Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Nottingham | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study aims to demonstrate that the new medicine AUT00063 is effective and safe in the treatment of tinnitus.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AUT00063 | Experimental | 4 capsules of 200 mg of the new medicine, AUT00063, to take orally with food for 4 weeks. |
|
| Placebo | Placebo Comparator | 4 capsules of placebo, to take orally with food for 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AUT00063 | Drug | 800 mg orally, once a day, for 4 weeks |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in subjective Tinnitus after 4 weeks treatment | To compare the change from baseline (D1 to D28) of the Tinnitus Functional Index overall score between AUT00063 (800 mg) and placebo. | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| To further investigate the safety and tolerability profile of repeat administration of AUT00063 (assessing vital signs, physical examination, laboratory exams and ECG) | To investigate the safety and tolerability of AUT00063 by assessing vital signs, physical examination, laboratory exams and ECG | 42 days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jaydip Ray, MD | Sheffield Teaching Hospitals NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham University Hospital | Birmingham | B15 2WB | United Kingdom | |||
| Bradford Teaching Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30939361 | Derived | Hall DA, Ray J, Watson J, Sharman A, Hutchison J, Harris P, Daniel M, Millar B, Large CH. A balanced randomised placebo controlled blinded phase IIa multi-centre study to investigate the efficacy and safety of AUT00063 versus placebo in subjective tinnitus: The QUIET-1 trial. Hear Res. 2019 Jun;377:153-166. doi: 10.1016/j.heares.2019.03.018. Epub 2019 Mar 27. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | orally, once a day, for 4 weeks |
|
|
| Change in Tinnitus Loudness matching after 4 weeks of treatment |
Changes from baseline (D1) at Day 28 between treatment groups in Tinnitus loudness matching (LM). |
| 28 days |
| Pharmacokinetic of AUT00063 (Exposure of AUT00063 ng/ml, measured as AUT00063 plasma levels) | Exposure of AUT00063 ng/ml, measured as AUT00063 plasma levels at Day 28 | at day 28 |
| Bradford |
| BD9 6RJ |
| United Kingdom |
| Bristol Royal Infirmary | Bristol | BS2 8HW | United Kingdom |
| Cambridge University Hospitals NHS Trust | Cambridge | CB2 0QQ | United Kingdom |
| Frimley Health NHS Foundation Trust | Frimley | GU16 7UJ | United Kingdom |
| University College London Hospital NHS Foundation Trust | London | WC1E 6BT | United Kingdom |
| The Pennine Acute Hospitals NHS Trust | Manchester | M8 5RB | United Kingdom |
| Freeman Hospital | Newcastle | NE7 7DN | United Kingdom |
| Norfolk and Norwich University Hospital Foundation Trust | Norwich | NR4 7UY | United Kingdom |
| Nottingham University Hospitals NHS Trust | Nottingham | NG7 2UH | United Kingdom |
| Derriford Plymouth NHS Trust | Plymouth | PL6 8DH | United Kingdom |
| Portsmouth Hospitals NHS Trust | Portsmouth | PO6 3LY | United Kingdom |
| Salford Royal Hospital | Salford | M6 8HD | United Kingdom |
| Royal Hallamshire Hospital, Sheffield | Sheffield | S10 3BR, UK | United Kingdom |
| Lister Hospital | Stevenage | SG1 4AB | United Kingdom |
| University Hospital of North Staffordshire | Stoke-on-Trent | ST4 6QG | United Kingdom |
| Shrewsbury and Telford Hospital NHS Trust | Telford | TF1 6TF | United Kingdom |
| Wrightington Hospital | Wigan | WN6 9EP | United Kingdom |
| ID | Term |
|---|---|
| D014012 | Tinnitus |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000631987 | AUT00063 |
Not provided
Not provided
Not provided