AM-101 TACTT1 Results Released

[Robb]

I'm unsure what you mean. Is this your summary of what the guys at the hospital told you (re the +3 months) when you went for your 4th injection?

Steve it is my summary. If you would like to comment on it with your thoughts you are welcome please do

I wrote that post since I didn't like the fact that a member posts that AM-101 will possibly have no effect at all for T sufferers over 3 months. This means that I would have been dumb (maybe even mislead) by taking a shot today.

 

[SteveToHeal]

Steve it is my summary. If you would like to comment on it with your thoughts you are welcome please do

I wrote that post since I didn't like the fact that a member posts that AM-101 will possibly have no effect at all for T sufferers over 3 months. This means that I would have been dumb (maybe even mislead) by taking a shot today.

I just wanted to get the facts before commenting. I've seen how discussions on here get heated with the wrong info.

So just to clarify, is it the hospital staff (research scientist + ENT who administered the drug/injection) who told you that AM101 is potentially helpful against T past the 3 month mark?

If I remember correctly, there was a post from the member you referred to that said he had been told some "inside info" from someone at Auris that it was most effective in the first week and diminishing in effectiveness up to 2.5 months. So if I have to hazard a guess, a drill down into the results of phase 2. He said he would confirm his source with the TT moderator.

 

[Rube]

@earsnothappy

Quite frankly my ENT isn't giving me any more information than what I already know. In fact it seems like I know more than he does when it comes to AM-101 since I've been reading anecdotal reports from users like yourself on this forum. I am also on this trip alone since I am a student far away from home, all my buddies here are busy with their own classes and work, can't possibly ask them to drop what they're doing so they can baby me for 4 days out of nowhere. Did you have any dizziness or vertigo following the procedure? Cause I would like to drive back home (2-hour drive) on the same day so I can attend class later that evening.

@CathodeRaySound - have you decided to go through with the injections?

 

[Robb]

I just wanted to get the facts before commenting. I've seen how discussions on here get heated with the wrong info.

So just to clarify, is it the hospital staff (research scientist + ENT who administered the drug/injection) who told you that AM101 is potentially helpful against T past the 3 month mark?

If I remember correctly, there was a post from the member you referred to that said he had been told some "inside info" from someone at Auris that it was most effective in the first week and diminishing in effectiveness up to 2.5 months. So if I have to hazard a guess, a drill down into the results of phase 2. He said he would confirm his source with the TT moderator.

I would be interested if that post of him indeed would be confirmed with the moderator at TT.
Confirming a source is easy, but to confirm it by delivering a written statement huh?

@Hudson
@Markku

 

[SteveToHeal]

I would be interested if that post of him indeed would be confirmed with the moderator at TT.
Confirming a source is easy, but to confirm it by delivering a written statement huh?

@Hudson
@Markku

I would also like the source confirmed and if you look back on the thread you will see i asked him that question. Moderators, if you can please respond. Thanks.

 

[SteveToHeal]

I would be interested if that post of him indeed would be confirmed with the moderator at TT.
Confirming a source is easy, but to confirm it by delivering a written statement huh?

@Hudson
@Markku

Robb can you also answer this:

So just to clarify, is it the hospital staff (research scientist + ENT who administered the drug/injection) who told you that AM101 is potentially helpful against T past the 3 month mark?

Thanks

 

[Robb]

Robb can you also answer this:

So just to clarify, is it the hospital staff (research scientist + ENT who administered the drug/injection) who told you that AM101 is potentially helpful against T past the 3 month mark?

Thanks

I called with Auris (name of person not asked, remembered) they told that they don't know if AM-101 will be successfull over 3 months. But they said it would be a waste to assume not as the data of first tests showed there was no interruption of efficacy towards the 3th month interval. Of course can we debate in how far AM-101 is effective, this has to be decided by Jury who will see if they release the drug.

Happy?

 

[SteveToHeal]

I called with Auris (name of person not asked, remembered) they told that they don't know if AM-101 will be successfull over 3 months. But they said it would be a waste to assume not as the data of first tests showed there was no interruption of efficacy towards the 3th month interval. Of course can we debate in how far AM-101 is effective, this has to be decided by Jury who will see if they release the drug.

Happy?

Thanks. That does oppose what was said in the post we have been discussing. It's strange to understand why insider in question would have given misinformation?? We'll have to wait and see what the results of TACTT3 are to be sure. Thanks for sharing this info. It is re-assuring for those +3 monthers, if indeed this new info is true, re no interruption of efficacy towards the 3th month interval. It's difficult who to believe.

 

[earsnothappy]

In the trial area that I'm taking part in, I was told that at least one patient in the post 3 month follow up trial has had really good results.

 

[earsnothappy]

You say you are not sure if your vertigo resulted from the injections. Did you suffer from vertigo before?

