Evaluating Possible Improvement in Tinnitus Severity After 28 Days Dosing of the Study Drug AUT00063 Compared to Placebo

Tinnitus, Subjective Clinical Trial

— QUIET-1  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02315508
• Other study ID #: AUT032063
• Status: Completed
• Phase: Phase 2
• First received: December 9, 2014
• Last updated: March 30, 2016
• Start date: October 2014
• Est. completion date: December 2015

Study information

• Verified date: March 2016
• Source: Autifony Therapeutics Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

This study aims to demonstrate that the new medicine AUT00063 is effective and safe in the treatment of tinnitus.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• English-speaking, who are UK residents registered with a UK General Practitioner;

• Experiencing stable tinnitus (consistent from day to day)

• Tinnitus has existed for not less than 6 months, and not more than 18 months - Contraceptive methods must be used before and for at least 30 days after the stop of the study treatment.

Exclusion Criteria:

• Severe hearing impairment such that verbal communication is unreliable;

• History of important cardiac, endocrine, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic, or other major diseases deemed clinically significant at the time of the study by the Investigator and which might be jeopardised by entering the study;

• Moderate or severe depression or generalised anxiety

• Participation in any clinical research study evaluating another investigational drug or therapy within 30 days of starting the investigational treatment

• Participation in hearing study, involving an intervention, within 3 months from last study visit;

• Central nervous system pathologies e.g. Multiple Sclerosis, Parkinson's disease;

• Tinnitus as a concomitant symptom of a known otological condition (including but not limited to otitis externa, otitis media, otosclerosis, cholesteatoma, Ménière's disease or other vestibular problems, acoustic neuroma, or temporo-mandibular joint disorder);

• Pulsatile tinnitus (rhythmical sounds that often beat in time with the heartbeat);

• Intermittent tinnitus (comes and goes from one day to the next);

• Surgery or medical condition that might would be expected to significantly affect absorption of medicines;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tinnitus
• Tinnitus, Subjective

Intervention

Drug:
• AUT00063
800 mg orally, once a day, for 4 weeks
• Placebo
orally, once a day, for 4 weeks

Locations

Country	Name	City	State
United Kingdom	Birmingham University Hospital	Birmingham
United Kingdom	Bradford Teaching Hospital	Bradford
United Kingdom	Bristol Royal Infirmary	Bristol
United Kingdom	Cambridge University Hospitals NHS Trust	Cambridge
United Kingdom	Frimley Health NHS Foundation Trust	Frimley
United Kingdom	University College London Hospital NHS Foundation Trust	London
United Kingdom	The Pennine Acute Hospitals NHS Trust	Manchester
United Kingdom	Freeman Hospital	Newcastle
United Kingdom	Norfolk and Norwich University Hospital Foundation Trust	Norwich
United Kingdom	Nottingham University Hospitals NHS Trust	Nottingham
United Kingdom	Derriford Plymouth NHS Trust	Plymouth
United Kingdom	Portsmouth Hospitals NHS Trust	Portsmouth
United Kingdom	Salford Royal Hospital	Salford
United Kingdom	Royal Hallamshire Hospital, Sheffield	Sheffield
United Kingdom	Lister Hospital	Stevenage
United Kingdom	University Hospital of North Staffordshire	Stoke-on-Trent
United Kingdom	Shrewsbury and Telford Hospital NHS Trust	Telford
United Kingdom	Wrightington Hospital	Wigan

Sponsors (2)

Lead Sponsor	Collaborator
Autifony Therapeutics Limited	University of Nottingham

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes
Secondary	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	No
Secondary	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	No

External Links

•   Tinnitus Clinical Study Information