AdventHealth Research Institute Offers Phase II Clinical Trial of Etanercept for Treatment of Blast-Induced Tinnitus

[vttbx]

AdventHealth Research Institute Offers Phase II Clinical Trial of Etanercept for Treatment of Blast-Induced Tinnitus

Under the leadership of principal investigator Michael Seidman, MD, AdventHealth Research Institute is participating in the multi-site Clinical Trial of Etanercept (TNF-alpha Blocker) for Treatment of Blast-Induced Tinnitus funded by the U.S. Department of Defense.

The purpose of this research study is to determine if etanercept, compared to a placebo, significantly reduces the severity of tinnitus (ringing in the ears) associated with history of blast and/or noise exposure or associated with traumatic brain injury (TBI) and/or concussion. The primary objectives are to test if:

• Etanercept significantly reduces tinnitus distress as measured by the Tinnitus Functional Index (TFI), a self-report questionnaire used to assess the severity and negative impact of tinnitus (tinnitus distress).
• Etanercept improves hearing as measured through audiometric testing, tinnitus testing, a visual numeric rating scale to rate the loudness of the tinnitus, and a tinnitus primary function questionnaire. In addition, investigators will explore whether etanercept treatment leads to sustained therapeutic effects over time.

The secondary objective of this study is to test if etanercept reduces tinnitus loudness measured by visual numeric scale (VNS) rating.

 

[Saba]

This is interesting. Wayne State University in Detroit had an open enrollment in the spring to recruit candidates with tinnitus resulting from noise-induced trauma. They were planning to test the same drug, also known as Enbrel, to determine whether this treatment can reduce tinnitus distress.

I passed the screening but was rejected due to a questionable blood test. From what I understand, the clinical trial at Wayne State is expected to be completed by August 2025.

 

[withintention]

That is exciting. It sounds like there was an anecdotal case of someone whose hearing was improved while on a drug that had a similar mechanism of action.

 

[StoneInFocus]

AdventHealth Research Institute Offers Phase II Clinical Trial of Etanercept for Treatment of Blast-Induced Tinnitus

Dirk de Ridder has also suggested using TNF-alpha blockers in the treatment of tinnitus.

 

[AfroSnowman]

Dirk de Ridder has also suggested using TNF-alpha blockers in the treatment of tinnitus.

View attachment 61340

Did he actually do this study?

 

[vttbx]

I received more information about the study, in case anyone is considering participating. It is best if you live in Michigan or Florida.

Unfortunately, we only have sites open in Michigan and Florida and the study requires weekly/in person visits for the first 12 weeks (14 visits total over 16 weeks).

 

[gracepixie]

For what it's worth, I signed up for more information about this trial and was promptly contacted by someone from the team to check if I qualified. At first, I thought it was only for veterans, but civilians are eligible as well. Unfortunately, I cannot participate because I am unable to travel to Florida on a weekly basis. However, if you are located near a treatment site, please consider signing up to help them reach their enrollment goal.

 

[Tim]

I had a call with Dr. Seidman to connect and hear about the early results from his study. Instead, he gave me a current status update: they are facing major problems recruiting patients. This is not because of serious side effects, but rather because they are not entirely sure why participation is so low.

Dr. Seidman said he would appreciate it if I shared this information online, so I am doing that here.

He believes too few people know about the trial and that the biggest barrier may be the requirement to travel to the study site once a week for 10 weeks, which is about three months. Personally, I find it hard to understand why, if you suffer from tinnitus, you would not consider that effort worthwhile.

This work is being funded with millions from the U.S. Department of Defense and could potentially help even in chronic cases. As Dr. Seidman himself said, it could help "billions of people." It would be a real shame if this funding went to waste. What message would that send? That tinnitus does not truly require treatment? That patients are not willing to commit to a weekly injection for a few months?

And what would that mean for us as a community? Most likely, the next time, the U.S. Department of Defense will not invest millions again, but instead conclude that tinnitus may not be such a pressing issue after all. That thought deeply troubles me, and I simply cannot understand how such a situation can happen.

 

[DimLeb]

I had a call with Dr. Seidman to connect and hear about the early results from his study. Instead, he gave me a current status update: they are facing major problems recruiting patients. This is not because of serious side effects, but rather because they are not entirely sure why participation is so low.

