AM-101 TACTT1 Results Released

[jazz]

@t-man

I'm basing my observation on what my audiologist told me and what I've read. I've just included a 2007 research study about this and some information from the BTA on hearing aids and tinnitus. Some people with tinnitus may also benefit from specific hearing aid settings. I need to find reference to this; when I do, I'll post.

Please see my observations on the link below on hearing aids and tinnitus. You need to go to the last page; I'm latest post titled How hearing aids may help reduce tinnitus:

https://www.tinnitustalk.com/threads/hearing-aids.676/page-11#post-39749

 

[st0rch]

Well, I have my little theory that T is like this:

View attachment 1050

You need 3 things for it to arise, remove ONE, and it goes away. Fix the brain, but not the cochlea= cured. Fix the cochlea but not the rain = cured

Or remove the brain.

 

[tomytl]

News from Auris Medical
http://www.aurismedical.com/p/news/news_44.php?lg=en

 

[JohnG]

Yeah...pretty much either you fix the brain (and hence not really fix the root problem) or you fix the root problem...ergo...fix the damage in the cochlea. 99.999 percent on this board have T from damage to the nerves in the cochlea (even if you hear like a wombat) because at some frequency you damaged the nerves and or hair cells. That is where the problem is. Anything else is just a gimmick like most of medicine...always fixing symptoms but no cure.

At lease AM-101 will be a fix of the symptom near the source but still not a cure. For that, we need hair cell regeneration..full stop.

 

[Erlend]

"At Day 90, the mean improvement in tinnitus loudness was 48% in the high-dose group, compared to 28% in the low-dose group and 9% in the placebo group. Overall, 64% of patients in the high-dose group rated their tinnitus severity at Day 90 compared with baseline as ''much improved'' or ''very much improved,'' compared with 44% and 35% of patients in the low-dose and placebo groups, respectively."

This is AWESOME. Double the dose and you have a cure???

 

[JohnG]

If I read the formulation right, AM-101 has hyaluronic Acid as the vector substrate. That may also be a good thing in and of itself. Hyaluronic Acid can help cell growth. Even if I got the placebo, that would not be too shabby a deal. Hyaluronic Acid is used in Germany with corticosteriods with some success too.

 

[Hudson]

"At Day 90, the mean improvement in tinnitus loudness was 48% in the high-dose group, compared to 28% in the low-dose group and 9% in the placebo group. Overall, 64% of patients in the high-dose group rated their tinnitus severity at Day 90 compared with baseline as ''much improved'' or ''very much improved,'' compared with 44% and 35% of patients in the low-dose and placebo groups, respectively."

This is AWESOME. Double the dose and you have a cure???

No. Without getting into the math of the bioavailability of active substances, I would imagine it's similar to a logarithmic scale, where it reaches a plateau of effectiveness. That's why they are doing repeated treatments instead of large doses. You can keep a sustained exposure of the drug to the inner ear a lot better that way than with a large single dose.

 

[nills]

Ok, install an am-1o1 ear pump and flood the ear for a month

 

[Owch]

Ok, install an am-1o1 ear pump and flood the ear for a month

Yes, I'm a bit surprised that they are using syringes instead of pumps to apply the treatment

I seem to remember reading that Caroverine was applied via an osmotic pump in the clinic in india which offers that treatment

 

[Hudson]

Yes, I'm a bit surprised that they are using syringes instead of pumps to apply the treatment

I seem to remember reading that Caroverine was applied via an osmotic pump in the clinic in india which offers that treatment

I can tell you why. Tympanopunction procedures have been used in the ENT field for many, many years. Doctors already perform this many thousands of times a year around the world. The safety of this procedure is well documented. If you're trying to get approval for a drug, why waste R&D time and effort trying to get a biomedical device approved at the same time? Leave that to a biomedical company who is interested in that.

@ResonanceCEO's company is researching a device that potentially could be used to deliver any kind of medication in a sustained fashion to the middle/inner ear if I understand correctly. He would be able to provide some good insight there.

 

[Owch]

I can tell you why. Tympanopunction procedures have been used in the ENT field for many, many years. Doctors already perform this many thousands of times a year around the world. The safety of this procedure is well documented. If you're trying to get approval for a drug, why waste R&D time and effort trying to get a biomedical device approved at the same time? Leave that to a biomedical company who is interested in that.

