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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02315508
Other study ID # AUT032063
Secondary ID
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


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
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