AM-101

[Markku]

What is is the exclusion criteria? The emailed me back and said they will be in Canada in April. But I am just over two months with horrible T now.

http://clinicaltrials.gov/ct2/show/NCT02040194

Exclusion Criteria:

1. Fluctuating tinnitus;
2. Intermittent tinnitus;
3. Tinnitus resulting from traumatic head or neck injury;
4. Presence of chronic tinnitus;
5. Meniere's Disease, history of endolymphatic hydrops, or history of fluctuating hearing loss;
6. History of repeated idiopathic sudden sensorineural hearing loss or history of acoustic neuroma;
7. Ongoing acute or chronic otitis media or otitis externa;
8. Other treatment of tinnitus for the study duration;
9. Known hypersensitivity, allergy or intolerance to the study medication or any history of severe, abnormal drug reaction;
10. Women who are breast-feeding, pregnant or who are planning to become pregnant during the study;
11. Women of childbearing potential who are unwilling or unable to practice contraception, such as hormonal contraceptives, double barrier, sexual abstinence or intercourse with a partner who has been vasectomised for at least three months;
12. Concurrent participation in another clinical study or participation in another clinical study within 30 days prior to randomization.

Other protocol-defined exclusion criteria may apply.

 

[Mark Washington]

The exclusion criteria is on the clinicaltrials.org. John you can always say you got T maybe a month from now. Everyone on earth lies, so anyone saying "I dont lie" is going into the realms of the parodox. They are lieing as they make that statement, so for them moral integrity is probably the lower than the person that admits that they do lie.


Basically they are looking for people with T under 3 months.

They do not want anyone with fluctuating T

They want people to protect their ears.

They do not want anyone whose ear discharged in the past couple of days or are getting other treatmnets.

More can be found on the clincial trial website.

 

[Mark Washington]

Yes the post above me is exact.

 

[Mark Washington]

Grace this drug will not protect you (most likely) from your T getting worse in the future (from say an intense noise). But I agree with you if you can get the treatment, I say go for it. You would get paid 300 dollars.

 

[JohnG]

Thanks Mark. I may try that angle. I have constant, persistent T. I wish it was intermittent. I hope I can get in or get lucky and don't need it. Things don't seem to be looking good.

 

[JohnG]

Thanks Markku for the link

 

[Mark Washington]

John G. A member named KimboSlice might have contact information for a site up by you. He is from Canada to.

 

[JohnG]

Hey thanks Mark. I also just sent an email to the contact for AM-101 and ask her if she knew of any in the state of Washington. I'm in the window...I don't want to loose this.

 

[Stina]

@Grace I dont think they choose people according to how loud it is. You should definitely contact them Even if they say no it couldn't hurt

 

[Grace]

@Grace I dont think they choose people according to how loud it is. You should definitely contact them Even if they say no it couldn't hurt

Okay indeed will

 

[Grace]

Okay indeed will

I read that the criteria says you cant be on anti depressants or anxiety meds? Which i am. And another page i read didnt mention any of those and just said cant be pregnant and other health issues which i dont have and also said willing to use plugs to protect your ears during the process which i would...can anyone help me find the right criteria for this stage 3?

 

[Grace]

Grace this drug will not protect you (most likely) from your T getting worse in the future (from say an intense noise). But I agree with you if you can get the treatment, I say go for it. You would get paid 300 dollars.

Oh damn they pay you? Deff calling on monday

 

[Stina]

I read that the criteria says you cant be on anti depressants or anxiety meds? Which i am. And another page i read didnt mention any of those and just said cant be pregnant and other health issues which i dont have and also said willing to use plugs to protect your ears during the process which i would...can anyone help me find the right criteria for this stage 3?

Call and ask If you want to send an email be sure that you write a title such "participating in this and that area", otherwise they might not read it

 

[cullenbohannon]

Grace where did you see the bit about the meds?

I read that the criteria says you cant be on anti depressants or anxiety meds? Which i am. And another page i read didnt mention any of those and just said cant be pregnant and other health issues which i dont have and also said willing to use plugs to protect your ears during the process which i would...can anyone help me find the right criteria for this stage 3?

 

[Grace]

If i could get this done after may 10th that would probably be too much to ask for but my sis is getting married and i cant NOT go.. So this ill still call and ask questions but probably too late for me

 

[Grace]

Grace where did you see the bit about the meds?

http://clinicaltrials.gov/ct2/show/NCT01934010

 

[Stina]

If i could get this done after may 10th that would probably be too much to ask for but my sis is getting married and i cant NOT go.. So this ill still call and ask questions but probably too late for me

Maybe you could still go but participate in the reception and not in the afterpary? Also you can stay for like an hour and then go home Prob a wedding is not as loud as bar as well. And hopefully its your sisters wedding so maybeyou can negotiate about noise levels.

 

[Grace]

Maybe you could still go but participate in the reception and not in the afterpary? Also you can stay for like an hour and then go home Prob a wedding is not as loud as bar as well. And hopefully its your sisters wedding so maybeyou can negotiate about noise levels.

Yeahh kinda gotta stay the whole time... That would just cause way more drama in my family then there already is.. But i am gonna get custom plugs from my ent so i could always just use them and go outside every 20 mins for a break. Idk im gonna call the site on monday and ask them questions so will see what they say cause the last thing i wanna do is fuck up the experiment..

 

[Stina]

Yeahh kinda gotta stay the whole time... That would just cause way more drama in my family then there already is.. But i am gonna get custom plugs from my ent so i could always just use them and go outside every 20 mins for a break. Idk im gonna call the site on monday and ask them questions so will see what they say cause the last thing i wanna do is fuck up the experiment..

let us know how you do and tell them about the meds

 

[cullenbohannon]

First ent I found that was actually knowledgeable about t . I asked him if he knew about the trials and he had a patient with pretty bad t go and he has had pretty good results. This patient had it pretty bad and could not sleep before the injections.

