Comparison of Single Versus Repeat Doses of AM-101 in the Treatment of Acute Inner Ear Tinnitus

[Tinnitus Talk]

Tinnitus Talk submitted a new resource:

Comparison of Single Versus Repeat Doses of AM-101 in the Treatment of Acute Inner Ear Tinnitus (version 1.0) - To evaluate the therapeutic benefit and safety of intratympanic AM-101 injections.

The purpose of the study is to evaluate the therapeutic benefit and safety of intratympanic AM-101 injections in comparison to placebo in the treatment of persistent acute inner ear tinnitus.


Estimated Enrollment: 72
Study Start Date: February 2011
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)

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[Marius T]

Where are the results please?

 

[Frédéric]

Just to recall the reference of the trial:
https://clinicaltrials.gov/ct2/show/NCT01270282
Status: this study has been completed (logic since it was the phase 2).

The results were conclusive:
http://www.aurismedical.com/images/auris/downloads/auris_factsheet_AM101.pdf
http://journals.lww.com/otology-neu...d_Safety_of_AM_101_in_the_Treatment_of.4.aspx

Since then phase 3 started. See the thread:
https://www.tinnitustalk.com/threads/am-101-in-the-treatment-of-acute-tinnitus-tactt3.3234/