AM-101 in the Treatment of Acute Tinnitus (TACTT3)

[Tinnitus Talk]

Tinnitus Talk submitted a new resource:

AM-101 in the Treatment of Acute Tinnitus 3 (TACTT3) - The purpose of this research study is to test the safety and effectiveness of the study drug, AM-101

The purpose of this research study is to test the safety and effectiveness of the study drug, AM-101.
AM-101 is tested for the treatment of tinnitus that started as the result of an injury to the inner ear or due to middle ear inflammation (otitis media). Subjects with tinnitus can take part in the study, if their tinnitus started within the last 3 months or within the last 4 to 6 months.

TACTT3 (AT, BE, FR, DE, HU, PL, CH, UK, ES):
Tinnitus onset no longer than 3 months (Stratum A) or between 3 months and 6 months (Stratum B) prior to randomization
Estimated Enrollment: 600
Study Start Date: January 2014
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)

Read more about this resource...

 

[Hudson]

http://clinicaltrials.gov/ct2/show/NCT02040194?term=am-101&rank=1

It looks like Auris has started a new Phase 3 trial for AM-101, and is currently recruiting. This one includes folks who are up to 12 months from onset of their tinnitus. This is pretty exciting! I have no idea about US participation but I think there are many multiple sites in the US that are participating in this though, given what I have heard. Have at it folks, and if you do meet inclusion criteria and you participate, it would be much appreciated if you share your experiences here on TT.

EDIT: It looks like Auris has multiple Phase 3 trials they are conducting now. This will be an expensive professional effort. My guess is that if they go well, it won't be too long before a drug like this makes it to market after the trials are completed.

 

[Tenna]

Thats really neat, can someone explain the primary and secondary outcome measures? Im not sure to make of the yays and nays, but dont they seem a bit worrying some of them, or can any conclusions be drawn based on the knowledge leaked? thanks

 

[Jake]

After contacting one of the supervising doctors at the University of Kansas Medical Center, I was told that I will be given enrollment information after all of the specifics are worked out. I will keep all of you updated through the process if everything goes as planned.

 

[Hudson]

Thats really neat, can someone explain the primary and secondary outcome measures? Im not sure to make of the yays and nays, but dont they seem a bit worrying some of them, or can any conclusions be drawn based on the knowledge leaked? thanks

Secondary outcomes are less empirically driven and are more like icing on the cake. You may notice overlap between the primary outcomes and secondary outcomes, with the corresponding secondary outcomes taking place at a later date from the treatment than the primary ones. The primary outcomes engender the most useful and important data for regulatory approval. The secondary ones may be used to supplement safety information or marketing data to the patient.

 

[Erlend]

After contacting one of the supervising doctors at the University of Kansas Medical Center, I was told that I will be given enrollment information after all of the specifics are worked out. I will keep all of you updated through the process if everything goes as planned.

Can you please post the contact information here? There was this one member who was really frustrated as he fits the criteria but he couldn't find the contact information

 

[Tenna]

Secondary outcomes are less empirically driven and are more like icing on the cake. You may notice overlap between the primary outcomes and secondary outcomes, with the corresponding secondary outcomes taking place at a later date from the treatment than the primary ones. The primary outcomes engender the most useful and important data for regulatory approval. The secondary ones may be used to supplement safety information or marketing data to the patient.

Mmm icing on cake!.. yeah that was what caught my attention. Information is sparse on those, and one sideffect could vary so much in degree. Lose tinnitus, become deaf? How much deterioration of hearing treshold, what is defined as a (serious) adverse effect? :-O

 

[Hudson]

Can you please post the contact information here? There was this one member who was really frustrated as he fits the criteria but he couldn't find the contact information

You can do like I have done and email different doctors at ENT clinics at universities in your area and ask them if they are participating or if they know of a that is.

 

[Amelia]

I hope I'm reading this right ... But this sounds very exciting! Wish I was in the US now!

 

[Hudson]

I hope I'm reading this right ... But this sounds very exciting! Wish I was in the US now!

This is a pretty broad clinical trial. I would not be surprised if there were some locations in Aussie land participating

 

[yonkapin]

Awesome news that things are moving along now. The hearing threshold stuff concerns me though.

 

[Stina]

Thats really neat, can someone explain the primary and secondary outcome measures? Im not sure to make of the yays and nays, but dont they seem a bit worrying some of them, or can any conclusions be drawn based on the knowledge leaked? thanks

are you thinking about participating? I think it would be ok for all the EU member probably?

 

[frohike]

are you thinking about participating? I think it would be ok for all the EU member probably?

https://www.clinicaltrialsregister.eu/ctr-search/search?query=Ear+Diseases

Efficacy and Safety of AM-101 in the Treatment of Acute Peripheral Tinnitus 3 (TACTT3)
Country: HU(Ongoing) BE(Ongoing) AT(Ongoing) GB(Ongoing)

 

[Tenna]

@Stina arent we all the outcome measures are just of concern to me. Outcome of hearing treshold stated like that can range from almost zero to significant. Also the adverse effects and serious adverse effects hm! troublesome

 

[RaZaH]

Hearing Threshold ? Am I missing something ? Are there known sideeffects from this ?

