AM-101 TACTT1 Results Released

[StayPositive]

I was accepted into the trial and I'm scheduled for injections next week.

 

[cullenbohannon]

If AM 101 is proven to be effected someday . Will it work for noises in the head too?
Thank you @cullenbohannon

Hey rog I honestly have no idea if it will or not.

 

[nills]

I would like to clear the air regarding this comment. While you are indeed correct that AM-101 is a derivative of Ketamine (Esketamine, the S+ enatiomer of ketamine), I don't think the possibility of side effects is as great as you make it out to be. The novel thing about AM-101 isn't really the drug itself, but the drug and how it's used. AM-101 is delivered to the middle ear via an intratympanic puncture. The novelty of delivering the drug in this way is that you avoid systemic exposure of the active drug. Your inner ear gets exposed, and that's really about it. The AM-101 study documentation states that the amount of drug used is 1/1000th of a dose used for anesthesia. This fact is not trivial in their pursuit of minimizing side effects. You're much less likely to experience a side effect if the dose of a drug is extremely small and applied to a targeted region locally. That is why the adverse events reported by patients in previous AM-101 trials were vastly reported to be associated to the tympanopunction procedure itself, and not the activity of the drug.

That's my two cents though.

I would second this thought, Ketamine`s bad side effects are mainly kidney related which means it has to go through the bloodstream, and in huge amounts. Ketamine abusers usually have problems after extensive use (it`s fairly addictive substance because of the pleasurable experiences). Than again it is also know to reprogram neural links, which sounds like something that could be beneficial for the Tinnitus but this has of course no scientific backbone and again AM101 is in such small amounts and localized I doubt it will have this effect. I`m pretty sure it is super safe. The human body can handle quit a bit!

 

[cullenbohannon]

@Robb I think if am101 fails it won't be because it's not safe. Phase 1 and 2 proved that. Some drug trials fail 3 because of safety reasons but a very small percentage. In am101 the ketamine is not used in the traditional manner. The drug gets absorbed in the ear and the rest goes down the eustachian tubes. Only .81 mg are used for am101. for anesthesia they use much more I forget the exact number but it's something like 10 mg give or take. And they can administer multiple doses.

 

[James White]

It may also fail because my AM101 HTC smartphone isn't working correctly... i've contacted medpace, auris, the doctors... waiting for they reply but the doctors are lost with this device ...

 

[Valentin]

It may also fail because my AM101 HTC smartphone isn't working correctly... i've contacted medpace, auris, the doctors... waiting for they reply but the doctors are lost with this device ...

does it come with masking sounds?

 

[attheedgeofscience]

First I would like to thank @Dr. Nagler for his persistence in this thread by displaying objective info.
So my thoughts go sincerely to all AM-101 study participants and I encourage them to post a summary of their experience somewhere within the coming weeks. As I am confident we as community have brainpower to analyse some info.

I am so thankful to Dr. Nagler because it just sparked me to be more neutral instead of blindly euforic about a Trial 3
study which can fail say almost at coinflip chance.

Some input after reviewing AM-101 from a different side, my side:
We should all not forget that Ketamine is a substance of AM-101
http://en.wikipedia.org/wiki/Ketamine#Side_effects
As can be read about Ketamine is that this is how I call it a complex advanced substance which could cause complex side effects. The reason why there are treatment intervals is because pro longed exposure to ketamine is not advised.
Some thread participants wrongfully assume why medication is a no no. When having read the substance,
you don't want to have ketamine causing a negative reaction with a benzo.

The really good thing in terms of side effect which is overlooked is that AM-101 maybe has a strong tendence to protect hearing, this by partially having learned from auris substance AM-111 therefore being some kind of damage control substance?
http://www.aurismedical.com/p/news/news_11.php?lg=en


Off topic suggestion:
Furthermore, I think this thread shows some flaws of the interface which displays the forum @Markku it would be highly useful if the thread could display at all times at the final post which attachments have been added during posts.
This helping minimising time collecting the info.

