AM-101 Clinical Trial — Participants Updates and Discussion

[Atlantis]

Hi... is there anyone whose tinnitus went away completely and for good after the injections?

 

[AlexSongitus]

Hi... is there anyone whose tinnitus went away completely and for good after the injections?

We really need a results and progress thread for this similar to the Trobalt thread where we list:

-T level before AM-101
-time from onset to injections
-a progress report at 2 weeks, 30, days, 60 days and 90 days for round 1
-and more importantly the same thing for the open label round and any subsequent rounds.

As well as anything else you guys think should be included. One thing I notice is missing from the Trobalt thread is a place for people to their T level before treatment, so it's hard to keep track with member's progress when only the current T level is listed. You have to go back through the thread to see where their original post was.

 

[Alue]

The doctor said I won't get the real drug until years from now. I thought during the month- later visit you get the real thing.

I'm confused why they said this. There should be a followup study. Did you ask for an explanation?

We really need a results and progress thread for this similar to the Trobalt thread where we list:

-T level before AM-101
-time from onset to injections
-a progress report at 2 weeks, 30, days, 60 days and 90 days for round 1
-and more importantly the same thing for the open label round and any subsequent rounds.

As well as anything else you guys think should be included. One thing I notice is missing from the Trobalt thread is a place for people to their T level before treatment, so it's hard to keep track with member's progress when only the current T level is listed. You have to go back through the thread to see where their original post was.

A more complete report should be available some time in 2016 when Auris releases their results.

 

[Hotaru]

You are supposed to be offered to participate in the open label follow-up study after 90 days where you do get to take the real AM-101. And you can have multiple rounds, I believe, it's up to 3. Your last follow-up visit of AM-101 is supposed to be the first day of injections of the open label round.

Not sure if its different where you are or what. Strange.

This is what I don't get, though. From what I've read on this forum, I thought after a month of getting the injections, they told you if you got the placebo or not, then you'd set up to get the real drug immediately after. I did not know this would be a 90 day process. I have to travel 5 hours up and back by car to get to this place. I can't keep doing that.

And after 90 days, wouldn't getting the real drug be pointless? I thought this only worked on ACUTE tinnitus. Why not just wait for the drug to come out on the market? Would they accept me then if I still have T, since it only works on acute tinnitus?

 

[Alue]

This is what I don't get, though. From what I've read on this forum, I thought after a month of getting the injections, they told you if you got the placebo or not, then you'd set up to get the real drug immediately after. I did not know this would be a 90 day process. I have to travel 5 hours up and back by car to get to this place. I can't keep doing that.

And after 90 days, wouldn't getting the real drug be pointless? I thought this only worked on ACUTE tinnitus. Why not just wait for the drug to come out on the market? Would they accept me then if I still have T, since it only works on acute tinnitus?

That's correct, it's 90 days, and you don't get to know if you got the placebo or not.

90 days does seem it puts you at the tail end of effectiveness assuming you are already 2 to 3 months into tinnitus, but some people here have seen benefits 8 months out.

Ideally we could all get the real drug within 2 weeks of our onset, but this is the best chance we have to fight it in the early stages. There is nothing else.

 

[AlexSongitus]

This is what I don't get, though. From what I've read on this forum, I thought after a month of getting the injections, they told you if you got the placebo or not, then you'd set up to get the real drug immediately after. I did not know this would be a 90 day process. I have to travel 5 hours up and back by car to get to this place. I can't keep doing that.

And after 90 days, wouldn't getting the real drug be pointless? I thought this only worked on ACUTE tinnitus. Why not just wait for the drug to come out on the market? Would they accept me then if I still have T, since it only works on acute tinnitus?

I was told they can't tell you period, because they don't know. Not even after 90 days. You take part in the 2nd round without ever knowing if you got the placebo or not. It's a 90 day process but I think there are only 2 other follow up visits and then the last one.

There are not many places in the US offering this service. Some people had to fly to have their injections. So it depends on how important it is for you.

As far as effectiveness, it depends if you get lucky and get the real thing the first time, but I was told a couple of people chose to follow through and do all 3 rounds because they believed it helped. So that's quite late for those that did. That's why I say it's good if we were able to have a progress thread to track it.

 

[Alue]

I was told they can't tell you period, because they don't know. Not even after 90 days. You take part in the 2nd round without ever knowing if you got the placebo or not. It's a 90 day process but I think there are only 2 other follow up visits and then the last one.

There are not many places in the US offering this service. Some people had to fly to have their injections. So it depends on how important it is for you.

What do you mean there are not many places in the US offering this service? Are you talking about the trial all together or the followup? I thought the followup and open label was built into the trial.

