Otonomy OTO-313 — Treatment of Tinnitus

[Philip83]

Does anyone know where they usually publish the information to be involved trials?

If it's rolling out in Europe I'd definitely like to take part.

To qualify you need to be in the 6 months to 12 months window of your initial tinnitus onset.

 

[Jimmyboi]

To qualify you need to be in the 6 months to 12 months window of your initial tinnitus onset.

Do you have a source for this information? I'm struggling to find anything concrete.

 

[prowlinacage]

To qualify you need to be in the 6 months to 12 months window of your initial tinnitus onset.

I'm right at 11 months. I'm sure the candidates are selected already.

 

[Gee82]

I'm right at 11 months. I'm sure the candidates are selected already.

How do you know?

 

[Jimmyboi]

Otonomy Provides Update on OTIVIDEX® and OTO-313 Programs

I found a source that talks about changes for Phase 2.

This suggests they're excluding severe hearing loss.

Increasing minimum TFI score (targeting worse tinnitus).

Increasing time since onset (aiming more toward chronic tinnitus).

This all seems really good to me.

 

[Lucifer]

Otonomy Provides Update on OTIVIDEX® and OTO-313 Programs

I found a source that talks about changes for Phase 2.

This suggests they're excluding severe hearing loss.

Increasing minimum TFI score (targeting worse tinnitus).

Increasing time since onset (aiming more toward chronic tinnitus).

This all seems really good to me.

It's good that OTO-313 is moving onto Phase 2 but I'm pissed that OTO-413 had good results in Phase 1 and they are repeating it again.

 

[Jimmyboi]

OTO-313 in Subjects With Unilateral Subjective Tinnitus

Looks like it was just posted today.

I don't see any obvious sign of EU participation.

Still looking at 'early onset unilateral' tinnitus.

It has contacts available for those interested.

 

[Mentos]

I have had moderate head tinnitus (crickets) for 6 years already, plus unilateral buzzing in left ear which I developed around 6 months ago.

OTO-313 will be tested in my home town in Poland.

@FGG, do you think it makes sense for me to enroll? I don't want to jeopardise the results by testing the drug on 6-year-old head tinnitus. Although, I do have a new acute component in my left ear which I would target with the trial.

Obviously I would check as well if my chronic part of tinnitus was changed by the trial.

 

[Gee82]

I have had moderate head tinnitus (crickets) for 6 years already, plus unilateral buzzing in left ear which I developed around 6 months ago.

OTO-313 will be tested in my home town in Poland.

@FGG, do you think it makes sense for me to enroll? I don't want to jeopardise the results by testing the drug on 6-year-old head tinnitus. Although, I do have a new acute component in my left ear which I would target with the trial.

Obviously I would check as well if my chronic part of tinnitus was changed by the trial.

Where did you find out about the trial's location? Do you know if there are any other European sites?

 

[FGG]

I have had moderate head tinnitus (crickets) for 6 years already, plus unilateral buzzing in left ear which I developed around 6 months ago.

OTO-313 will be tested in my home town in Poland.

@FGG, do you think it makes sense for me to enroll? I don't want to jeopardise the results by testing the drug on 6-year-old head tinnitus. Although, I do have a new acute component in my left ear which I would target with the trial.

Obviously I would check as well if my chronic part of tinnitus was changed by the trial.

My guess is that they wouldn't consider that unilateral tinnitus but you could contact them and ask.

 

[Mentos]

Where did you find out about the trial's location? Do you know if there are any other European sites?

I heard it directly from my ENT who was involved in OTIVIDEX trials in my home town. I have no info about other locations.

 

[Tezcatlipoca]

I have had moderate head tinnitus (crickets) for 6 years already, plus unilateral buzzing in left ear which I developed around 6 months ago.

OTO-313 will be tested in my home town in Poland.

@FGG, do you think it makes sense for me to enroll? I don't want to jeopardise the results by testing the drug on 6-year-old head tinnitus. Although, I do have a new acute component in my left ear which I would target with the trial.

Obviously I would check as well if my chronic part of tinnitus was changed by the trial.

Please do not enroll. Look at the FX-322 fiasco, you're way out of the recruitment parameter.

 

[kingsfan]

Am I reading this correctly? The trial is being conducted in Florida and North Carolina? When the headquarters is in San Diego?

I have now sent an email out to Otonomy about any additional locations. I'll update everyone on their response.

 

[Mentos]

Please do not enroll. Look at the FX-322 fiasco, you're way out of the recruitment parameter.

I will be transparent about my symptoms and tinnitus duration, it's up to trial coordinator to decide if I'm eligible.

 

[FGG]

Am I reading this correctly? The trial is being conducted in Florida and North Carolina? When the headquarters is in San Diego?

I have now sent an email out to Otonomy about any additional locations. I'll update everyone on their response.

Yes, those are the listed sites. Companies contract with testing labs to remove bias so it's not at all unusual to test nowhere near headquarters.

 

[FGG]

I will be transparent about my symptoms and tinnitus duration, it's up to trial coordinator to decide if I'm eligible.

For the record, I think a big reason it needs to be unilateral is probably because how do you accurately measure the true impact of having tinnitus decline if you have it in both ears but only treat one ear?

The fact that you have been on this forum longer than 6 months tells me it is extremely unlikely you would be a good candidate because it's clear the other tone still bothers you.

I would be really surprised if they weren't strict about this and I think they should be.

 

[Mentos]

For the record, I think a big reason it needs to be unilateral is probably because how do you accurately measure the true impact of having tinnitus decline if you have it in both ears but only treat one ear?

The fact that you have been on this forum longer than 6 months tells me it is extremely unlikely you would be a good candidate because it's clear the other tone still bothers you.

