AM-101 Clinical Trial — Participants Updates and Discussion

[JohnK]

Some other notes after re-reading the thread:

-For numbing me, they basically poured lidocaine into my ear canal and drained it 25 mins later
-I haven't had any leakage onto my pillow or anything else.
-I haven't tasted anything or felt anything going from my ears to my throat.

 

[OddV]

Whoops!

Yep, guess they blew their enrollment #'s. I was the only one at my site from Oct 2014 - July 2015. I've touched based with the trial nurse a few times and they still haven't had anyone else.

 

[Jahhsoul]

Guys I have a "problem" with this study, need recomendation:

-My T is idiopathic, but I received hard ATM and neck treatment and my T is exactly the same. I got a "false" medical document which said that the cause of my T was Otitis Media (I Had a slightly painful infection in my right ear two weeks before my T) so I could be accepted on the trial.

-I said to the doctor two weeks ago: "I think that I only have T in the infected ear".But after hard checkings I realized that my tinnitus is bilateral. So my question:

¿Do you think I can say to my doctor that I want the injections in both ears? Maybe he says: "If you have T in both ears, then the cause was not the Otitis Media, so you cannot take part on this study".

My other option is get the injections in my right ear, and in the open-label trial ask him to treat my both ears, so at least I get the first round in my right ear for sure xD

Help please!

 

[Nucleo]

I wonder if he considers "long-term" to be 5 years or 50....

5 years definitely isn't considered ''long term'' in the medical research world.

 

[Nucleo]

¿Do you think I can say to my doctor that I want the injections in both ears? Maybe he says: "If you have T in both ears, then the cause was not the Otitis Media, so you cannot take part on this study".

I do not think you can tell the ethiology of tinnitus by the laterality of the symptoms. It was most likely the infection.

 

[Jahhsoul]

@Nucleo You mean I should tell my Doctor that I have bilateral T, true? Hope he still let me participate on the trial

Thanks!

 

[Jeffrey F]

Thanks @Jeffrey F !

Was your T spike instantaneous or did it happen a bit later?

So my spike happened like this. Inserted injections and no spike. As I held my head to the side and let the injection sink in, over thirty minutes spike began to set in and got to max volume 15 minutes after injection. Then stayed super loud for three hours. After that it began to settle down a bit. Im now two days from my injection and its still pretty loud unfortunately. But my tinnitus was pretty loud when I got the injection. It was a 6 before I got the injection and a 6.5 now

 

[spime]

Just a quick update for my part. Just got back from Escondido,CA site for AM-101 screening. I got this HTC phone they want me to complete surveys daily. My injections are set for next 1/25 -Monday, tuesday, wednesday.

As for getting the injections, all the info and experiences here are great. My personal insurance doctors are against me getting these injections. But then again this is a personal decision but I am worried my insurance won't cover the damages that MAY(but not likely) occur from these injections.

Facts from my branch, they had 3 participants out of 20? or so had their tinnitus completely go away.

 

[attheedgeofscience]

My personal insurance doctors are against me getting these injections.

I wonder if the same doctors are also against you visiting a hospital - any hospital - in the future. To the unknowing reader - of the which there are plenty on this board - here is a simple snapshot of what can go wrong the next time you set your foot in a hospital:

www.webmd.com/a-to-z-guides/features/before-surgery-your-top-six-hospital-risks

Folks die every year from:

• complications of surgery
• wrong medication
• infections acquired during the stay in the hospital (no less)!

Have your pick - and mind you, most of the above cases could have been prevented! Medicine is far from perfect. Of course, your local physician - with his/her infinite wisdom - would like you to believe otherwise.

 

[linearb]

I wonder if the same doctors are also against you visiting a hospital - any hospital - in the future. To the unknowing reader - of the which there are plenty on this board - here is a simple snapshot of what can go wrong the next time you set your foot in a hospital:

www.webmd.com/a-to-z-guides/features/before-surgery-your-top-six-hospital-risks

Folks die every year from:

• complications of surgery
• wrong medication
• infections acquired during the stay in the hospital (no less)!

Have your pick - and mind you, most of the above cases could have been prevented! Medicine is far from perfect. Of course, your local physician - with his/her infinite wisdom - would like you to believe otherwise.

