AM-101 Clinical Trial — Participants Updates and Discussion
- Thread starter NewGuy
- Start date
Stu
Member
- Apr 12, 2015
- 16
- Tinnitus Since
- 01/04/2015
- Cause of Tinnitus
- Noise Induced Trauma - Concert
I've had 2 rounds of injections and I can assure you the decision of having tympanic injections was not something I took lightly.
I therefore did my research prior to making that decision and found although many people experience hearing loss and an increase in Tinnitus volume post injection, this is temporary… the reduction in hearing is (or in my case) due to the amount of fluid remaining trapped between the middle and inner ear which blocks external sound but which also dissipates over time.
Yes, there is always the possibility that you COULD be permanently worse off but there aren't any case studies that indicate that this has happened – after all this is a trial that is at Phase 3 and I think it's important to make a distinction between supposition and fact.
Of course the decision is very much down to the individual, I'm simply posting a participant update as per the thread title and as a real life example that may or may not assist others in their decision making process.
MemberGiven the nature of the drug and the mecanisms of T induction the authors have published this is hardly surprising.
You think I am also 101 not work for chronic? Or you have any hope? Maybe could relieve a little T ...
How sad ... I had a lot of hopes on AM 101
How sad ... I had a lot of hopes on AM 101
I think there's absolutely no chance AM-101 will work for long term tinnitus. It was not designed for such and the targeted receptors don't seem to have any implications in central tinnitus, if such thing exists.
They do however have AM-102 in the works which we know next to nothing about. It would strike me as odd to have 2 drug candidates in the pipeline for the same end effect.
Ih AM102 success in cure of chronic t, than AM101 is gonna be useless... Thing that cure chronic t will for sure cure acute t. That is my opinion, it seems to have a logic..
I recently received my first set of AM-101 (or placebo) injections, at just about 3 months of tinnitus due to acoustic trauma. The procedure has been pretty well documented in this thread so I won't go into it.. but just wanted to add my name to the list. I'll report back on any changes. (No notable negatives or positives to report as of now.)
Hi guys. I am enrolled in the AM101 study and am scheduled to have my injections october 15th-17th. I am a little confused because everyone here is talking about "rounds". What do you mean by rounds? From the information I was given, there are three shots (with 60% chance getting drug and 40% getting placebo) and then three months later you are available to do an open label study with the actual drug (another three shots) Is this what everyone is referring to as the second round? the open label study? and if so are we allowed a third round three months after? Thanks just a little confused here.
You can have a total of four rounds of injections. Each round is a series of three injections. The first one is 60/40 drug or placebo, the 2nd, 3rd, 4th are all drug with no placebo.
Last week Thomas Myer, CEO of Auris addressed potential investors about their upcoming products. He mentioned that they made a preliminary examination of the incoming AM-101 trial data last Spring and it appears that the drug loses its efficacy for injections made approaching the 12 month mark, and therefore they are focusing their efforts on studying the 3-6 month period. It sounds like after 6 months the viability of the drug falls off. Therefore it appears the best outcomes are for patients who have the injections in the first six months since onset. It may work past six months in some patients, but my takeaway is they are hoping to get approval for its use in the first six months.
John Meyers
Member
- Oct 7, 2015
- 364
- Tinnitus Since
- 09/2015
- Cause of Tinnitus
- Just One (1) Loud Rock Concert!
I have read through most of the comments on this thread and am just over 3 weeks with my steady high-pitch tinnitus from a incredibly loud 3-hour concert (that I never should have attended).
Before learning about AM-101, I researched T a lot and found that 80% of newbie T suffers who experienced T from a one-time event usually recovered 100% within 12 months.
Since AM-101 participants can only enroll in their first 3 months of experiencing T, maybe the results we are seeing are skewed because many of these folks would be recovering/habituating anyway in month 6, 7, 8, 9, etc.. (and are mistakenly thinking that their recovery is a result of AM-101)?
Sorry for being the devil's advocate. -- I see that a lot of you are really suffering and just wanted to throw that out there before I decide whether or not to jump on the AM-101 train.
Before learning about AM-101, I researched T a lot and found that 80% of newbie T suffers who experienced T from a one-time event usually recovered 100% within 12 months.
Since AM-101 participants can only enroll in their first 3 months of experiencing T, maybe the results we are seeing are skewed because many of these folks would be recovering/habituating anyway in month 6, 7, 8, 9, etc.. (and are mistakenly thinking that their recovery is a result of AM-101)?