The first 2 episodes of vertigo I'm fairly certain were caused by the injections. The episode that was about 2 weeks after my injections is the episode that I can't attribute to the injections. I've never had vertigo before, but being so many days after the injections, I may have just slept weird or something. I don't know. My sleeping pattern ever since my tinnitus began hasn't been very consistent. I did tell the trail coordinator and the doctor about that vertigo episode, and it is being reported back to the trial sponsors, though I can't say for certain it was caused by the injections.

 

[Marius T]

Hi this is my first appearance on this site i've had tinnitus for about 2weeks and a half due to loud noise exposure. I took the best pills i could but I can still permanently a whistle noise in my 2 ears. I'm only 17 and french, i can travel to get the trial of the AM 101, but I want to know if they were cases of negatives effects (temporary or not) before i give it a shot. I know i'm in the first phase of tinnitus but from what i read here for the past two days i think I should consider a chance like that. Help me please !

 

[Marius T]

BTW I'm not 18, is that a problem ? I'm hopeful anyway and have passed the depression time since i got a friend who got T for 1 year now who really helps me, but I think i have to get all the chances to get rid of this shit

 

[attheedgeofscience]

Hi this is my first appearance on this site i've had tinnitus for about 2weeks and a half due to loud noise exposure. I took the best pills i could but I can still permanently a whistle noise in my 2 ears. I'm only 17 and french, i can travel to get the trial of the AM 101, but I want to know if they were cases of negatives effects (temporary or not) before i give it a shot. I know i'm in the first phase of tinnitus but from what i read here for the past two days i think I should consider a chance like that. Help me please !

Here you go: http://www.tinnitus-study.info/fr-home

I believe you need to be 18 years of age, however. But, I am aware that there were test subjects in the phase II trial who were only 16 years old. I suggest you contact one of the clinical trial centres.

Read this site for testimonials on the effects. Yes, there are negative effects with the medication - as with any medication (incl. the "pills" you recently took...).

 

[Marius T]

Thanks a lot but i've read that those sides effects were only temporary, do you know about that (thank you again)

 

[attheedgeofscience]

Thanks a lot but i've read that those sides effects were only temporary, do you know about that (thank you again)

There are +1500 posts in this thread alone. Read through (some of) it, and all your questions will be answered.

Yes, it is safe.

 

[Marius T]

I can't thank you enough, i'll post when i will know if i can or not participate to the trials

 

[SteveToHeal]

I can't thank you enough, i'll post when i will know if i can or not participate to the trials

And a word of advice if you are serious about taking part and getting ON the trial. A lot of people here assumed that they would "just get on" and said some things in the interview that DQ'd them. It's not that easy to get on. There are very strict eligibility criteria. Read this thread thoroughly as ATEOS suggested and search for the eligibility criteria specifically. Make sure you meet those criteria BEFORE applying. One guy here told them his T went up after running and they DQ'd him. So use your common sense. If you want to get through, tell them that your T is constant or "constant enough" for them to have a baseline. That for example is one of the criteria. There are lots of others. So go read and do the research. Remember, they don't care either way if you get on or not. They are in the business of recruiting good test subjects. Keep that in mind when applying. So go into "job interview" mode if you like. I feel a lot of guys have been really lackadaisical in their approach to get on the trial and they have been DQ'd as a result of it.

It is not a given that you will be accepted just because you have T. I don't think people here realise how lucky they are to have this opportunity to get on it. It's the first time in history that people potentially have a drug to take T away, ESPECIALLY if you have T in the early stages (and possibly even for later stages... results unknown as of yet from the TACTT3). If I was them, I would make 100% sure I met all the criteria beforehand and answer correctly to not get DQ'd. You only get one shot at this. You can't take it back if you answered incorrectly the first time round and say you meant to say something else. Once you are DQ'd, that's it. AM101 is unacessible to you and you're in the pit with the rest of us. So make sure! This is not a post to scare the hell out of you but if you are serious, you should do your homework around the criteria and make sure you know what they want to hear.

 

[Marius T]

Thank you Steve, i'm gonna work on this, but do you advise me to lie if necessary ?

 

[Marius T]

from what i've seen here on clinicaltrials com , i fit in excluding the fact that i'm not 18 yet.

 

[Marius T]

Also, this is not the subject but i smoke weed quite often, should i stop to fit with the trials, before the trials or now ?

 

[SteveToHeal]

Also, this is not the subject but i smoke weed quite often, should i stop to fit with the trials, before the trials or now ?

LOL. Yes. Most definitely. They take bloods and they'll DQ you for any drugs in your system. Check how long dope takes to come out of your system. I think its a couple of weeks.

 

[Marius T]

oh shit you are sure about that ? they do urinal tests too or only blood ?

 

[Marius T]

for blood it's up to 2 weeks, and a bit more for urinal tests, but no problem for that i can stop from a day to another, it's a great occasion in fact.

 

[SteveToHeal]

Thank you Steve, i'm gonna work on this, but do you advise me to lie if necessary ?