Please allow the ability to further upgrade membership license, as we can opt for collecting money and decide as community how we spend the money. We could link the forum traffic link or transform traffic into crowd funding method.
Or invest this in an even better interface.
This because I am amazed about the brainpower which is gathered here.

@nills
@ResonanceCEO
@Hudson
@Johno
@seal
@David S
@Jacob_zjm
@makoda
@attheedgeofscience

Here's how to make a decision about any medical intervention: if the procedure is relatively safe and there is a chance it might work, then "give it a go". Especially in a phase III trial. And furthermore: clinical trials are usually free-of-charge. In my view, having the chance to get cured, without significant risks, and free-of-charge, what more could you ask for...?

Don't for one minute think that conventional medicine is necessarily safer than experimental medicine. Because it isn't...! I remember from my breakfast conversations with the CEO of the stem cell resource firm I met with while in Bangkok that, in the US, for basically every other hospitalization which ultimately results in the death of the patient, the Hospital will not willingly release the medical file to the family of the deceased (because some degree of error will have been made...). And that is with medicine based on established practices...! Think about that for a minute. Or two...!

(There are probably doctors out there who would prefer to keep a lid on the kind of information I have posted above, but if you know me then: I couldn't care less...)

 

[Jacob_zjm]

It may also fail because my AM101 HTC smartphone isn't working correctly... i've contacted medpace, auris, the doctors... waiting for they reply but the doctors are lost with this device ...

Hi James,

Look forward to any ongoing news and update about your condition,with best wishes for your recovery. For most of us here,whether it can help 'above 3-months' tinnitus' is the only meaningful am-101 topic to follow up.

 

[James White]

Hi James,

Look forward to any ongoing news and update about your condition,with best wishes for your recovery. For most of us here,whether it can help 'above 3-months' tinnitus' is the only meaningful am-101 topic to follow up.

Hi Jacob,

I'm now 2 weeks after the last injection. I'm exactly the same as i was before the injections. I think the gel has gone because i could hear my ear crackling a few days back. So nothing in particular to report

Thanks for asking,

 

[Johno]

Hi Jacob,

I'm now 2 weeks after the last injection. I'm exactly the same as i was before the injections. I think the gel has gone because i could hear my ear crackling a few days back. So nothing in particular to report

Thanks for asking,

 

[Bart Marien]

update: got my last injection 6 days ago. Ear is free again and the tinnitus volume is the same as before.
no decrease or change in my tinnitus. Starting to think i got the placebo.

 

[nills]

Fish was on the forum for quit a while after his injections and suddenly he left and came back with good news months after first injection. Think it works slower than we hope it does.

 

[lapidus]

Fish was on the forum for quit a while after his injections and suddenly he left and came back with good news months after first injection. Think it works slower than we hope it does.

Yes, and Fish only had one injection. I wonder what it would've been like if he didnt drop out.

 

[cullenbohannon]

I did not notice a change until close to a month after. 6 days is to soon to tell

update: got my last injection 6 days ago. Ear is free again and the tinnitus volume is the same as before.
no decrease or change in my tinnitus. Starting to think i got the placebo.

 

[DaveT]

I did not notice a change until close to a month after. 6 days is to soon to tell

how much of a change? has your tinnitus gotten quieter?

 

[cullenbohannon]

how much of a change? has your tinnitus gotten quieter?

Yits hard to say exactly but yes I've noticed a slight change. It's not as noticeable in my treated ear.

 

[Kathi]

Hey guys I am very aware of the difference of the volume of t going down vs habituating. I just know before I took things like lipos and thought it was going down. A couple weeks later I realized I hadn't changed at all. Many times people get nervous and think t has spiked when it's more perception. I just added that bit because it's hard to tell for sure but over the next few months I'm sure it will be more clear.

Best of luck cullenbohannon! I didn't realize you were in this trial. I truly hope you are healed and can move on in your life.

