Trials ongoing for tinitus and hearing loss

Discussion in 'Your Living Room' started by Lisa, Apr 15, 2016.

  1. Lisa

    Lisa Member

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    Mar 21, 2015
    Prob already posted , just wanted to repost anyway.

    http://www.dailymail.co.uk/health/article-2956195/Pill-stop-hearing-loss-tinnitus-tested.html
     
  2. Vicki

    Vicki Guest

    Thanks Lisa, that's interesting, I tried finding results, since it was over 1 year old, unfortunately it didn't seem to work out.
    But I appreciate you showing us this, sometimes even if something fails it leads to something positive.

    http://www.tinnitus.org.uk/autifony

    Update from Autifony Therapeutics’ QUIET-1 clinical trial
    QUIET-1 Phase II Trial of AUT00063 in tinnitus terminated due to lack of efficacy
    AUT00063 was safe and well tolerated
    Trial of AUT00063 in age-related hearing loss continuing

    Autifony Therapeutics has now completed a planned interim analysis on the QUIET-1 tinnitus clinical trial with AUT00063. This analysis was conducted to check for evidence of treatment efficacy and to ensure that there were no safety or tolerability signals. Following its review of the results from 58 subjects who have completed the QUIET-1 trial, the Independent Data Monitoring Committee recommended that Autifony terminate recruitment due to lack of efficacy. The Committee compared the outcome of the AUT00063-treated subjects with those that received placebo, and concluded that on a statistical basis it would not be possible to reach the magnitude of positive outcome needed to show improvement over the control.

    Importantly, there were no safety or tolerability issues identified with AUT00063.

    Over the coming weeks, Autifony will be conducting a full review and analysis of the data from all of the subjects that have completed the study and aims to understand the drivers of this outcome as well as to explore if any subgroups may have benefited from treatment.

    This result of the QUIET-1 study in tinnitus does not impact Autifony’s clinical trial for Age-Related Hearing Loss, the ‘CLARITY’ study, which is ongoing in the US, and which will continue as planned.

    Dr Charles Large, CEO of Autifony commented: “The lack of efficacy of AUT00063 in the QUIET-1 study is clearly disappointing news for tinnitus sufferers, and indeed for everyone who has supported Autifony in its work on this trial. Autifony is very grateful for all the help it has received in carrying out this study, from Innovate UK in terms of funding, from the charities and patient groups who are supportive of the Company’s efforts, from the Principal Investigators and Research Nurses and most of all, from the people with tinnitus who volunteered to participate in the QUIET-1 trial.”

    Treating tinnitus is a difficult challenge, with a high unmet need, and Autifony is keen to ensure that it learns as much as possible from the results of the QUIET-1 trial. Once the data have been analysed, the key findings will be published in order to support future research in this area.

    Further down on the article in the daily mail they mention that
    "Meanwhile, a drug has been shown to slow the growth of cells that can lead to hearing loss and tinnitus. U.S. researchers have shown that salicylates, a type of non-steroidal anti-inflammatory drug, prevent the development of usually benign tumours, known as vestibular schwannomas."

    A common salicylate is aspirin.
     

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