Sorry for being the devil's advocate. -- I see that a lot of you are really suffering and just wanted to throw that out there before I decide whether or not to jump on the AM-101 train.
The study is double blinded. Anything significant over the placebo baseline would be attributed to the drug. Past AM-101 results were already posted here.
https://www.tinnitustalk.com/thread...dates-and-discussion.6558/page-20#post-119473
You can't look at the results individually as a clear picture only comes to light after taking the placebo into account as Nucleo mentioned. Based on the phase II studies and also my own survey of previous participants the drug helps perhaps 25% of participants getting the drug that would not have gotten better on their own.
As for the 80% that is a bit general. I think that depends upon the severity of damage. I went to a single concert, the first in my life and I received some hearing damage verified by an audiologist. If you have damage, chances are tinnitus will stick around. The odds of it clearing on its own diminish with time. After a couple of weeks there is a good chance it is not going away.
If you are thinking of participating, don't think about it too long because they are planning on wrapping up the trial by the end of the year. I suppose soon they will stop accepting new patients.
Lloyd Carter
Member
80% might recover within 12 months after a one time event, but the GRAND majority of those are within a week, MAYBE two. The first post I ever read by @Markku (our fearless leader) was that after you've had your T for more than a couple of weeks, it's likely there for good. Yes, there are cases when it goes, but statistically, it's probably there to stay.
What happened to the survey that was use to be connected to this thread concerning AM-101? I went to fill it out and it was gone. Was that removed as part of an agreement for Auris to sponsor the site?
Minor potential side effect here. I had the injections 2 weeks ago, and the volume of my tinnitus seems to get a touch louder with my pulse - did anyone else experience this? Before the injections I didn't notice my T being affected by my pulse at all. I'm thinking maybe I still have some fullness which is affecting it, but I'm not sure. Anyways, like I said its nothing major, but figured its worth mentioning.
I had my first injection of the second round of AM-101 today.
Something magical happened. In the seconds following the injection my tinnitus completely ceased to zero for 2-3 minutes. It was completely gone. Not even a hint of a tone. Then in cranked back up over the following minutes and within 15 minutes it was screaming. It was a beautiful couple of minutes while it lasted.
Something magical happened. In the seconds following the injection my tinnitus completely ceased to zero for 2-3 minutes. It was completely gone. Not even a hint of a tone. Then in cranked back up over the following minutes and within 15 minutes it was screaming. It was a beautiful couple of minutes while it lasted.
- Aug 14, 2013
- 2,455
- Tinnitus Since
- Resolved since 2016
- Cause of Tinnitus
- Unknown (medication, head injury)
A Personal Appeal From Myself Regarding Misinformation...
This week, and also the last one, has seen some sad news: The Autifony Therapeutics QUIET-1 study was terminated prematurely due to lack of efficacy. Less noticed to many - probably - was the news regarding Otonomy and their upcoming OTO-311 phase-I trial - which - has now been confirmed, but only for healthy volunteers (not patients). In addition, a media attack was launched on SciFluor Life Sciences by the hedge fund Kerrisdale Capital - which may have implications down the road. All-in-all, not a good past week for the worldwide tinnitus community.
With the above in mind, it saddens me to read misinformation from various random posters regarding the AM-101 phase-III trial. Right now, and for the foreseeable future, there is really only one pharma company left to help the tinnitus community: Auris Medical AG. It does the entire tinnitus community a disservice when posters feel the need to post seemingly randomly picked information to the effect of "tinnitus is a 'brain thing', therefore AM-101 will not work" and "there is a risk of permanent hearing loss if you enroll in the trial". Speculation has never helped anyone. Leave out the fiction, and stick with the facts.
In terms of facts, Auris Medical and physicians involved in the trial have already willingly spent their time addressing questions from members of TinnitusTalk. These Q&A-sessions can be found here:
Lastly, I will attach various peer reviewed papers on the AM-101 study. If you want facts, then read those - not the all the hearsay and background chatter.
Misinformation can sometimes influence the decision a person makes as to whether to enroll in a trial. It would be sad that a person decided against enrollment based on the wrong information only to endure life-long tinnitus. So again, and in the interest of everyone, stick with the facts.
I hope that there will be ambassadors of this forum willing to ensure that facts, not fiction, dominate the decision making in this thread. Thank you.
attheedgeofscience
14/OCT/2015.
