Evaluating Possible Improvement in Tinnitus Severity After 28 Days Dosing of the Study Drug AUT00063 Compared to Placebo (QUIET-1)

March 30, 2016 updated by: Autifony Therapeutics Limited

A Balanced Randomised Placebo Controlled Double-blind Phase IIa Study to Investigate the Efficacy and Safety of AUT00063 Versus Placebo in Subjective Tinnitus

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

91

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Birmingham, United Kingdom, B15 2WB
        • Birmingham University Hospital
      • Bradford, United Kingdom, BD9 6RJ
        • Bradford Teaching Hospital
      • Bristol, United Kingdom, BS2 8HW
        • Bristol Royal Infirmary
      • Cambridge, United Kingdom, CB2 0QQ
        • Cambridge University Hospitals NHS Trust
      • Frimley, United Kingdom, GU16 7UJ
        • Frimley Health NHS Foundation Trust
      • London, United Kingdom, WC1E 6BT
        • University College London Hospital NHS Foundation Trust
      • Manchester, United Kingdom, M8 5RB
        • The Pennine Acute Hospitals NHS Trust
      • Newcastle, United Kingdom, NE7 7DN
        • Freeman Hospital
      • Norwich, United Kingdom, NR4 7UY
        • Norfolk and Norwich University Hospital Foundation Trust
      • Nottingham, United Kingdom, NG7 2UH
        • Nottingham University Hospitals NHS Trust
      • Plymouth, United Kingdom, PL6 8DH
        • Derriford Plymouth NHS Trust
      • Portsmouth, United Kingdom, PO6 3LY
        • Portsmouth Hospitals NHS Trust
      • Salford, United Kingdom, M6 8HD
        • Salford Royal Hospital
      • Sheffield, United Kingdom, S10 3BR, UK
        • Royal Hallamshire Hospital, Sheffield
      • Stevenage, United Kingdom, SG1 4AB
        • Lister Hospital
      • Stoke-on-Trent, United Kingdom, ST4 6QG
        • University Hospital of North Staffordshire
      • Telford, United Kingdom, TF1 6TF
        • Shrewsbury and Telford Hospital NHS Trust
      • Wigan, United Kingdom, WN6 9EP
        • Wrightington Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AUT00063
4 capsules of 200 mg of the new medicine, AUT00063, to take orally with food for 4 weeks.
Drug: AUT00063
800 mg orally, once a day, for 4 weeks
Other Names:
  • Experimental
Placebo Comparator: Placebo
4 capsules of placebo, to take orally with food for 4 weeks.
Drug: Placebo
orally, once a day, for 4 weeks
Other Names:
  • Comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
28 days

Secondary Outcome Measures

Outcome Measure
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)
Time Frame: 42 days
To investigate the safety and tolerability of AUT00063 by assessing vital signs, physical examination, laboratory exams and ECG
42 days
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).
28 days
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
at day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Autifony Therapeutics Limited

Collaborators

University of Nottingham

Investigators

  • Principal Investigator: Jaydip Ray, MD, Sheffield Teaching Hospitals NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

December 9, 2014

First Submitted That Met QC Criteria

December 11, 2014

First Posted (Estimate)

December 12, 2014

Study Record Updates

Last Update Posted (Estimate)

March 31, 2016

Last Update Submitted That Met QC Criteria

March 30, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AUT032063

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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