@ResonanceCEO's company is researching a device that potentially could be used to deliver any kind of medication in a sustained fashion to the middle/inner ear if I understand correctly. He would be able to provide some good insight there.

That sounds resonable, thank you!

 

[Mark Washington]

Has any of the trials started in the USA yet? It seems like these people are having a difficult time starting up.

 

[Hudson]

Has any of the trials started in the USA yet? It seems like these people are having a difficult time starting up.

http://www.tinnitus-study.info/us-en-study-centers

Yes, they are and are recruiting now. You could probably participate in the trial at the Des Moines site if you live in Minnesota, assuming you are willing to drive. You may want to contact the Mayo clinic in Rochester, they may be participating but might not be listed on that site. If you would like the contact information for the 3rd party business who is conducting the study for Auris in Des Moines, I can give you that if you would like in a PM.

 

[JohnG]

They say they are coming to Western Canada by middle of April. I'm only 3 hours from the site and they will contact me when ready. I hope all goes on time b/c of the 3 month window.

 

[dan]

Is 3 years still in the time bracket ? Also, if I say my tinnitus is 3 weeks old, how would they know ? lol

 

[t-man]

At lease AM-101 will be a fix of the symptom near the source but still not a cure. For that, we need hair cell regeneration..full stop.

Hey, it's a cure for me. We all age, we all loose our hearing. I'll gladly give up some hearing for silence.

Is 3 years still in the time bracket ? Also, if I say my tinnitus is 3 weeks old, how would they know ? lol

I know you're joking but please don't sabotage medical data.

 

[JohnG]

Hey, it's a cure for me. We all age, we all loose our hearing. I'll gladly give up some hearing for silence.

I know bro...I know.....silence is a beautiful gift even if it is a band-aid. Plaster that baby on me!

 

[James White]

Ok guys, there is a very high chance that i'm on AM101 trial. I'll have the 3 injections at the end of this month after a preliminary test that is in 10 days. The hospital doing the study is around 15 minutes from where i live and is one of the most highly ranked hospitals in France !

Plus i'll be right at the end of the inclusion criteria, so i guess it's "chronic stable unilateral tinnitus"

i'll keep you posted

 

[Hudson]

Ok guys, there is a very high chance that i'm on AM101 trial. I'll have the 3 injections at the end of this month after a preliminary test that is in 10 days. The hospital doing the study is around 15 minutes from where i live and is one of the most highly ranked hospitals in France !

Plus i'll be right at the end of the inclusion criteria, so i guess it's "chronic stable unilateral tinnitus"

i'll keep you posted

You're lucky that you have the opportunity to take part in the "post acute" stratum B study in the EU. The studies in the US are only for up to 3 months of onset. Godspeed, good sir!

 

[Rog]

@jazz let me know if i understood. does it only work for people with less than 3 months tinnitus? Does it work for disabling tinnitus people ? My name is Rogerio i am new here and would appreciate your response . Thank you

 

[jazz]

@jazz let me know if i understood. does it only work for people with less than 3 months tinnitus? Does it work for disabling tinnitus people ? My name is Rogerio i am new here and would appreciate your response . Thank you

@Rog Hello!

By disabling tinnitus, I believe you mean loud tinnitus. Regardless of its loudness, AM 101 should help reduce your volume. I'm sure individual responses will vary, but you have every reason to be hopeful!

Regarding length of time for AM 101 to be effective, the current US trials are for people with tinnitus less than three months old. But in Europe they are testing the drug for people with tinnitus up to 12 months. This is trial TACTT3. (see http://clinicaltrials.gov/ct2/show/NCT02040194?term=tinnitus&recr=Open&rank=14)

Future trials might extend the twelve month window to anyone with chronic tinnitus. Right now, we just don't know.

It is likely the drug will benefit most people with tinnitus--whether acute <3 months or chronic >12 months. Time will tell if the drug's effectiveness will diminish the longer you have tinnitus. For example, it is possible that after a year most people will get some improvement in their tinnitus, but the noise won't be gone. This is because the ear is only one component of tinnitus; the other component is in your brain. That said, it is also possible that once your ear is stabilized by the drug, your brain will slowly unlearn the tinnitus sounds and you will be effectively cured.