Dr. Seidman said he would appreciate it if I shared this information online, so I am doing that here.

He believes too few people know about the trial and that the biggest barrier may be the requirement to travel to the study site once a week for 10 weeks, which is about three months. Personally, I find it hard to understand why, if you suffer from tinnitus, you would not consider that effort worthwhile.

This work is being funded with millions from the U.S. Department of Defense and could potentially help even in chronic cases. As Dr. Seidman himself said, it could help "billions of people." It would be a real shame if this funding went to waste. What message would that send? That tinnitus does not truly require treatment? That patients are not willing to commit to a weekly injection for a few months?

And what would that mean for us as a community? Most likely, the next time, the U.S. Department of Defense will not invest millions again, but instead conclude that tinnitus may not be such a pressing issue after all. That thought deeply troubles me, and I simply cannot understand how such a situation can happen.

All good points, but the big organizations and government departments already believe tinnitus is not a pressing issue, and this has been the case for years.

 

[IYIiKe]

Personally, I find it hard to understand why, if you suffer from tinnitus, you would not consider that effort worthwhile.

Once a week for ten weeks likely means someone local still taking about 2-4 hours of leave a week or going without work for that time, making the commitment in time/money and effort for a 50% chance to receive an experimental drug.

 

[alwaysmasking]

I imagine a lot of it comes from a place of: "But what if it makes it worse?". There's a large pool of people with tinnitus, but a much smaller pool of people with tinnitus that is so bad that they'll take the risk of worsening just for some relief.

(Not saying that this treatment would do that; but with this condition, fear is omnipresent, and even were every scientist in the world to say "no, no, it's 100% safe", it still wouldn't assuage the worries of everyone.)

 

[Joeseph Stope]

I imagine a lot of it comes from a place of: "But what if it makes it worse?". There's a large pool of people with tinnitus, but a much smaller pool of people with tinnitus that is so bad that they'll take the risk of worsening just for some relief.

(Not saying that this treatment would do that; but with this condition, fear is omnipresent, and even were every scientist in the world to say "no, no, it's 100% safe", it still wouldn't assuage the worries of everyone.)

Early-onset patients in the acute phase of tinnitus are often driven by the fear that if they don't cure it quickly, it will become chronic and permanent.

But if you're already a chronic case, I suppose it's only natural to weigh things up and think, "If there's a risk of it getting much worse, can I handle it?" Things like family, kids, holding down a job, and being able to get enough sleep would all come into consideration.

 

[vttbx]

I had a call with Dr. Seidman to connect and hear about the early results from his study. Instead, he gave me a current status update: they are facing major problems recruiting patients. This is not because of serious side effects, but rather because they are not entirely sure why participation is so low.

Dr. Seidman said he would appreciate it if I shared this information online, so I am doing that here.

He believes too few people know about the trial and that the biggest barrier may be the requirement to travel to the study site once a week for 10 weeks, which is about three months. Personally, I find it hard to understand why, if you suffer from tinnitus, you would not consider that effort worthwhile.

This work is being funded with millions from the U.S. Department of Defense and could potentially help even in chronic cases. As Dr. Seidman himself said, it could help "billions of people." It would be a real shame if this funding went to waste. What message would that send? That tinnitus does not truly require treatment? That patients are not willing to commit to a weekly injection for a few months?

And what would that mean for us as a community? Most likely, the next time, the U.S. Department of Defense will not invest millions again, but instead conclude that tinnitus may not be such a pressing issue after all. That thought deeply troubles me, and I simply cannot understand how such a situation can happen.

You may want to inform Dr. Seidman that whoever is monitoring the email (tinnitustrial@wayne.edu) doesn't respond to requests for information, based on my experience.

 

[gracepixie]

He believes too few people know about the trial and that the biggest barrier may be the requirement to travel to the study site once a week for 10 weeks, which is about three months. Personally, I find it hard to understand why, if you suffer from tinnitus, you would not consider that effort worthwhile.

I have three kids and a job. My tinnitus drives me nuts, but I also have responsibilities, as most of us do. If they have that much money, they should open additional trial sites. Providing equitable access is the responsibility of the drug developer, not the patient.