I am struggling to find a source for the quote, but I read recently that the amount of prescription drug mistakes in US hospitals approaches one per patient per day. Completely insane. In college, a med student I knew who was in their residency told me "if you don't want to get sick, stay away from hospitals". Yipes.

edit: here it is:
http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=11623

Errors are common at every stage, from prescription and administration of a drug to monitoring of the patient's response, the committee found. It estimated that on average, there is at least one medication error per hospital patient per day, although error rates vary widely across facilities.

Simply unbelievable.

 

[JohnK]

Yep, guess they blew their enrollment #'s. I was the only one at my site from Oct 2014 - July 2015. I've touched based with the trial nurse a few times and they still haven't had anyone else.

Where are you? My site (one of the ones in southern California) was talking about enrolling another 2 right after me and that they're getting close to their 33 enrollee ceiling

 

[papu]

@spime just go for it your are in and you are a perfect candidate don't loose the opportunity you might be the fourth one cured. Even though I went through two rounds of three injections in both ears and my tinnitus did not change, I did not get any permanent damage. Whatever you feel or hearing loss that you experience will recover in two to three weeks. The injection in my case were painless and what I hated the most is not swallowing for half and hour. Do practice before going not swallowing it's hard. I had a little hyperacusis after thw second set and a little bit of hearing loss but everything came back to normal after 21 days by that time I quit the trial and although I feel that the real medicine did not work on me I wish now I would have done the third set. So go for it if you don't you might regret it later.

 

[Nucleo]

anyone have any info on why EARS has jumped so high in the stock market?

Well it's going back down now. Speculation.

 

[JohnK]

I've just had the last of the 3 injections. (well, 6 since I got it in both ears).

T is louder (a solid 6) and sound is more muffled. Here's hoping it wasn't placebo!

 

[JohnK]

Post-injection update: My T seemed to go down to 1 for a few minutes. Crept back up, but that was a pleasant surprise

 

[spime]

Post-injection update: My T seemed to go down to 1 for a few minutes. Crept back up, but that was a pleasant surprise

@spime just go for it your are in and you are a perfect candidate don't loose the opportunity you might be the fourth one cured. Even though I went through two rounds of three injections in both ears and my tinnitus did not change, I did not get any permanent damage. Whatever you feel or hearing loss that you experience will recover in two to three weeks. The injection in my case were painless and what I hated the most is not swallowing for half and hour. Do practice before going not swallowing it's hard. I had a little hyperacusis after thw second set and a little bit of hearing loss but everything came back to normal after 21 days by that time I quit the trial and although I feel that the real medicine did not work on me I wish now I would have done the third set. So go for it if you don't you might regret it later.

Yeah I'm still going along with the AM-101. Wondering how much time off work is required or if I can take a half day. I did have hearing loss only in my left ear based off the hearing test during the screening. December 11, 2015 was the noise trauma incident (firing range) so I am just about 3 full weeks in. I was hoping to get the first round injections today after the screening and then Monday/Tuesday for the other rounds --but they said come back 1/25-27.

Currently at a 4/10, my desktop is masking the Tinnitus pretty well. It could be I'm just getting use to it because I am only ringing in the left ear, right ear is fine.

When you quit the trial did the immediately tell you if you got the medicine or the placebo? Thanks for the encouragement!

 

[papu]

When you quit the trial did the immediately tell you if you got the medicine or the placebo? Thanks for the encouragement!

You will never know until you meet the creator

 

[JohnK]

@spime if you don't need to travel a lot then half a day should be fine. If the trial were in the same city as my office I would definitely have been okay go go to work after.

 

[JohnK]

Update 1 day after injections:

T is still louder (6) and sound is a bit muffled. It's like someone turned down the "trebel" knob on everyday life.

Ears feel full but not painful (except when I'm trying to shove earplugs in them for the shower).

So far the biggest improvement is psychological...I was proactive and DID something about the T. So even though I still hear the sound, it somehow bothers me a bit less.

 

[RaZaH]

@JohnK crossing fingers and toes for you !

 

[JohnK]

Does anyone who has gone through the trial know what the rules are on intake of caffeine and alcohol?

