Safety Study for NST-001 and the Neuroject Injection Set to Treat Tinnitus

[Tinnitus Talk]

Tinnitus Talk submitted a new resource:

Safety Study for NST-001 and the Neuroject Injection Set to Treat Tinnitus (version 1.0) - To investigate the safety of NST-001, delivered directly to the inner ear.

This research study involves an experimental drug (NST_001) and a delivery system. The main purpose of this research study is to investigate the safety of NST-001, delivered directly to the inner ear for the treatment of tinnitus.


Estimated Enrollment: 24
Study Start Date: January 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)

Read more about this resource...

 

[nookie]

Hi,

I dont know if if the right place to place this but still i'm going ahead
There are now trials for a drug named NST-001. I don't know if some has already tried it but they are searching for people to participate in Belgium, France.

http://www.clinicaltrials.gov/ct2/show/NCT00957788?term=tinnitus&rank=53

I've found this article and to me it sounded positive.
http://www.dailymail.co.uk/health/article-1242460/Revealed-The-drug-end-misery-tinnitus.html

Any thoughts ?

 

[Fish]

Very interesting, I wonder what is the substance in NST-001. Probably also nmda antagonist to suppress excessive glutamate. The whole thing looks similar to AM-101. If only there was some other way to administer the drug other than middle ear injection

Another thing that makes me wonder is 10-year limit inclusion criteria. With AM-101 it is 3 months. I have a feeling those time limits are completely arbitrary...

EDIT: this study hasn't been updated for almost a year now, I wonder what happened.

 

[nookie]

If you ask me they can administer the drug from any point or hole they want on me as long it becomes quiet in my ears.

Now what I read somewhere they did trials before and they searched for people before who had TT maximum 1 year, and i guess they want to see if they get any success with people who have TT for longer time.

Now they must have some results since the study started 2009 and was supposed to end at december 2012.

Here is another link of the study: http://clinicaltrials.gov/ct2/show/NCT00957788
and there is an emai to contact person so maybe someone should give a try and contact them and ask them for results..

More about the company behind: http://www.neurotechreports.com/pages/tinnitus.html
I think this is the patent of the drug: http://www.faqs.org/patents/app/20120208848

Man I'm like Kojak Enjoy the reading

 

[nookie]

An update, and not good one for us who have tinnitus more then a year. Suck =(

A new drug can help ease the discomfort of tinnitus when pumped into the inner ear, according to a recent study.

A powerful new medicine, named NST-001, has proven to be effective in calming the overactive nerves in the inner ear thought to cause tinnitus. Directly pumped into the inner ear, the drug could block the production of excessive glutamate, a brain chemical, which hyperactivates nerve cells. Such hyperactivity occurs, for example, when hearing is damaged in some way, for instance by exposure to loud noise.
At the research stage

Animal research has found that when the drug was placed in the ear, it reduces the sounds of tinnitus. And in a small pilot study on human volunteers in Germany, the majority of patients given the drug reported a significant reduction of tinnitus.

Dr Ralph Holme, director of Biomedical Research at the Royal National Institute for the Deaf, says: "In recent years, there has been research into a number of drugs which aim to reduce the hyperactivity in the brain associated with tinnitus. This particular study is interesting, as it is also testing a new way of administering a drug by pumping it straight into the inner ear."
Development of a pump

Studies have however also shown that the effect of the drug is only present during the treatment. After which, the tinnitus returns to the previous levels. The researchers are therefore focused on developing a fully integrated drug pump. The pump must have an internal reservoir that will administer the drug for more than a year, after which it will be refilled through the skin via a minor surgical procedure.

This new treatment is primarily meant for patients who have had tinnitus for less than a year, as the treatment must act during the phase when the tinnitus is still only linked to disorders in the internal ear. As of yet, it is unknown whether it will work in well-established tinnitus.

 

[Aisling]

Why does the clinical trial for this drug state that you must be deaf to be included?

 

[christy]

I read something that said clinical trials were stopped. But that article was from 2009. Is this available in the US? I guess I will make (yet another) appointment with my ENT and ask him. *Sigh*

 

[jazz]

@christy

NeuroSystec was developing this treatment; unfortunately, the company is no longer in existence. For further information see another TT post:https://www.tinnitustalk.com/threads/research-and-markets-tinnitus-pipeline-review-h1-2013.1616/

 

[t-man]

Honestly, don't put any hope into a medication helping us chronic suffered, at all.

I'd put more faith in new treatments involving tampering with brain plasticity. And this new form of treatment looks every promising with two electrical stimulus devices on the way.

 

[Dubbyaman]

Anyone know whatever happened with this idea?

http://www.dailymail.co.uk/health/article-1242460/Revealed-The-drug-end-misery-tinnitus.html

 

[James White]

Anyone know whatever happened with this idea?

http://www.dailymail.co.uk/health/article-1242460/Revealed-The-drug-end-misery-tinnitus.html

NeuroSystec has been bought by Otonomy i think, more info here : https://www.tinnitustalk.com/thread...5-for-tinnitus-—-no-limit-on-your-onset.6365/

 

[nills]

the clinical trial says

Criteria
Inclusion Criteria:

• Patients able to provide voluntary consent.
• Severe tinnitus in one ear that began no more than ten years ago.
• Ear to be treated must be deaf or have profound hearing loss.
• Subjects with cardiac disease or hypertension, must have stable disease for at least 6 months.
• Subject must have intact cochlear nerve on the ear to be treated.
• Women of childbearing potential

 

[Goldilocks]

Does anyone know what happened to this NST-001 drug?

 

[Champ]

Seriously, nothing?

 

[beeeep]

Seriously, nothing?

See the post of @James White above. Otonomy has taken over the research, and this is probably OTO-311.

Otonomy Press Release

OTO-311 is a sustained-exposure formulation of the potent and selective N-Methyl-D-Aspartate (NMDA) receptor antagonist gacyclidine. Clinical studies, including pilot studies conducted with gacyclidine, support the use of NMDA receptor antagonists as potential treatments for tinnitus. In 2013, Otonomy acquired certain assets and rights to intellectual property related to the use of gacyclidine for the treatment of tinnitus from an affiliate of NeuroSystec Corporation, a company founded by serial entrepreneur Alfred Mann.

 

[Frédéric]

Just to recall the reference of the clinical trial:
https://clinicaltrials.gov/ct2/show/NCT00957788
Status: this study has been terminated.
Estimated Study Completion Date: May 2013

I remember I sent an e-mail on December the 12th 2014 to Docteur Bruno FRACHET from the Avicenne Hospital in France who was the principal investigator of this trial to ask for the results, but he did not reply me. On the other hand, the website of Neurosystec corporation, the sponsor of this trial, does not exist anymore.