AM-101

Ah thanks everyone. I've actually applied for the am101 trial. I've spoke to the surgeon yesterday in fact. But as i haven't been to ENT yet, i don't think i'll be accepted. Thanks anyway for the link. Perhaps after ENT, and i don't get accepted, i'll apply again.

 

Not sure if this has already been discussed but read this today.

http://www.dailymail.co.uk/health/article-2692010/Gel-stops-constant-buzzing-ears.html

 

This is Am-101 , I am pretty sure.

 

Hi all,

i have tinnitus since march 2014. It started after I had some earaches and fulliness unfortunately my ENT doesn´t found any reason why i get this funny sound. He told me that it may be stress inducted tinnitus because i have been very busy at this time (study, full time work...).

Now i have the chance to join the study with medication AM-101. But I am not sure if I should do that because they found no reason for my Tinnitus. What do you think, should I join it or is it senseless to join it? Do you know why only people with specific reasons for tinnitus could join the study?

Thank you for your help

Greetings, Mavrik

 

Hi everybody

Auris Medical sent me an email back.



AM-101 comes 2017 to the Market !!

I think that are good news. If they can help People with acute tinnitus.... than maybe it is not far away to help people with chronic tinnitus

And they are starting to test AM102.. for chronic suffers.

greetings

 

Sorry, but the above e-mail from Auris Medical Holding AG is a conditional statement.

It - the statement - contains the word "if"...

 

and when it comes 2018 it is also okay

 

This is about presenting accurate information to the forum.

The e-mail says "...if all goes well, then AM-101 will hit the market in 2017...". So it is not a question of whether it is in the year 2017 or 2018. It is a question of whether the drug will hit the market at all (hopefully it will).

I also do not see a mention of the e-mail (or any other information) describing news of AM-102; to my knowledge, there is no official information that AM-102 will be tested soon. Of course, it could be true (I hope so), but there is a difference between "claiming something" and "knowing something".

 

according to my brother he works as a general praticioner at paris hospital. AM101 is not promising. T is a brain thing and not ear thing

 

Then how does he explain the positive results from phase 2?

 

tinnitus is not only a brain thing.

and the capability of am101 is not full exhausted. auris medical wrote me that am101 can be much more effective than it is now.

 

Alright, I know this thread has been here for a long time, but I still have to make a decision about going forward with the injections in a week and a half. By looking at all of the posts, I'm still very unsure because there doesn't seem to be a lot of positive regarding AM-101. My guess is that if no one on this post is reporting any success or positive stories with AM-101 trials, it is because there isn't any. It would be surprising that all of the people that participated to the AM-101 trials on TT received the placebo.

I'm getting slowly habituated (20-30%) and reporting my T level for the next 3 months doesn't seem like a good idea, especially if the treatment doesn't worth it. All I see on threads on AM-101 is negativity from the participants.

So, I would really really really appreciated if people that will see that message could report on the outcomes of their experience with AM-101.

Right now, It think that I will take a pass since I haven't seen anything convincing. The results of the Phase 2 study are not "earthshaking" as others have already said as they are based on self-reports. They could find anything with their primary outcome measure (Minimum Masking Level) and they reported improvement even for the placebo group (not such a big difference between the placebo and treatment groups). I'm a researcher and I always doubt results that are based on self-reports and such a small sample of participants.

I think that the numerous anecdotal stories on T habituation are far more convincing than the ones on the AM-101 trial.

Alright, so again, I'm asking participants that went through the AM-101 to report on the outcomes (positive, negative or neutral about it) to help a fellow T sufferer to make his decision regarding his participation to the study. This board is meant to help each other and I feel like I'm left in the dark. I really really need some advice.

A million thanks to those of you who will answer this post. It will clearly also help others to make their decision towards AM-101 participation.

You can also report your experience on this thread.

https://www.tinnitustalk.com/threads/am-101-participants-updates-and-q-a.6558/

Thanks!

 

In Spain we are going to start with AM 101.