I would be really surprised if they weren't strict about this and I think they should be.

Thanks for your point of view on that. I'm not happy but I think I have to agree with you. What about compassionate use, can this be applied for in Phase 2? Do they need to comply with US regulation or EU regulation where the testing takes place? Perhaps this might be an option for me not to lose the opportunity to try the drug.

 

[VeryUnfortunate]

Can anyone fill me in about why there isn't that much hype about OTO-313? This a treatment that is actually being tested just for tinnitus, while most of the other treatments are initially being tested for something else.

I really hope OTO-313 is successful, although I am not sure about how it works.

 

[Toby1972]

Thanks for your point of view on that. I'm not happy but I think I have to agree with you. What about compassionate use, can this be applied for in Phase 2? Do they need to comply with US regulation or EU regulation where the testing takes place? Perhaps this might be an option for me not to lose the opportunity to try the drug.

It seems that there are no studies in Europe.

OTO-313 in Subjects With Unilateral Subjective Tinnitus

 

[Gb3]

@Mentos, please don't screw this trial up.

 

[Ehren M]

To qualify you need to be in the 6 months to 12 months window of your initial tinnitus onset.

I just spoke with a recruiter for the current Phase II trial and wanted to provide updated information regarding eligibility for this trial.

They require that participants have had tinnitus for over 2 months, not 6 months. The recruiter did not mention a maximum time of experiencing tinnitus allowed in the study, though I suspect it is 12 months or so.

They did ask me whether I had uni- or bi-lateral symptoms. I noted that I have moderate tinnitus in my left ear and mild tinnitus in my right ear. Still, they were happy to refer me onward for a screening visit, so apparently my bilateral symptoms were not disqualifying.

The only study locations in the USA, so far, are in the southeast.

The full trial requires that participants visit the study location 6 times (once for a screening visit, once for the treatment, and 4 times during the course of the study, with each visit spaced approximately 1 month apart).

Where some double-blind studies apparently administer the test drug to all participants after the trial period concludes, this study apparently does not plan to do that, so I am not yet sure I'll participate since the trial location is not close to me and it's a craps-shoot that I would receive the drug. I would definitely participate all the same if I were near a trial location!

It appears that they are still recruiting people.

 

[Mentos]

It seems that there are no studies in Europe.

OTO-313 in Subjects With Unilateral Subjective Tinnitus

Indeed European sites are not listed there, but Otonomy stated at their last update they will conduct trials in Europe, plus I know they were conducting trials with OTIVIDEX in my town, hence I suspect/speculate they will do the same with OTO-313.

Unfortunately for me, I probably do not meet the eligibility criteria.

 

[Gb3]

What were the results from the Phase I study? Any indication on improving tinnitus?

 

[Ehren M]

I just spoke with a recruiter for the current Phase II trial and wanted to provide updated information regarding eligibility for this trial.

They require that participants have had tinnitus for over 2 months, not 6 months. The recruiter did not mention a maximum time of experiencing tinnitus allowed in the study, though I suspect it is 12 months or so.

They did ask me whether I had uni- or bi-lateral symptoms. I noted that I have moderate tinnitus in my left ear and mild tinnitus in my right ear. Still, they were happy to refer me onward for a screening visit, so apparently my bilateral symptoms were not disqualifying.

The only study locations in the USA, so far, are in the southeast.

The full trial requires that participants visit the study location 6 times (once for a screening visit, once for the treatment, and 4 times during the course of the study, with each visit spaced approximately 1 month apart).

Where some double-blind studies apparently administer the test drug to all participants after the trial period concludes, this study apparently does not plan to do that, so I am not yet sure I'll participate since the trial location is not close to me and it's a craps-shoot that I would receive the drug. I would definitely participate all the same if I were near a trial location!

It appears that they are still recruiting people.

Update:

The trial recruiter just now informed me that clinics in the following locations will also participate in the trial:

• St. George, UT — Site not active yet
• Colorado Springs, CO — Site not active yet
• Aurora, CO — Site not active yet
• Fresno, CA — Site is active

Not sure what the hold up is with ENTs in the Pacific Northwest...

 

[VeryUnfortunate]

Update:

The trial recruiter just now informed me that clinics in the following locations will also participate in the trial:

• St. George, UT — Site not active yet
• Colorado Springs, CO — Site not active yet
• Aurora, CO — Site not active yet
• Fresno, CA — Site is active

Not sure what the hold up is with ENTs in the Pacific Northwest...

Interesting. I talked to them today too (Otonomy's HQ) and they informed me that it's only the two locations in Florida and North Carolina that are recruiting right now.

 

[kingsfan]

How did you all get in contact with Otonomy so fast? I sent an email last week but haven't heard back from anyone.

 

[Ehren M]

Interesting. I talked to them today too (Otonomy's HQ) and they informed me that it's only the two locations in Florida and North Carolina that are recruiting right now.

@VeryUnfortunate and @kingsfan,

I sent them 3 emails in a row, all respectful, but prodding for info. Also, they didn't volunteer the info about additional study locations until I mentioned it would be difficult for me to get across the country 6 times during the trial.

 

[kingsfan]

I sent them 3 emails in a row, all respectful, but prodding for info. Also, they didn't volunteer the info about additional study locations until I mentioned it would be difficult for me to get across the country 6 times during the trial.

Ah so they are probably just avoiding me. Their press release states "50 clinical sites in the U.S. and Europe" so I'm assuming more locations will be announced.

 

[Ali.sy]

It is not specified if you must have had tinnitus for ten years, or a month.

Here is the eligibility criteria for the trial:

 

[Matchbox]

I wonder if Otonomy would be open to a private trial by a local ENT. I'm in Canada, which makes shit hard for clinical trials. We don't do them here... ever.