 

[AlexSongitus]

What do you mean there are not many places in the US offering this service? Are you talking about the trial all together or the followup? I thought the followup and open label was built into the trial.

I was talking about both.

 

[TC426]

You are supposed to be offered to participate in the open label follow-up study after 90 days where you do get to take the real AM-101. And you can have multiple rounds, I believe, it's up to 3. Your last follow-up visit of AM-101 is supposed to be the first day of injections of the open label round.

I second that. As a participant of phase III, you are entitled to the real drug as a "goodie" for participating after 90 days. I tried to find out whether new injections may be postponed for a certain period after the 90d checkup, but did not receive any clonclusive answer, so I assume that not.

From what I've read on this forum, I thought after a month of getting the injections, they told you if you got the placebo or not, then you'd set up to get the real drug immediately after. I did not know this would be a 90 day process.

That's correct, it's 90 days, and you don't get to know if you got the placebo or not.

I am not sure how the framework is in the US. For the trial elsewhere you will get to know whether you got the placebo or the real stuff eventually, however, that will not be before the final results of phase III have been published (so way down the road, probably Q3/16 or even Q4/16).

This has bugged me a little too, as knowing it might influence my decision on participating in the next round...

 

[Alue]

I was talking about both.

So are you saying some people go through the double blind round without ever being given the opportunity to do the open label round? I have never heard of that for this trial.

 

[AlexSongitus]

So are you saying some people go through the double blind round without ever being given the opportunity to do the open label round? I have never heard of that for this trial.

No I think you misunderstood. All I was saying is that the trial + 2nd study is not offered everywhere. It's at a few locations in the USA.

 

[OddV]

No I think you misunderstood. All I was saying is that the trial + 2nd study is not offered everywhere. It's at a few locations in the USA.

This is true, I had to push my site to get certified for the 2nd study. It happened for them the day I started.

 

[Alue]

No I think you misunderstood. All I was saying is that the trial + 2nd study is not offered everywhere. It's at a few locations in the USA.

This is true, I had to push my site to get certified for the 2nd study. It happened for them the day I started.

Did they tell you outright that you would be offered the 2nd study? I'm just confused why people would go through the double blind and not be offered the 2nd study? That seems kind of crappy.

Does the sponsor authorize the second study separately? You said you had to push your site to get certified for the 2nd study. I would think if they were certified to conduct the double blind they would be certified to conduct the open label study.

 

[AlexSongitus]

Did they tell you outright that you would be offered the 2nd study? I'm just confused why people would go through the double blind and not be offered the 2nd study? That seems kind of crappy.

Does the sponsor authorize the second study separately? You said you had to push your site to get certified for the 2nd study. I would think if they were certified to conduct the double blind they would be certified to conduct the open label study.

That's what I was wondering about as well when @Hotaru mentioned that. Yeah, in my case, I had to ask, they didn't volunteer it and it's not mentioned in the AM-101 trial paperwork either. They talked to me about it and told me if I decide to do it the last follow-up for this trial will be the first days of injections for the next. It's a separate study that tests safety of the number of times the treatment can be performed and side effects. Maybe they would have offered it when I actually do the injections, but I don't think they would have said anything at the screening without me asking.

 

[Sebastians]

Had my last shot of round one. Only had my left ear done, as my right is currently 1/10 and i did not want to take the risk.
First two shots went really well. Minor pain and fullness that went away after a night's sleep. The last one today was rather unpleasant, due to a different doc. An older, rather brutish woman that seemed not so concerned. So,it was the most painful injection. I do hope she didn't make things worse though, as i was rather optimistic until today.
The first doc was really gentle and put me at ease. Sucks he wasn't there.
T much louder now, and fullness. Not uncommon, but i do hope it will pass quickly. Probably due to a the new hole in the eardrum.
Will keep you people posted on any news, good or bad.

 

[Hotaru]

That's what I was wondering about as well when @Hotaru mentioned that. Yeah, in my case, I had to ask, they didn't volunteer it and it's not mentioned in the AM-101 trial paperwork either. They talked to me about it and told me if I decide to do it the last follow-up for this trial will be the first days of injections for the next. It's a separate study that tests safety of the number of times the treatment can be performed and side effects. Maybe they would have offered it when I actually do the injections, but I don't think they would have said anything at the screening without me asking.

I just asked them by email and they said they do offer it after the trial is complete.

 

[AlexSongitus]

I just asked them by email and they said they do offer it after the trial is complete.

Good to hear. There you go. You have to ask at some centers.

 

[makocc21]

Hello, I am new to this and don't know I am doing this right. I have been invited to the AM 101 trails and have not seen much on the pre screening for the ttial. Can I be disquaify for high blood pressure or for taking Losartan for blood pressure? What are some of the disquaifiers during the pre screen?

