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Keyword: aut00063

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  • Efficacy and Safety of AUT00063 Versus Placebo in Age-Related Hearing Loss (CLARITY-1)

    10/16/2015 12:08:57 PM PDT · by Red Badger · 40 replies
    ClinicalTrials.gov ^ | Last updated: August 17, 2015 | Autifony Therapeutics Limited
    This study is currently recruiting participants! First Received Date ICMJE January 19, 2015 Last Updated Date August 17, 2015 Start Date ICMJE January 2015 Estimated Primary Completion Date December 2015 (final data collection date for primary outcome measure) Current Primary Outcome Measures ICMJE (submitted: January 22, 2015) Change in hearing loss after 4 weeks of treatment [ Time Frame: 28 days ] [ Designated as safety issue: No ] To compare the change from baseline (Day 1 to Day 28) between AUT00063 and placebo, on a speech-in-noise deficit Original Primary Outcome Measures ICMJE Same as current Change History Complete list...
  • Evaluating Possible Improvement in Tinnitus Severity After 28 Days Dosing of the... Drug AUT00063

    10/16/2015 9:45:47 AM PDT · by Red Badger · 37 replies
    ClinicalTrials.gov ^ | Last updated: October 13, 2015 | Autifony Therapeutics Limited & University of Nottingham (UK)
    This study is ongoing, but not recruiting participants. Change in subjective Tinnitus after 4 weeks treatment [ Time Frame: 28 days ] [ Designated as safety issue: No ] To compare the change from baseline (D1 to D28) of the Tinnitus Functional Index overall score between AUT00063 (800 mg) and placebo. To further investigate the safety and tolerability profile of repeat administration of AUT00063 (assessing vital signs, physical examination, laboratory exams and ECG) [ Time Frame: 42 days ] [ Designated as safety issue: Yes ] To investigate the safety and tolerability of AUT00063 by assessing vital signs, physical examination,...