 

[Joeseph Stope]

You may want to inform Dr. Seidman that whoever is monitoring the email (tinnitustrial@wayne.edu) doesn't respond to requests for information, based on my experience.

Interesting point. The drug is targeted at those with blast-induced tinnitus. It seems that army veterans would be the ones most likely to need treatment for this. Florida has no shortage of army bases, so did he advertise properly in the areas near them, as well as in veterans' hospitals?

 

[Saba]

I was called today by a woman in Florida, and I explained that I had already been declined back in March at Wayne State for the drug trial (injection). She mentioned that they are having difficulty finding participants.

If you live in Michigan and are interested, here are two contacts: Jamal at 313.577.9900 and Jackie at 313.577.1001. I believe they are affiliated with Wayne State University in Detroit, Michigan.

 

[Kam75]

Hi everyone,

Could someone please help me understand, as I'm not sure I have this right.

We have a treatment already in phase II trials that is intended to treat tinnitus in patients exposed to an explosion. Since an explosion is a sound, it could also potentially help those who developed tinnitus from acoustic trauma. Yet no one seems to care?

Why does this thread only have about fifteen messages, when the thread on FX-322 at the time had over a hundred, and even the one on Cilcare already has four pages?

What is different about this treatment compared to the others that could explain the lack of interest?

 

[DimLeb]

Hi everyone,

Could someone please help me understand, as I'm not sure I have this right.

We have a treatment already in phase II trials that is intended to treat tinnitus in patients exposed to an explosion. Since an explosion is a sound, it could also potentially help those who developed tinnitus from acoustic trauma. Yet no one seems to care?

Why does this thread only have about fifteen messages, when the thread on FX-322 at the time had over a hundred, and even the one on Cilcare already has four pages?

What is different about this treatment compared to the others that could explain the lack of interest?

Probably because the actual drug is an anti-inflammatory and is already used for some diseases. I'm guessing it's similar to trialing Prednisone or something like that, and probably not worth the hassle.

 

[Joeseph Stope]

Hi everyone,

Could someone please help me understand, as I'm not sure I have this right.

We have a treatment already in phase II trials that is intended to treat tinnitus in patients exposed to an explosion. Since an explosion is a sound, it could also potentially help those who developed tinnitus from acoustic trauma. Yet no one seems to care?

Why does this thread only have about fifteen messages, when the thread on FX-322 at the time had over a hundred, and even the one on Cilcare already has four pages?

What is different about this treatment compared to the others that could explain the lack of interest?

Well, in France, during August, the whole country goes on vacation?

 

[Kam75]

Well, in France, during August, the whole country goes on vacation?

The thread was created two months ago. So yes, if there have been so few reactions in two months, that raises questions.

 

[Mathilda]

Apparently, this is a phase II clinical trial. I couldn't find any phase I trial that tested Etanercept as a possible treatment for tinnitus.

Does anyone know why that is, or did I miss something obvious?

 

[ploughna]

My $0.02: I believe if this had a positive effect on tinnitus, we would know about it already. Enbrel has been on the market since the late 1990s with hundreds of thousands of users. Given the prevalence of tinnitus in the broader population, you would think the word would be out by now if there were any real benefit.

Speaking personally, I was on Enbrel for 10 years and developed tinnitus while I was already taking the full weekly dose. When I stopped taking it, there was no change in my tinnitus. Take that for what it's worth, but I'm not holding my breath on this one.

 

[Joeseph Stope]

Duh… can we conclude that Enbrel causes tinnitus, then? I'd say there must have been other factors involved as well. For example, prolonged negative stress, loud noise, infection, or age, which are the usual causes.

Or maybe I should be more patient with the pharmaceutical sector, since they are the ones fighting on our side.

 

[ploughna]

Duh… can we conclude that Enbrel causes tinnitus, then? I'd say there must have been other factors involved as well. For example, prolonged negative stress, loud noise, infection, or age, which are the usual causes.

Or maybe I should be more patient with the pharmaceutical sector, since they are the ones fighting on our side.

I should have been more explicit. My tinnitus is from noise exposure, no question about that. I was simply pointing out that I had tinnitus both while taking Enbrel and after stopping it, and I noticed no changes in my tinnitus.