AM-101 in the Treatment of Acute Tinnitus (TACTT2)

[Tinnitus Talk]

Tinnitus Talk submitted a new resource:

Treatment of Acute Peripheral Tinnitus Following Traumatic Cochlear Injury or Otitis Media (TACTT2) (version 1.0) - To confirm the efficacy and safety of AM-101 in the treatment of peripheral tinnitus.

This phase III study is being conducted to confirm the efficacy and safety of AM-101 in the treatment of peripheral tinnitus in the acute stage (up to 3 months from onset).

TACTT2 (US, CA, CZ, KR, TR, IL):
Tinnitus onset no longer than 3 months prior to randomization
Estimated Enrollment: 330
Study Start Date: February 2014
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)

Read more about this resource...

 

[Hudson]

It looks like the start date for this has been pushed off until December 2013 with a completion date of June of 2015. I wonder why it was postponed? Supply issues? Finding study locations that will work with Auris?

 

[James White]

I guess it can be hard to find patients too

 

[Hudson]

..... and this has been delayed yet again, until January now. I wonder what is up with all the delays.

 

[NeoM]

If they keep pushing it back I'll end up being in post acute instead of acute. However, from what I understand they were just approved on the 4th of November for phase III, so maybe everything wasn't in order yet.

 

[Frédéric]

Just to recall the reference of this clinical trial:
https://clinicaltrials.gov/ct2/show/NCT01803646
Status: this study has been completed.

Follow the link below to see the results:
http://ir.aurismedical.com/phoenix.zhtml?c=253572&p=irol-newsArticle&ID=2196144

For further information, see also this thread:
https://www.tinnitustalk.com/threads/am-101-clinical-trial-—-participants-updates-and-discussion.6558/