Tags: @SoulStation @billie48 @OddV
This week, and also the last one, has seen some sad news: The Autifony Therapeutics QUIET-1 study was terminated prematurely due to lack of efficacy. Less noticed to many - probably - was the news regarding Otonomy and their upcoming OTO-311 phase-I trial - which - has now been confirmed, but only for healthy volunteers (not patients). In addition, a media attack was launched on SciFluor Life Sciences by the hedge fund Kerrisdale Capital - which may have implications down the road. All-in-all, not a good past week for the worldwide tinnitus community.
With the above in mind, it saddens me to read misinformation from various random posters regarding the AM-101 phase-III trial. Right now, and for the foreseeable future, there is really only one pharma company left to help the tinnitus community: Auris Medical AG. It does the entire tinnitus community a disservice when posters feel the need to post seemingly randomly picked information to the effect of "tinnitus is a 'brain thing', therefore AM-101 will not work" and "there is a risk of permanent hearing loss if you enroll in the trial". Speculation has never helped anyone. Leave out the fiction, and stick with the facts.
In terms of facts, Auris Medical and physicians involved in the trial have already willingly spent their time addressing questions from members of TinnitusTalk. These Q&A-sessions can be found here:
- www.tinnitustalk.com/threads/am-101-trial-q-a.10629
- www.tinnitustalk.com/threads/auris-medical-q-a.8201/#post-94826
Lastly, I will attach various peer reviewed papers on the AM-101 study. If you want facts, then read those - not the all the hearsay and background chatter.
Misinformation can sometimes influence the decision a person makes as to whether to enroll in a trial. It would be sad that a person decided against enrollment based on the wrong information only to endure life-long tinnitus. So again, and in the interest of everyone, stick with the facts.
I hope that there will be ambassadors of this forum willing to ensure that facts, not fiction, dominate the decision making in this thread. Thank you.
attheedgeofscience
14/OCT/2015.
Tags: @SoulStation @billie48 @OddV
Thanks for the heads up. I for one will never trash a study for the benefit of the T community. I used to mention Autifony and AM-101 to really suicidal newbies about the new drugs on trial so they know there are other options out there coming. Too bad Autifony will not be in the picture now. But even if there is one potential drug out there being tested, it is already a big boost to the struggling newbies.
ruben ruiz
Member
Man, Am-101 looks nice on a graph, high pillars and whatnot
Huge, significant pillars.
Having gone through the trial and I am 90%+ positive I got the real drug the first time around because of some esketamine side effects I enjoyed from the 3rd injection... numb face, slurred speech, highness.
My tinnitus was loud and sound sensitive until about the 4th week after injection. It settled down and my sound sensitivity ceased. My volume lowered and the lower frequency sounds ceased. I was left with high frequency ringing and an occasional buzzing.
However, about three weeks before the end of the study my tinnitus volume began creeping up slowly. By the time it ended I was back to baseline, but without the sound sensitivity. I can't say it was an improvement, but I can't say it was worse. If the study had ended three weeks earlier I would say significant improvement, but thus I put no change down in my diary at the end.
I am now in the open label study of the drug. Once I am done with this I will not continue. I set a condition that I would only continue in the open label study if I could receive lidocaine cream (emla) instead of phenol for anesthetizing my drum prior to injection. The phenol healing process was not pleasant as I was quite loud and buzzy. It also takes a long time to heal up. The emla cream is a little uncomfortable to get numbed up and there is a tiny sting upon injection, but I have to say recovery has been wonderful. My intensity is not too bad and my membrane has been closing up each night following the injection. My final injection is tomorrow afternoon.
I am attaching this interesting study done for gacyclidine which in theory interacts similar to the way that ketamine does in the cochlea. This BTW is the active drug for OTO-311 which is entering phase I trials. This non-placebo human experiment used a pump to infuse the drug into the cochlea. What I found interesting is the results from the gacyclidine experiment is comparable to the results I experienced with AM-101. Steady improvement, and then a degeneration to baseline. Plus, as with the gacyclidine study, my lower tones faded. The study also found it was ineffective for those longer term suffers of tinnitus. Auris is finding this to be true with AM-101, perhaps it works within 6 months of onset.
