). I wonder if you have any impression as to whether the doctors treating you are 'more busy' and if so, do they have any gut-feeling as to efficacy of AM-101 (e.g. have they had any of the trial patients saying they have had a total elimination of their tinnitus, for instance)?
Thanks.
I asked the head of the U.S. trial that same question, and he said it's too early to say yadda yadda but that it shows some promise .. I couldn't get more than the stock, press-friendly answer
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