Evaluating Possible Improvement in Tinnitus Severity After 28 Days Dosing of the Study Drug AUT00063 Compared to Placebo (QUIET-1)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02315508|
Recruitment Status : Completed
First Posted : December 12, 2014
Last Update Posted : March 31, 2016
|Condition or disease||Intervention/treatment||Phase|
|Tinnitus, Subjective||Drug: AUT00063 Drug: Placebo||Phase 2|
Reduced activity at certain sites in the brain (called "voltage-gated potassium channels") has been linked to hearing problems, like age-related loss of hearing or tinnitus (a 'ringing' or buzzing noise in the ears).
AUT00063 is an experimental new medicine that has been developed to improve the action of these specific channels and so treat the brain component of these hearing problems.
The main purpose of this study is to try to demonstrate an improvement in the severity of tinnitus after 4 weeks of treatment with the study medicine or the placebo (dummy drug which does not contain the medication). 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.) and in case of any serious medical event during the study. The amount of drug in the blood will also be measured.
It is expected that up to 152 people with tinnitus may take part in the study. The study participants will be recruited at around 16 Hospital sites in the UK.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||91 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Balanced Randomised Placebo Controlled Double-blind Phase IIa Study to Investigate the Efficacy and Safety of AUT00063 Versus Placebo in Subjective Tinnitus|
|Study Start Date :||October 2014|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
4 capsules of 200 mg of the new medicine, AUT00063, to take orally with food for 4 weeks.
800 mg orally, once a day, for 4 weeks
Other Name: Experimental
Placebo Comparator: Placebo
4 capsules of placebo, to take orally with food for 4 weeks.
orally, once a day, for 4 weeks
Other Name: Comparator
- Change in subjective Tinnitus after 4 weeks treatment [ Time Frame: 28 days ]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 ]To investigate the safety and tolerability of AUT00063 by assessing vital signs, physical examination, laboratory exams and ECG
- Change in Tinnitus Loudness matching after 4 weeks of treatment [ Time Frame: 28 days ]Changes from baseline (D1) at Day 28 between treatment groups in Tinnitus loudness matching (LM).
- Pharmacokinetic of AUT00063 (Exposure of AUT00063 ng/ml, measured as AUT00063 plasma levels) [ Time Frame: at day 28 ]Exposure of AUT00063 ng/ml, measured as AUT00063 plasma levels at Day 28
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02315508
|Birmingham University Hospital|
|Birmingham, United Kingdom, B15 2WB|
|Bradford Teaching Hospital|
|Bradford, United Kingdom, BD9 6RJ|
|Bristol Royal Infirmary|
|Bristol, United Kingdom, BS2 8HW|
|Cambridge University Hospitals NHS Trust|
|Cambridge, United Kingdom, CB2 0QQ|
|Frimley Health NHS Foundation Trust|
|Frimley, United Kingdom, GU16 7UJ|
|University College London Hospital NHS Foundation Trust|
|London, United Kingdom, WC1E 6BT|
|The Pennine Acute Hospitals NHS Trust|
|Manchester, United Kingdom, M8 5RB|
|Newcastle, United Kingdom, NE7 7DN|
|Norfolk and Norwich University Hospital Foundation Trust|
|Norwich, United Kingdom, NR4 7UY|
|Nottingham University Hospitals NHS Trust|
|Nottingham, United Kingdom, NG7 2UH|
|Derriford Plymouth NHS Trust|
|Plymouth, United Kingdom, PL6 8DH|
|Portsmouth Hospitals NHS Trust|
|Portsmouth, United Kingdom, PO6 3LY|
|Salford Royal Hospital|
|Salford, United Kingdom, M6 8HD|
|Royal Hallamshire Hospital, Sheffield|
|Sheffield, United Kingdom, S10 3BR, UK|
|Stevenage, United Kingdom, SG1 4AB|
|University Hospital of North Staffordshire|
|Stoke-on-Trent, United Kingdom, ST4 6QG|
|Shrewsbury and Telford Hospital NHS Trust|
|Telford, United Kingdom, TF1 6TF|
|Wigan, United Kingdom, WN6 9EP|
|Principal Investigator:||Jaydip Ray, MD||Sheffield Teaching Hospitals NHS Trust|