 

[Stina]

Hearing Threshold ? Am I missing something ? Are there known sideeffects from this ?

yap it can result in significant hearing loss.

 

[RaZaH]

Eh...ok , nevermind then .

 

[Stina]

Eh...ok , nevermind then .

Yeah you can get of Tinnitus AND all the other sounds as well!

 

[RaZaH]

I'm good !

 

[Hudson]

yap it can result in significant hearing loss.

Do you have any data showing that it has ever resulted in "significant" hearing loss for any individual? The safety studies have shown that:


"Preliminary results from the TACTT1 study show that both single and triple dose treatments with AM-101 were well tolerated. Occurrence of adverse events or clinically relevant hearing loss overall was low to moderate with no statistically significant differences between treatment groups and dose regimens. As in the previous studies with AM-101, most adverse events were mild or moderate in intensity and represented transient local effects of the injection procedure. At <0.2 ng/mL, the concentrations of AM-101's active substance and primary metabolite in blood plasma were close to the analytical limits of quantification, thus confirming the minimal systemic exposure offered by the intratympanic approach."

Thousands of intratympanic injections take place every year. I don't think that it's a given that you will experience a hearing threshold decrease, nor do I think it would be major or permanent if you did. As stated above, most of the adverse events were related to the injection procedure, which heals pretty fast.

 

[Stina]

Do you have any data showing that it has ever resulted in "significant" hearing loss for any individual? The safety studies have shown that:


"Preliminary results from the TACTT1 study show that both single and triple dose treatments with AM-101 were well tolerated. Occurrence of adverse events or clinically relevant hearing loss overall was low to moderate with no statistically significant differences between treatment groups and dose regimens. As in the previous studies with AM-101, most adverse events were mild or moderate in intensity and represented transient local effects of the injection procedure. At <0.2 ng/mL, the concentrations of AM-101's active substance and primary metabolite in blood plasma were close to the analytical limits of quantification, thus confirming the minimal systemic exposure offered by the intratympanic approach."

Thousands of intratympanic injections take place every year. I don't think that it's a given that you will experience a hearing threshold decrease, nor do I think it would be major or permanent if you did. As stated above, most of the adverse events were related to the injection procedure, which heals pretty fast.

So the hearing loss stated as a threat is probably just a permanent traumatic reaction to the injections?

 

[Erlend]

yap it can result in significant hearing loss.

where are you guys getting this from?

 

[yonkapin]

Do you have any data showing that it has ever resulted in "significant" hearing loss for any individual? The safety studies have shown that:


"Preliminary results from the TACTT1 study show that both single and triple dose treatments with AM-101 were well tolerated. Occurrence of adverse events or clinically relevant hearing loss overall was low to moderate with no statistically significant differences between treatment groups and dose regimens. As in the previous studies with AM-101, most adverse events were mild or moderate in intensity and represented transient local effects of the injection procedure. At <0.2 ng/mL, the concentrations of AM-101's active substance and primary metabolite in blood plasma were close to the analytical limits of quantification, thus confirming the minimal systemic exposure offered by the intratympanic approach."

Thousands of intratympanic injections take place every year. I don't think that it's a given that you will experience a hearing threshold decrease, nor do I think it would be major or permanent if you did. As stated above, most of the adverse events were related to the injection procedure, which heals pretty fast.

Thanks for clearing that up!

 

[Erlend]

So the hearing loss stated as a threat is probably just a permanent traumatic reaction to the injections?

Do you mean temporary? It is normal for the ear drum to burst even if you're just sick sometimes. Happened to my dad when he was a kid. It heals.

 

[Stina]

Do you mean temporary? It is normal for the ear drum to burst even if you're just sick sometimes. Happened to my dad when he was a kid. It heals.

jep meant temporary. Well maybe its worth contacting them and asking whether they will include people from other Eu countries as well. Unlikely but asking couldnt hurt.

 

[Grace]

Hey all i know this question has been asked on here a thousand times.. But with everyones opinion what do you think the chances of this treatment helping chronic t is...

 

[Tenna]

Phew thanks @Hudson for restoring order

 

[Amelia]

I will just chime in and say the eardrum doesn't always heal ... My daughter had grommets a few years ago and her ears never healed - we will need to get her her drums patched when she is older.
It's rare tho.

 

[Garden Ring]

My concern was: if am101 is basically a substance which inhibits transmission of signal from cochlea to the brain to decrease the strength of tinnitus signal, wouldn't it decrease the level if good signal as well?
It's like removing the whole antenna when you start having statics on your TV.
But this concern is quite an obvious one, and I guess the guys who develop this treatment are not idiots.

Still would like an explanation, though.

 

[watie]

Hay Jake
Do you have a phone number or other information on how to check on enrollment in the AM 101 study at KU Medical center. I live close to Wichita and my T started about the same time as yours. Thanks for any information you could share.