 

[Brian32]

I was in contact with a doctor in Jacksonville a few days ago about participating in the am-101 trial and unfortunately I was told I did not qualify due to being over 3 months. I am around 4 months at this point. I read on clinicaltrials.gov that they are accepting people who have had tinnitus for up to 1 year in the third trial. I guess the Jacksonville location must have been part of the second trial. Anyways, after looking at tinnitus-study.info/ the closest location to me is in Tennessee. Does anyone know what the cutoff radius is to participate in the study? I am on the Alabama/Florida line which isn't close, but not really that far either.

 

[Hudson]

I was in contact with a doctor in Jacksonville a few days ago about participating in the am-101 trial and unfortunately I was told I did not qualify due to being over 3 months. I am around 4 months at this point. I read on clinicaltrials.gov that they are accepting people who have had tinnitus for up to 1 year in the third trial. I guess the Jacksonville location must have been part of the second trial. Anyways, after looking at tinnitus-study.info/ the closest location to me is in Tennessee. Does anyone know what the cutoff radius is to participate in the study? I am on the Alabama/Florida line which isn't close, but not really that far either.

No, it isn't the Jacksonville location. It is the US. The only studies going above 3 months are in the EU at this time. I was told that the 3 month window was actually at the insistence of the FDA, and that Auris may go back to them and request a higher upper limit if they have trouble finding people who can fit the strict criteria.

 

[Asian]

Do you think AM 101 will be used for chronic/permenant tinnitus at all when it will be available in the future ? The trails are being done only for acute tinnitus and they say it will show no benefit on the chronic T. So if it's available in 2017-18 will they make some changes in it so that chronic suffers can hope for some relief in future? Any other potential treatment in the pipeline for permenant suffers ?

 

[Johno]

Do you think AM 101 will be used for chronic/permenant tinnitus at all when it will be available in the future ? The trails are being done only for acute tinnitus and they say it will show no benefit on the chronic T. So if it's available in 2017-18 will they make some changes in it so that chronic suffers can hope for some relief in future? Any other potential treatment in the pipeline for permenant suffers ?

I dont see reason why AM101 will not be functional against chronic T, if it can repair overproduction of glutamic acid in damaged cochlea.

 

[Willie]

Mine is definitely noise induced so I'm pretty sure the cochlea is playing a part in this horrific noise in my head. Since am101 focuses on the cochlea, I don't see why it wouldn't help.

 

[Stina]

I understand why people are so hopeful about this drug, as it might be the first one to come. However, I would not be so positive about it. Thread the main thread about AM101 (has the most posts). There is a man there, under the name Resonance CEO, who works in a medical company and is a scientist. He seems to think that it will not work.
The point is that it has been researched that in time there are changes in certain parts of the tinnitus patients' brain. Therefore in time tinnitus will happen in your brain, not in the ear. The injection into the ear wont help then, because it wont reach the necessary part. What scientists dont know though, is where this changes exactly happen and why. I dont have time to post links now, but I know I have seen some articles about them and can do some researchagain later in the evening.
I see this as a positive thing, because if AM101 works this means scientists are even further away from finding a cure. AM101 only helps reduce the sound and surely wont work on everyone (no drug does). However, for permanent sufferers I myself see many treatments in progress - 1) Autifony, 2) Neuromodulation, 3) VNS, 4) MDMA. All of this are aimed at chronic sufferers. I think Autifony and VNS are starting Phase II this year. Of course maybe none of them will work, however, it seems promising. We are have threads about them here, read about them more. Trials take time though, so if we have smth in 5 years that would be very lucky.
As Am101 is targeted on the cochlea, I think it might work for noise- or infection-induced spikes, so that already good news.
I do not mean to bring you down, but as Hudson said - we should have guarded optimism. Science does not rely on belief but on rational data, and therefore it is probably more important to focus on the facts, and right now it is more the patients who think AM101 will work, not doctors. However, we have TRT available, which gives good results. Just continue living your life as well as possible, time will fly by and before you know it there will be smth for chronic suffererss too.

 

[Zimichael]

Stina...

Re what you said above: 1) Autifony, 2) Neuromodulation, 3) VNS, 4) MGMT.

I am finding links to 2) and 3) but searches of Autifony brings up a mixed bag of pretzels, and MGMT just brings up your post. Can you please elaborate on what those two refer to? (And I'm presuming Neuromodulation = the "Acoustic CR Nueromodulation"?).

Thanks much... Zimichael

 

[Stina]

Stina...

Re what you said above: 1) Autifony, 2) Neuromodulation, 3) VNS, 4) MGMT.

I am finding links to 2) and 3) but searches of Autifony brings up a mixed bag of pretzels, and MGMT just brings up your post. Can you please elaborate on what those two refer to? (And I'm presuming Neuromodulation = the "Acoustic CR Nueromodulation"?).

Thanks much... Zimichael

Autofny is this one here : 1) https://www.tinnitustalk.com/thread...-treatment-of-hearing-loss-and-tinnitus.1607/ and here http://www.autifony.com/autifony-science-publications.asp, MGMT dos not exist because its a band and what I meant was MDMA: https://www.tinnitustalk.com/thread...or-the-treatment-of-tinnitus.3885/#post-38985 Sorry about that!

 

[Grace]

Yeah my attitude towards am101 changed a bit since i first read about it... Im keepin my fingers crossed for vns and other treatments being soon tested, and even curious to see what mdma has to offer if any

 

[Raytr]

I really need some advice.pls help .... I will be evaluated from Am-101 study but I am not sure if I should go .My T is 1 1/2 month old and continuous