I would not worry about time periods at this point; the future for AM 101 looks bright for all tinnitus sufferers!

In the meantime, you might try some treatments recommended on TT to help you with your loudness. It takes patience and time. But nearly everyone improves over a six-month period. I was very loud for several months, but I'm much better now. So look around and see if you find advice that might help you on your healing journey.

And I see you've only had tinnitus since February. If you haven't seen a doctor, you should. It's possible the doctor might find a physical cause for your tinnitus that he or she can cure.

 

[Rog]

@jazz Thank you very much for this helpfull and well explained response. I got ear infecttion in january and after seen my ENT and put on antibiotics , the infecttion went away leaving a very low T in my left ear and the sensation of fullness .

That was okay once i learned the tricks with white noise . On frebruary i caught cold and fever . With no knowledge took some aspirins ... Bam. After that my Tinnitus went high and really hard to cope. Had difficult to sleep , eating and very anxious. Normal simptoms of tinnitus as we all know.

I am originally from brazil but leaving in NYC for 7 years Decided that with -15 celsius degree would be harder do recover . Here i am with family which has been very important . I ve seen 3 ENT and 2 neurosurgeon and I've had MRI and nothing came out. The doctors said that the tinnitus can stay or be gone . I have two different sounds in my ear/head . One is a high pitch and the other one i would describe as pulsatile . I am going to have a angiogram test this week .

I am new here and found more information than visiting doctors . One more time thank you for you time and i am sorry for my english . Hope all is well.

 

[JohnG]

@jazz Thank you very much for this helpfull and well explained response. I got ear infecttion in january and after seen my ENT and put on antibiotics , the infecttion went away leaving a very low T in my left ear and the sensation of fullness .

That was okay once i learned the tricks with white noise . On frebruary i caught cold and fever . With no knowledge took some aspirins ... Bam. After that my Tinnitus went high and really hard to cope. Had difficult to sleep , eating and very anxious. Normal simptoms of tinnitus as we all know.

I am originally from brazil but leaving in NYC for 7 years Decided that with -15 celsius degree would be harder do recover . Here i am with family which has been very important . I ve seen 3 ENT and 2 neurosurgeon and I've had MRI and nothing came out. The doctors said that the tinnitus can stay or be gone . I have two different sounds in my ear/head . One is a high pitch and the other one i would describe as pulsatile . I am going to have a angiogram test this week .

I am new here and found more information than visiting doctors . One more time thank you for you time and i am sorry for my english . Hope all is well.

This site will probably give you more info than your doctors, sadly. I wish I had gone on this site a week or so after my onset. I would have known about all the treatments much earlier. Instead, I trusted family docs and emerg docs that know about as much about the pathophysiology of hearing as a truck mechanic. One "doctor" told me it was just stress and all I needed was yet another ototoxic pill called celexa for depression (well I wasn't depressed then but I damn sure am now)...and the other quack told me it was withdrawal symptoms from a sleeping pill I came off of. So basically, I never saw the train coming and no professional was there to help (despite seeking it a week after I had T). That is why sites like this are better than the best medical school or residency. I'm barely going to make the 3 month window for AM-101, but thank God for this site I might make it. I want Mr T out of my life!! And I hope that for you too.

 

[Hudson]

This site will probably give you more info than your doctors, sadly. I wish I had gone on this site a week or so after my onset. I would have known about all the treatments much earlier. Instead, I trusted family docs and emerg docs that know about as much about the pathophysiology of hearing as a truck mechanic. One "doctor" told me it was just stress and all I needed was yet another ototoxic pill called celexa for depression (well I wasn't depressed then but I damn sure am now)...and the other quack told me it was withdrawal symptoms from a sleeping pill I came off of. So basically, I never saw the train coming and no professional was there to help (despite seeking it a week after I had T). That is why sites like this are better than the best medical school or residency. I'm barely going to make the 3 month window for AM-101, but thank God for this site I might make it. I want Mr T out of my life!! And I hope that for you too.

I hope the AM-101 treatment works out for you too. Even if you get placebo in the first study, you will be guaranteed to get 3 treatments at 90 day intervals for the next study if you wish to participate in the follow up study (which I would in a heart beat).

