Efficacy and Safety of AUT00063 Versus Placebo in Age-Related Hearing Loss
NCT ID: NCT02345031
Last Updated: 2018-08-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
78 participants
INTERVENTIONAL
2015-01-31
2016-06-30
Brief Summary
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Detailed Description
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AUT00063 is an experimental new medicine that enhances the action of these specific channels and so may treat the brain component of these hearing problems.
The main purpose of this study is to try to demonstrate an improvement in a speech-in-noise deficit after 4 weeks of treatment with the study drug versus the placebo (dummy drug which does not contain the drug). Subjects will undergo a safety follow-up after the treatment period.
Safety and efficacy will be determined by looking at a number of assessments (physical examinations, blood sampling, hearing assessments, questionnaires, etc.).
The amount of drug in the blood will also be measured. It is expected that around 70 people (at least 35 in each arm) with age-related hearing loss may take part in the study. The study participants will be recruited at around 13 sites in the USA.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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AUT00063 (600 mg capsules)
3 capsules of 200 mg of the investigational drug AUT00063, to take orally once daily with food for 4 weeks
AUT00063
600 mg, orally, once a day, for 4 weeks
(AUT00063 placebo capsules)
3 capsules of placebo, to take orally once daily with food for 4 weeks
Placebo
orally, once a day, for 4 weeks
Interventions
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AUT00063
600 mg, orally, once a day, for 4 weeks
Placebo
orally, once a day, for 4 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have not participated in another research study within 30-days
* If female, you must confirm to be non child bearing (post-menopausal for at least 12-months or surgically sterile)
* If male, you must confirm to use a barrier method (condom)
* Not be a professional musician
* No history of important cardiac, endocrine, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic, or other major disease deemed clinically significant by the study doctor
While you are in the study, you must:
* Follow the instructions you are given
* Come to the study centre for all visits with the study doctor or study staff
* Answer the telephone at the scheduled date and time for the 2 telephone calls
* Tell the study doctor or study staff about any changes in your health or the way you feel
* Tell the study doctor or study staff if you want to stop being in the study at any time
* Bring your Diary to each visit
* Not eat or drink anything containing Grapefruit beginning 7-days before Baseline visit (Visit 3, Day 1) until the end of the study
* Use sun screen if you plan to sunbathe
* Not use headphones or headsets at high volume
* Not use hearing aids or devices at any time during the study
50 Years
89 Years
ALL
No
Sponsors
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Autifony Therapeutics Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Robert Frisina, PhD
Role: PRINCIPAL_INVESTIGATOR
Director Global Center for Hearing and Speech Research
Locations
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Sacramento ENT
Sacramento, California, United States
Colorado ENT and Allergy
Colorado Springs, Colorado, United States
ENT Associates of South Florida
Boca Raton, Florida, United States
QPS MRA (Miami Research Associates)
Miami, Florida, United States
University of South Florida
Tampa, Florida, United States
University of Louisville
Louisville, Kentucky, United States
Mayo Clinic
Rochester, Minnesota, United States
The University of Mississippi Medical Center
Jackson, Mississippi, United States
Long Island Jewish Medical Center
New Hyde Park, New York, United States
PMG Research Inc.
Wilmington, North Carolina, United States
Piedmont Ear, Nose, & Throat Associates
Winston-Salem, North Carolina, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Jean Brown Research
Murray, Utah, United States
Countries
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Other Identifiers
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AUT022063
Identifier Type: -
Identifier Source: org_study_id
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