 

[Robb]

If the drug AM101 is administered, how will you be sure that the exact amount of eketamine is present?
I am sceptic because according to this article:
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3966923/
Someone died.

They say it is unrelated, but on such a fairly small sample base of 248 people with T i think it is fairly high!
Potential chance of:
1/248 = 0.4 %
Potential chance of serious non fatal side effect:
7/248= 2,8%

Comments are welcome..

 

[Johno]

If the drug AM101 is administered, how will you be sure that the exact amount of eketamine is present?
I am sceptic because according to this article:
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3966923/
Someone died.

They say it is unrelated, but on such a fairly small sample base of 248 people with T i think it is fairly high!
Potential chance of:
1/248 = 0.4 %
Potential chance of serious non fatal side effect:
7/248= 2,8%

Comments are welcome..

For quietness, calm ears and peace in my mind, worth it. For me for sure

 

[Robb]

For quietness, calm ears and peace in my mind, worth it. For me for sure

As always thanks for your answer. It is just that I would like to spark the community to further look at AM101

 

[t-man]

They say it is unrelated, but on such a fairly small sample base of 248 people with T i think it is fairly high!

Not really. No.

 

[StayPositive]

I received the first injection today. It was an uncomfortable experience but there wasn't a lot of pain. My ear feels full but no T spikes. Back tomorrow at 8 AM. Anxiety and fear still running a little high.

 

[cullenbohannon]

Hey Robb we briefly touched on this before but the person who died was in the placebo group so am101 could not have played a role. And we know how much am101 because they tell us they use. 81mg per injection

If the drug AM101 is administered, how will you be sure that the exact amount of eketamine is present?
I am sceptic because according to this article:
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3966923/
Someone died.

They say it is unrelated, but on such a fairly small sample base of 248 people with T i think it is fairly high!
Potential chance of:
1/248 = 0.4 %
Potential chance of serious non fatal side effect:
7/248= 2,8%

Comments are welcome..

 

[nills]

If the drug AM101 is administered, how will you be sure that the exact amount of eketamine is present?
I am sceptic because according to this article:
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3966923/
Someone died.

They say it is unrelated, but on such a fairly small sample base of 248 people with T i think it is fairly high!
Potential chance of:
1/248 = 0.4 %
Potential chance of serious non fatal side effect:
7/248= 2,8%

Comments are welcome..

As I said before, I am 100% sure that the fact they put esketamine in your ear will not make you fataly ill or kill you or cause any damage to your organs. Seriously, the body doesn`t work that way. I personally now people that sniffed copious amounts of ketamine and thank god even they are still okay.

 

[Stina]

@Robb if somebody had died the drug would not have made it to phase III. Thats why they have II phases for safety. Thats how easy it is. The scientists are not stupid and probably the death was not related to AM101

 

[JohnDoe]

I received the first injection today. It was an uncomfortable experience but there wasn't a lot of pain. My ear feels full but no T spikes. Back tomorrow at 8 AM. Anxiety and fear still running a little high.

Thank you for your feedback @StayPositive. It is highly appreciated!

I've read somewhere that when the injection is complete, you must refrain from swallowing for 30 minutes. Is this correct?

 

[Bart Marien]

Thank you for your feedback @StayPositive. It is highly appreciated!

I've read somewhere that when the injection is complete, you must refrain from swallowing for 30 minutes. Is this correct?

Correct. else the am101 might drain away too fast

 

[StayPositive]

Thank you for your feedback @StayPositive. It is highly appreciated!

I've read somewhere that when the injection is complete, you must refrain from swallowing for 30 minutes. Is this correct?

No problem. Yes it's true you are not supposed to swallow, but that was basically impossible for me. I tried my hardest not to but I still swallowed several times.

 

[StayPositive]

I received the second injection today. Overall the experience was better than the first. There was less pain and less fullness all around. Apparently there was a small amount of blood on the eardrum immediately after the injection, which is typical. Still no T spikes.

Back again tomorrow at 8 AM for the third and final injection.

 

[Champ]

I want some of this!