 

[Joe Bananas]

Hope this is not too off topic: I have been making some numbers and have realized I will receive the open label round around my 7 month mark since onset. May I hope any relief at that point?
I also want to ask about my T behaviour. It seems to react to surrounding sounds. As I am at bed or in any quiet environment it seems to go quieter (I say it seems since for me this could be a real subjective perception). If I go to any place where sounds go louder than the 30dbs average I have in my room when night time I can still hearing it being those dbs 40, 50, 60 and even 70. Reaching 80dbs it gets somewhat masked. Funny thing is shower does the trick and masks it completely. Why is this happening? Is some sort of hyperacusis and can I expect it to resolve by itself? I am almost in my 5 month mark since onset. What could I expect?

 

[Mithrandir]

@Joe Bananas

My reactive T is soften since my ENT gives me AED

 

[Joe Bananas]

@Joe Bananas

My reactive T is soften since my ENT gives me AED

Please tell me what's AED. And, does reactive tinnitus get solved by itself with time? It sucks to hear it everywhere. Is reactive tinnitus any form of T + Hyperacusis cocktail?

 

[Sebastians]

@Joe Bananas
So the first injections gave you no relief whatsoever?
How long did it take for the post-injection spike to subside?

I don't think you have full-blown H, the reactivity will hopefully mellow down as time progresses. A lot of people's T seems to settle down somewhat after 6-8 months

 

[medal]

Hope this is not too off topic: I have been making some numbers and have realized I will receive the open label round around my 7 month mark since onset. May I hope any relief at that point?
I also want to ask about my T behaviour. It seems to react to surrounding sounds. As I am at bed or in any quiet environment it seems to go quieter (I say it seems since for me this could be a real subjective perception). If I go to any place where sounds go louder than the 30dbs average I have in my room when night time I can still hearing it being those dbs 40, 50, 60 and even 70. Reaching 80dbs it gets somewhat masked. Funny thing is shower does the trick and masks it completely. Why is this happening? Is some sort of hyperacusis and can I expect it to resolve by itself? I am almost in my 5 month mark since onset. What could I expect?

I haven't posted anything in this thread yet, although I follow any info on the am 101 trial. I'm able to participate in the AM-101 trial but not sure if I should go for it. Regarding the above quote, i'm having exactly the same reactive tinnitus issue. It's the hardest to cope with and I've literally no clue how reactive tinnitus works. I was thinking maybe the s-ketamine could work on this symptom but seeing your comment you actually got reactive tinnitus after the procedure was done?

Can someone kind of explain the mechanisms of reactive tinnitus?Does it mean some of the inner hairs are still left, so the neurons move with the beat so to say when the frequency is heard? To many questions, hopefully it settles down...

 

[Joe Bananas]

@Joe Bananas
So the first injections gave you no relief whatsoever?
How long did it take for the post-injection spike to subside?
A lot of people's T seems to settle down somewhat after 6-8 months

I can't call relief what I experienced after that first round. Actually my T is more fluctuating since then and when it reach its quieter spot I consider it to be quieter than pre-shots but really, my mood, perception, awareness, etc... is all a real mess now and I don't feel I am able to be accurately objective in those terms.
As for the spike; As I mentioned I am experiencing what is known and called reactive T since the very first day of onset so, as my ears were "clogged" by the substance (placebo/AM101) I perceived a really quiet T those days, so no spike.

It's the hardest to cope with and I've literally no clue how reactive tinnitus works. I was thinking maybe the s-ketamine could work on this symptom but seeing your comment you actually got reactive tinnitus after the procedure was done?

Can someone kind of explain the mechanisms of reactive tinnitus?Does it mean some of the inner hairs are still left, so the neurons move with the beat so to say when the frequency is heard? To many questions, hopefully it settles down...

Never experienced anything but reactive T since onset so I can't tell you if this form of TorTure is easier or more difficult to cope with than steady T. Anyhow for me it is being a hell of a problem to get adapted to this crap.
Again, shots haven't give me reactiveness, that shit came in the same pack as my T did from day one. I am also really interested in all those questions regarding reactive T.

 

[AlexSongitus]

Hello, I am new to this and don't know I am doing this right. I have been invited to the AM 101 trails and have not seen much on the pre screening for the ttial. Can I be disquaify for high blood pressure or for taking Losartan for blood pressure? What are some of the disquaifiers during the pre screen?

