Should I Sign Up for AM-101?

Do you think I should? My father doesn't think I should do it, but I'm running out of time because I read the trial ends in February, which is NOW, and I'm already 8 weeks into having T and it hasn't gotten better. I still have ETD, but I'm going to an ENT Thursday to hopefully put an end to that once and for all. I honestly can't live much longer like this. Read my story (if you want) and tell me what you think I should do.

 

I absolutely think you should sign in and go to the screening.

But be mindful that if you have ETD as a result of some sort of infection you might not get in.

Here and the inclusion/exlusion criteria:

Inclusion Criteria:

1. Persistent subjective peripheral tinnitus (unilateral or bilateral) following traumatic cochlear injury (acute acoustic trauma, blast trauma, middle ear surgery, inner ear barotrauma, tympanic membrane trauma) or otitis media with onset no longer than 3 months (Stratum A) or between >3 months and 6 months (Stratum B) prior to randomization
2. Age ≥ 18 years and ≤ 75 years;
3. Negative pregnancy test (woman of childbearing potential);
4. Willing and able to use adequate hearing protection, respectively to refrain from engaging in activities or work involving loud noise exposure where sufficient hearing protection is not possible or ensured;
5. Willing and able to protect ear canal and middle ear from water exposure as long as tympanic membrane is not fully closed.

Other protocol-defined inclusion criteria may apply.

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.

 

I hope you get your ETD resolved finally and your T goes down. I went to a ENT this morning and asked about my E-tubes and TMJD. He told me about a specialist that puts some kind of balloon through your E-tubes and possibly opens them up if they are not normal. I will see him mid Feb. Your new ENT might advise you on the AM-101 trials or someone here possibly, but you would only have a 50% chance on getting the real deal I believe if you're eligable.

 

Who does not have fluctuating T ? Anyone ?

 

It's entirely up to you. If I could go back in time and do it, I don't think I would... Invasive, 50/50 chance of getting placebo. That's just my own opinion, though.

Edit: two years ago I would have sworn until I was blue in the face that I absolutely would have done it if given the chance, too...

 

You're only 8 weeks in. ETD can take ages to resolve. Ask for an endoscopy and ask them as many questions as possible.

 

Yes you should, do not miss this unique chance.

 

Where did you read the trial ends in February?

I'd give it a shot. Doesn't hurt to go to the screening and get another assessment.

I don't. Mine is constant high pitched and unrelenting.

 

I read it on this site, in the trials section. I mean, they have to stop the trial sometime, and how long has it been going on?

 

I do recall reading that somewhere. I can't seem to find it now, I think that may have been their projected date when the began the trials. You are right, though, it looks like they are at the tail end of the study. It's not uncommon for phase III drug trials to take years to finish.

 

https://clinicaltrials.gov/ct2/results?term=am-101&Search=Search
each trial has an estimated completion date.

 

Just curious @Hotaru, why does your dad think you shouldn't do AM 101?

 

Estimated is the key word.
Hmm it mentions February for TACTT2 and TACTT3 and then October 2016 for AMPact2.

AmPact2 is just the open-label followup correct?

 

That's interesting. I will have to look into something like that for my ETD. Good luck on your appointment !

 

My dad doesn't like any kind of drug, especially test drugs. He's a natural healing kind of guy, but I need fast and immediate results. I refuse to live like this.

 

Well, all clinical trials do carry risks. The medication could make your condition worse. Or it could do nothing at all. My ENT, a barotrauma specialist, thinks the AM-101 results he has seen so far are underwhelming.

But I have to say that if I had the opportunity, I would go for the trial. I applied here in Miami but was rejected, because I had tinnitus more than three months. I think most of the trials now are for acute onset (three months or less) so if you are interested, hope you go for it. It will be too late later.

 

I do not know what results your ENT saw but there has been some interim results published and they are not underwhelming.

https://www.tinnitustalk.com/thread...dates-and-discussion.6558/page-20#post-119473

AM-101 is a unique opportunity to do something about your tinnitus still in the acute phase that you will never get in the future.

Stick to the facts people.

 

I would sign up. No risks and you can get better.

 

I wouldn't say it's no risk, but it is low risk. Worth a shot in my opinion if you are in the 'acute' stage.

 

@John G, My left Eustachian tube has been very troublesome and this Dr. that uses a balloon to open up a abnormal one could be a ray of hope. That is the side that causes my loud left ear tinnitus at times and also bothered me on airplanes. I have left TMJD also, so a bit confusing? I will update after the appt.

 

Thanks buddy. I really hope you found the problem. Please keep us updated.

I have TMJ with ETD,so your post gave me hope also

 

How long will it take for them to get back to me? I sent my application on the 1st.

 

Is your noise still very loud? Mine is loud upon awakening like many here. Someone else will answer your ? on AM-101. You could always look into Otonomy later on. I assume you live in the U.S. but you don't have to say. I thought a major ear clinic in the US might be more helpful if you did.

 

Are there any more AM 101 test going on?If so how do you get involved?

 

http://tinnitus-study.info/us-en-the-study

Here. Hurry and sign up; testing is ending soon.

 

I got back from getting the injections. They really weren't bad. I've dealt with worse pain, much worse. Get them if you can, but honestly, I wish the trial was shorter. I had to travel pretty far and still do for my three follow-ups. That's right, one after ten days, one after thirty days, and one after 3 months. I don't get why it takes that long for the trial to be completed. People have noticed a change in their T within two weeks. Honestly, I don't know if I can wait that long. If this doesn't work, I need to try something else for the T as quickly as possible.