 

[JohnG]

I hope the AM-101 treatment works out for you too. Even if you get placebo in the first study, you will be guaranteed to get 3 treatments at 90 day intervals for the next study if you wish to participate in the follow up study (which I would in a heart beat).

I wasn't sure of that but that is good to know. Even if I cross that magical (and somewhat contrived) 3 month line, I think I would still benefit from it. So that is an excellent insurance policy. Thanks for confirming that.

 

[Hudson]

I wasn't sure of that but that is good to know. Even if I cross that magical (and somewhat contrived) 3 month line, I think I would still benefit from it. So that is an excellent insurance policy. Thanks for confirming that.

Get your ass in there and get the process going. They are sticklers about that 3 month mark here in the US. I'm not even joking.

I mean that in the best possible way. I would hate to have you miss out on the opportunity.

 

[JohnG]

Get your ass in there and get the process going. They are sticklers about that 3 month mark here in the US. I'm not even joking.

I mean that in the best possible way. I would hate to have you miss out on the opportunity.

Just waiting for the email from the contact at Auris. She keeps telling me to hold on. It will be probably the middle of this month but they have two locations only 3 hours from my place by car. She assures me the process moves fast. I sure the hell hope so. But that magical line might be getting a little blurry if they wait too long ;=) Thanks!

 

[jazz]

Just waiting for the email from the contact at Auris. She keeps telling me to hold on. It will be probably the middle of this month but they have two locations only 3 hours from my place by car. She assures me the process moves fast. I sure the hell hope so. But that magical line might be getting a little blurry if they wait too long ;=) Thanks!

You'll be fine! You've been in contact with Auris so I can't see a problem. And you're so early into the tinnitus symptoms that you'll probably be cured!

All the best!

 

[DaveT]

They say they are coming to Western Canada by middle of April. I'm only 3 hours from the site and they will contact me when ready. I hope all goes on time b/c of the 3 month window.

Hello JohnG and everyone else here, I just learned about AM-101 from here, where did you get this information that they are coming to Western Canada by middle of April? I am located in Ontario.
I just found this website recently so I am new here. I was told by my ENT to try and get used to my tinnitus and that looking for "cures" would make me lose my sanity. Do you have a link to another website or email I can contact?
Thank you!

 

[JohnDoe]

Recently found an article about AM-101 in the specialist journal Otology & Neurotology:

Full article in source: http://journals.lww.com/otology-neu...d_Safety_of_AM_101_in_the_Treatment_of.4.aspx

ABSTRACT

Objective

To evaluate the efficacy and safety of intratympanic AM-101 in patients with persistent acute inner ear tinnitus after acute acoustic trauma, idiopathic sudden sensorineural hearing loss (ISSNHL), or acute otitis media.

Study Design

Prospective, double-blind, randomized, placebo-controlled study with follow-up visits on Days 7, 30, and 90.

Setting

Twenty-eight European sites (academic tertiary referral centers and private ENT practices).

Patients

248 patients aged 16 to 65 years.

Interventions

Three intratympanic injections of AM-101 (0.27 or 0.81 mg/ml) or placebo over 3 consecutive days.

Main Outcome Measures

Efficacy was assessed by changes in minimum masking level (MML; primary end point), loudness match, tinnitus loudness, tinnitus annoyance, and sleep difficulties on a 0 to 100 numerical rating scale, THI-12 questionnaire, and patient global impression of change. Safety was evaluated using the frequency of clinically relevant hearing deterioration and adverse events.

Results

The study overall failed to demonstrate a treatment benefit based on the change in MML. However, AM-101 0.81 mg/ml showed statistically significantly better improvement for tinnitus loudness, annoyance, sleep difficulties, and tinnitus impact in patients with tinnitus after noise trauma or otitis media. The subgroup of ISSNHL-related tinnitus patients did not show conclusive results. The study drug and I.T. injections were well tolerated.

Conclusion

The study established proof of concept for AM-101 in the treatment of tinnitus arising from cochlear glutamate excitotoxicity. Patient-reported outcomes seem to be more relevant and reliable efficacy measures for assessing treatment-related changes in tinnitus than psychoacoustic tests.