No. Don't lie. But if they ask you a question like "Does your T vary in loudness?" don't say "Yes", because you know it does only when you run", otherwise, they'll DQ you. Most T sufferers, T goes up when they exercise. More blood to the ears. Nills explains it in the thread somewhere. But don't tell them that, otherwise you won't get through. This is not lying. It's just omitting irrelevant data. You could argue that Auris should know that T goes up when people exercise but they don't care about that. They don't have time to monitor participants daily exercise routines for irregularities to know when or when not to dismiss data, under what conditions etc. The question is "Is your T constant?" If it is constant (except that it goes up when you exercise) then say Yes. Follow?

To them, it's hard data. If you tell them your T varies, you're out. They don't care its because when you exercise. All they are concerned about, is can they use you as a participant with a constant base line to reference before and after T loudness and annoyance. They don't care how you keep your T constant, just as long as you do. I can say that my T is pretty constant. Sure it goes up directly after exercise but i would know to use my pre-exercise T loudness as a baseline when comparing my T before and after the injections. I wouldn't use my T loudness just after a run. That is transient. Make sense?

Another example is stress. My T goes up when i'm stressed. But i'm not going to use my post-stress "more adrenalin" as a base line am I? No, of course not. That would be silly.

So don't lie. Just think strategically. What saddens me is guys are getting DQ'd because they haven't. By that stage it will be too late and you'll be crying over spilt milk in the T pit with the rest of us mofos. Just remember Auris NEED a constant base line. Use your common sense and know what it is they want to hear. i.e. Don't tell them something insignificant like stress or exercise related T, that they can DQ you on. You are only doing yourself a disservice and ruining your one chance to get on the trial. So treat it like an interview is all i'm saying. No need to tell them your life story. Too much information is more info they can DQ you on. They aren't the enemy but they are a company after all, looking to make money. Hope this helps.

 

[SteveToHeal]

oh shit you are sure about that ? they do urinal tests too or only blood ?

both

 

[Marius T]

ok well, and what other things shouldn't i say to get in the tests ? except the fact that it's constant (that's true anyway) I don't know what else to think about

 

[Marius T]

another question, is smoking tobacco okay or i should stop too, it'd be hard but i can

 

[CathodeRaySound]

Unfortunately I was rejected at the last minute, this incompetent doctor asked me at the last moment if I came with somebody to drive me home, and I said no, because the agreement was I will be staying at the hotel and using cab rides for the time being...so he said, "I'm not giving you any injections, and that's that." It's quite irritating because 2 weeks ago at the preliminary exam the deal we agreed on was I get a hotel room nearby and I was to take the cab to the hospital for the duration of my treatment, it was disheartening to be rejected after 2 weeks of hope, and then after a 2 hour drive today for my first injection this doctor completely changes the initial agreement and also told me, "I never agreed for you to stay at a hotel and use the cab for transportation". When I called the Auris Medical office and told them what happened, even they were dumbfounded by the doctor's decision. Well, there goes my opportunity for a potential cure at the acute stage...I can't believe it.

The worst part was, I told him I can probably arrange for my friend to come as a care giver immediately, so I will try giving a phone call before he makes the final decision to reject me, he basically said, "I don't think so, I already made my mind."

 

[Robb]

Unfortunately I was rejected at the last minute, this incompetent doctor asked me at the last moment if I came with somebody to drive me home, and I said no, because the agreement was I will be staying at the hotel and using cab rides for the time being...so he said, "I'm not giving you any injections, and that's that." It's quite irritating because 2 weeks ago at the preliminary exam the deal we agreed on was I get a hotel room nearby and I was to take the cab to the hospital for the duration of my treatment, it was disheartening to be rejected after 2 weeks of hope, and then after a 2 hour drive today for my first injection this doctor completely changes the initial agreement and also told me, "I never agreed for you to stay at a hotel and use the cab for transportation". When I called the Auris Medical office and told them what happened, even they were dumbfounded by the doctor's decision. Well, there goes my opportunity for a potential cure at the acute stage...I can't believe it.

The worst part was, I told him I can probably arrange for my friend to come as a care giver immediately, so I will try giving a phone call before he makes the final decision to reject me, he basically said, "I don't think so, I already made my mind."

I feel sorry for you, the only thing I can tell you is that any ENT who performs T treatment should have 7 days long headphones on except when sleeping to experience what it is like to not escape a sound.

Don't give up you still have a lot to gain , lose

 

[CathodeRaySound]

I feel sorry for you, the only thing I can tell you is that any ENT who performs T treatment should have 7 days long headphones on except when sleeping to experience what it is like to not escape a sound.

Don't give up you still have a lot to gain , lose

Thanks for the encouragement, I'm just shocked because the last time we spoke at the preliminary exam he made it seem like the whole "you shouldn't drive" thing was a mere recommendation and not a requirement. I even told him, I probably won't have a driver with me, and he was nonchalant about it. Now he turns it into a big issue, which I don't understand because if it's such a serious issue why can't I just stay at the hotel and use the cab as planned? Oh well...like you said, many ENT docs won't understand the severity of the whole tinnitus issue until they go through it themselves. For me it was a chance of possibly curing a serious problem, for him it's something I should just "stop worrying about."