What I found is the volume matching that Auris used in their study is flawed in that it presents a single frequency of sound. When I came into the study my tone was lower, thus I scored quite loud. As my tinnitus tones increased in frequency I scored quite a reduction in volume, when that really was not the case because it became impossible to match the volume I was presented with. To me it seemed almost as loud, but the test would show otherwise.
The mystery with the AM-101 papers is they don't differentiate the level of tinnitus that trial participants came in with. It might be helpful to know if the drug works the same for those suffering intensive as opposed to quieter tinnitus. How does it respond to participants with tinnitus associated to hearing loss as opposed to people without? Hopefully the Phase III study addresses this.
As to why it works with some people and not others my hypothesis is that it is difficult to get the drug into a position where it can infuse into the cochlea. I found some lectures that suggest this is not quite so easy and the current practice inefficient. In the future this process will most likely be accomplished using a pump which does a better job.
As to whether AM-101 is an effective treatment, I would say maybe for acute cases. It won't get rid of the ringing, but it could lower it to tolerable levels for some people.
My tinnitus was loud and sound sensitive until about the 4th week after injection. It settled down and my sound sensitivity ceased. My volume lowered and the lower frequency sounds ceased. I was left with high frequency ringing and an occasional buzzing.
However, about three weeks before the end of the study my tinnitus volume began creeping up slowly. By the time it ended I was back to baseline, but without the sound sensitivity. I can't say it was an improvement, but I can't say it was worse. If the study had ended three weeks earlier I would say significant improvement, but thus I put no change down in my diary at the end.
I am now in the open label study of the drug. Once I am done with this I will not continue. I set a condition that I would only continue in the open label study if I could receive lidocaine cream (emla) instead of phenol for anesthetizing my drum prior to injection. The phenol healing process was not pleasant as I was quite loud and buzzy. It also takes a long time to heal up. The emla cream is a little uncomfortable to get numbed up and there is a tiny sting upon injection, but I have to say recovery has been wonderful. My intensity is not too bad and my membrane has been closing up each night following the injection. My final injection is tomorrow afternoon.
I am attaching this interesting study done for gacyclidine which in theory interacts similar to the way that ketamine does in the cochlea. This BTW is the active drug for OTO-311 which is entering phase I trials. This non-placebo human experiment used a pump to infuse the drug into the cochlea. What I found interesting is the results from the gacyclidine experiment is comparable to the results I experienced with AM-101. Steady improvement, and then a degeneration to baseline. Plus, as with the gacyclidine study, my lower tones faded. The study also found it was ineffective for those longer term suffers of tinnitus. Auris is finding this to be true with AM-101, perhaps it works within 6 months of onset.
What I found is the volume matching that Auris used in their study is flawed in that it presents a single frequency of sound. When I came into the study my tone was lower, thus I scored quite loud. As my tinnitus tones increased in frequency I scored quite a reduction in volume, when that really was not the case because it became impossible to match the volume I was presented with. To me it seemed almost as loud, but the test would show otherwise.
The mystery with the AM-101 papers is they don't differentiate the level of tinnitus that trial participants came in with. It might be helpful to know if the drug works the same for those suffering intensive as opposed to quieter tinnitus. How does it respond to participants with tinnitus associated to hearing loss as opposed to people without? Hopefully the Phase III study addresses this.
As to why it works with some people and not others my hypothesis is that it is difficult to get the drug into a position where it can infuse into the cochlea. I found some lectures that suggest this is not quite so easy and the current practice inefficient. In the future this process will most likely be accomplished using a pump which does a better job.
As to whether AM-101 is an effective treatment, I would say maybe for acute cases. It won't get rid of the ringing, but it could lower it to tolerable levels for some people.
Hi guys.
Had my first shots into the ears today at around 5 o clock. tinnitus has risen from a 3 to a 5 and my hearing is very muffled.
I am worried that I received the placebo because it was not painful- and people were saying before on this thread that receiving the real drug was painful.
Had my first shots into the ears today at around 5 o clock. tinnitus has risen from a 3 to a 5 and my hearing is very muffled.
I am worried that I received the placebo because it was not painful- and people were saying before on this thread that receiving the real drug was painful.
Painful or not painful does not mean you got the drug either way. The drug does not make the procedure more painful. Cutting or puncturing the membrane is what causes the pain, not what goes into it.
thanks man! Really good to hear that. Have my second one today. My tinnitus has gone back down to its original level, which is nice. sitting at about a 3.5 out of 10 right now.
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