This is one of the lists I found:
Exclusion Criteria:

• Tinnitus that is not completely maskable
• Fluctuating tinnitus
• Intermittent tinnitus
• Meniere's Disease
• Acute or chronic otitis media or otitis externa
• Any ongoing therapy known as potentially tinnitus-inducing (e.g. aminoglycosides, cisplatin, loop diuretics, high doses of aspirin, quinine etc.)
• Any drug-based therapy for inner ear hearing loss that is ongoing or was performed in the past 2 weeks, e.g. prednisolone, dexamethasone, pentoxifylline, betahistine, diazepam, carbamazepine, sodium valproate and antidepressants
• Concomitant use of any other NMDA receptor antagonist (e.g. memantine, dextromethorphan, ifenprodil)
• Any ongoing or planned concomitant medication for the treatment of tinnitus until 90 days after study drug application
• History or presence of drug abuse or alcoholism
• Any clinically relevant respiratory, cardiovascular, neurological (except vertigo), or psychiatric disorder
• Known hypersensitivity, allergy or intolerance to the study medication or any history of severe abnormal drug reaction
• Women who are breast-feeding, pregnant or who plan a pregnancy during the trial
• Women of childbearing potential who declare being unwilling or unable to practice contraception such as hormonal contraceptives, sexual abstinence or intercourse with a vasectomised partner
• Concurrent participation in another clinical trial with an investigational drug or participation in another clinical trial with an investigational drug within 30 days prior to study entry
• Any drug-based therapy for otitis media that is ongoing or was performed in the past 2 weeks

Also depression. Don't self diagnose yourself as depressed. Fluctuating refers more to intermittent I believe, because they seem to be pretty flexible on that one. They are ending accepting new participants this month across the US. So if you want to get in, you have a week or two at most, maybe days. Act fast.

 

[AlexSongitus]

Hope this is not too off topic: I have been making some numbers and have realized I will receive the open label round around my 7 month mark since onset. May I hope any relief at that point?
I also want to ask about my T behaviour. It seems to react to surrounding sounds. As I am at bed or in any quiet environment it seems to go quieter (I say it seems since for me this could be a real subjective perception). If I go to any place where sounds go louder than the 30dbs average I have in my room when night time I can still hearing it being those dbs 40, 50, 60 and even 70. Reaching 80dbs it gets somewhat masked. Funny thing is shower does the trick and masks it completely. Why is this happening? Is some sort of hyperacusis and can I expect it to resolve by itself? I am almost in my 5 month mark since onset. What could I expect?

The only way to answer that question is really to have someone that took part in the open label round that late and experienced improvement. I was told that some people in my study tried multiple rounds so they would have gone past that time frame, but the girl did not say they saw improvement. It's really tough to say. Perhaps your T is still fluctuating right now and I hope it settles down over the next couple of weeks. How long as it been since your injections now?

 

[liquefact]

I also want to ask about my T behaviour. It seems to react to surrounding sounds. As I am at bed or in any quiet environment it seems to go quieter (I say it seems since for me this could be a real subjective perception). If I go to any place where sounds go louder than the 30dbs average I have in my room when night time I can still hearing it being those dbs 40, 50, 60 and even 70.

This is exactly what i experienced and which freaked me out in the beginning. I was masking in the first month while trying to sleep but one day i noticed that the more i masked louder the T. I just felt very afraid as i realized that i had to listen to this shit and there's no way out. This is perfectly normal. Your brain still tries to concentrate on this sound and it's slowly becoming a non-alien sound that needs to be heard. It'll give up eventually and your T shall fade in background. Do not fight, do not obsess, just do not care. Spending too much time here will not help either. It has it's own mindset but after somepoint you will not need to actively do anything to ignore it. It'll just be like this, do not worry.

 

[Dutchy]

I find that hard to believe that you got in the trial legitimately. The exclusion criteria from Auris Medical is as follows:

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.

Either you got in by lying or it was some oversight from the trial site. Either way you got the injections. You do not have to justify your actions to random disgruntled internet people.

I'm just wondering,how can they be sure about 1/4 being exclusion criteria?how did they concluded this
is most beneficial to early onset?.If there's a compound present that helps with T they surely had to have some brain plasticity in mind as well.It just doesn't make a whole lot of sense to me.

 

[Bobby B]

They did tests on animals there is a link to papers posted by ATEOS

After some time effectiveness decreased in animals , also the best results were the ones wiht loud t vs mild ones in animals

 

[Nucleo]

I'm just wondering,how can they be sure about 1/4 being exclusion criteria?how did they concluded this
is most beneficial to early onset?.If there's a compound present that helps with T they surely had to have some brain plasticity in mind as well.It just doesn't make a whole lot of sense to me.

Their compound tries to stop damage in the inner ear as it is still occuring weeks after the incident. This helps hearing function recover and lessens the symptons.

AM-101 is not thought to have any effect at the CNS level, thus chronic tinnitus, which is thought to occur at this level, is excluded.