I can certainly go the 90 days without them if I have to, but I'd rather not

 

[liquefact]

I consumed beer after the injections, one 6 pack in ~10 days. I don't think it's a problem. Caffeine is something I'd always avoid though.

 

[papu]

Does anyone who has gone through the trial know what the rules are on intake of caffeine and alcohol?

I can certainly go the 90 days without them if I have to, but I'd rather not

As far as I know their is no restriction and at least in my case caffeine does not lower or made worst my tinnitus.

 

[JohnK]

Day 2 after injections:

Sound is a bit muffled still but less so than yesterday

Tinnitus is pretty good today,back down to 5 or maybe even 4.

It also seems somehow indescribably...different in how it sounds. More...soft in tone, if not volume...

Could all be in my head, but if this tend continues then keep up the good work, John's head!

 

[Stotoph]

Hey guys I just want drop in.


Im a Chronic Tinnitus sufferer and got in the AM-101 trail few months ago and it really helped lower my Tinnitus.


I'll keep it short.


I had Tinnitus in my left ear only in 2011 after a throat infection, no hearing loss even in the high frequencies. I would rate the Tinnitus a 4/10. After a few months the Tinnitus reduced to a 0.5/10. It never spiked, I could eat all I want, stress all I want. The only time I heard it was when I would plug my ears and reallllyyyy concentrate hard. You can basically say that I lived a tinnitus free live.


In 2015 I was watching TV and all of a sudden out of nothing my Tinnitus increased to a 8/10 in both ears and the middle of my head. Went trough the same cycle, ENT, Prednisone, no hearing loss bla bla bla..


I applied for the AM-101 trail. I won't say how I got in because I'm a chronic sufferer, but the trail people didn't know that.. lets just keep it to that.


I got the injections when I was 2,5 months in and to be honest I read all the scary story's in this thread so I was expecting some horror shit, but to be honest it wasn't all that bad. I had some pain in my right ear that still bothers me when I wake up after my third injection but that was it.

After 2 days I didn't even feel if I had the injections or not, sometimes I tend to think that people here are really overdramatic if I may be so bold to say that. So if you're deciding to go for the the trail I would say just go!


After two weeks I woke up and my Tinnitus was reduced from a 8/10 to a fluctuating 3-4/10. My right ear Tinnitus and the Tinnitus in the middle of my head is reduced so much that I almost never hear them anymore. Its only my left ear that still bothers me a bit but I'm extremely happy with this result.


I didn't do the follow up because I still have some pain in my right ear when I wake up and I didn't want to make it worse.


Currently I'm taking Trobalt to see if I can reduce the volume back to 0.5/10 hopefully.


Anyway I wanted to post this because I wanted to give hope to all you chronic sufferers that this does work for us long time sufferers!


Made a pic during my trail incase ya'll wanted some proof.


Hope everyone has a Tinnitus free year!

 

[Charlie396]

Well done Mr. Bond

 

[Kane Moffat]

A chronic sufferer getting significant relief? Interesting

 

[Alue]

After two weeks I woke up and my Tinnitus was reduced from a 8/10 to a fluctuating 3-4/10. My right ear Tinnitus and the Tinnitus in the middle of my head is reduced so much that I almost never hear them anymore. Its only my left ear that still bothers me a bit but I'm extremely happy with this result.

Interesting. I'm still learning about this, but is there any differentiation from tinnitus that seems to originate in the ear and tinnitus that seems to originate in the middle of your head? I would think if it's random firing in the coclea it might be more localized to the ear, but if it seemed it originated from the middle of your head it could be more chordal?

I hope that made sense, I'm tired, new to all this, and the T is screeching in my head right now.

 

[Joe Bananas]

I read all the scary story's in this thread so I was expecting some horror shit

About to undergo the injections part of the trial in a couple of weeks and haven't read any horror story so far... Don't know if I want to... glub!. Just reading
@liquefact experience makes me hesitate a bit...

 

[JohnK]

Day 3 after injections:

Ears feel more normal, less muffled and sensitive to the touch. Still plugging my ears before the shower and I'll be doing that until I'm told otherwise.

T is back to being a high 5.