 

I'm still curious myself

 

I participated in the Phase 3 Clinical Trial for AM-101 (Esketamine) from Auris Medical. I did get the placebo--at least I assumed I did because I had no improvement. But 84 days later, they gave me the drug (in early Dec of 2014). Seven days after the third injection, I noticed that the loudness of my tinnitus had gone down. Over the following several weeks, it continued to go down. The drug is a miracle!! It lowered the loudness of my tinnitus by 50%. And when they put me in the sound booth, the tests also showed that the loudness was down by about 50%. I went ahead and got a second round of injections (in early March of 2015), to see if they would lower the loudness further, but they did not seem to do so. But the fact is, this drug works. I also think that the loudness may still be going down some. I barely notice it anymore. The only time I think about it is when I lay down to go to sleep and the room is really quiet. But I no longer need my white noise machine to fall asleep. I actually stopped using that machine about 30 days after I got the drug, because I no longer needed it. I encourage everyone to get these injections. Only catch is...you can't have your tinnitus more than 3 months. The quicker you get the drug into the inner ear, the better the chances of getting rid of the tinnitus. AND... they say that the reduction in loudness is permanent. It sure seems so, for me. I think the Phase 3 Clinical Trial is closing soon, so if you just got tinnitus, PLEASE look on the internet and find out where you can enroll and do it today. This drug from Auris Medical is a miracle. It gave me my life back. It really did. P.S. It does not hurt to get the injections because they put some Novacaine cream into the ear canal first, to numb the eardrum. But I will tell you that it is somewhat frightening when the doctor releases the drug, because you feel a cool, web glob, dripping in the middle of your head. But do as I did...remember that this weird feeling only lasts about 10 seconds. Hey...10 seconds of that is WELL WORTH a lifetime of less tinnitus. Some people (about 25%) say that the drug takes their tinnitus away 100%. I think that if I had got the drug instead of the placebo, back in September, it may have gone away 100%. The drug did not get onto my cochlea until 4 months after onset, and yet it still reduced the loudness of my tinnitus by 50%. THAT IS SO WONDERFUL AND I AM SO GRATEFUL. That's why you have to act asap, if you just got tinnitus. This study will end soon. The drug should be on the market in 2016 or 2017.

 

Guess I am shit out of luck, then!!

 

That's of course assuming it doesn't work at all after 3 months. I think this drug has the potential to replace the seemingly hit or miss prednisone treatments often prescribed or recommended here after acoustic trauma. I imagine the drug would work better within a few days after onset than 1 or 2 months.

 

I'm a noob when it comes to AM-101, could someone please tell me which phase they are in (if tested on several places, tell me which place has the highest phase number and what number that is), and how many phases that are expected to take place.

Overall, how is AM-101 doing? Mostly positive reports? Mostly negative reports?

And if AM-101 is successful it will come to markets 2017 or 2018?

And is it something called AM-102?

 

It sure is, but < 3 months is a large market if you count with everyone who are about to get T but hasn't got it quite yet. But I doubt that AM-101 will be given to everyone even if it is successful, at least here in Sweden. ENT: s seems to love the fact that they could just wave their hand in the air like T isn't a problem, and then send the patient home again.

 

And also:

• Would it be possible and safe to use AM-101 a second time? If it cured T one time, but you still got it a second time from e.g. a new acoustic trauma?

• Would it be possible for people suffering from chronic T to use AM-101 if their T were to worsening after e.g. a new acoustic trauma? It's easy to imagine that the same process were to start then, just like it did when one first got T.

 

Some people here had multiple rounds of injection so I'm inclined to say it is safe for multiple uses.

 

I see, like multiple treatments with AM-101? What I mean is that AM-101 maybe isn't effective or safe to use over and over again, even if one single treatment is with several injections. But I guess you are right, I wasn't thinking clearly when I posted what you quoted.

 

Is there any way to become part of the clinical trial if you're from Sweden? Any information would be greatly appreciated!

 

try to contact aurismedical.com to see if there's a possibility

 

Not to be pessimistic. I read the post. I am aware that some people have reported great improvement, others not so much. Moreover unrepresentative data, involving the reduced sample in relation to the total of people involved in the trial.

What scares me most is the risk of hearing loss arising from any intratimpanic treatment. In the Phase II there reported some cases.

You know something? It would be terrible to use AM 101 to relieve tinnitus and hearing loss experience.

Options are low, but they exist, and scary.

 

I have been reading about AM-101. It seems that all trials are closed. Does anyone have any information about its availability? It is available in any other countries, etc.?

I have had T for 1.5 weeks and eager to take some sort of action sooner rather than later.

Thanks in advance.

 

AM101 failed. But you've only had T for 1.5 weeks... you are still within the short time window in which prednisone can help you. If I were you I would see an ENT and get on some ASAP.

 

I think i read an announcement of AM101 clinicals continuing into late 2017!

 

Thank you. I have an appt with the ENT 12/07, but called and spoke and suggested prednisone and started that yesterday. I have a 7-day dosage at 40 mg/day.