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

NCT02315508 | Completed Phase 2 DMC

• 1 other identifier: AUT032063
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 18

Brief Summary

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

Conditions

Tinnitus, Subjective

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• To further investigate the safety and tolerability profile of repeat administration of AUT00063 (assessing vital signs, physical examination, laboratory exams and ECG)

  42 days

• Change in Tinnitus Loudness matching after 4 weeks of treatment

  28 days

• Pharmacokinetic of AUT00063 (Exposure of AUT00063 ng/ml, measured as AUT00063 plasma levels)

  at day 28

Study Arms (2)

AUT00063

EXPERIMENTAL

4 capsules of 200 mg of the new medicine, AUT00063, to take orally with food for 4 weeks.

Drug: AUT00063

Placebo

PLACEBO COMPARATOR

4 capsules of placebo, to take orally with food for 4 weeks.

Drug: Placebo

Interventions

AUT00063 DRUG

800 mg orally, once a day, for 4 weeks

Also known as: Experimental

AUT00063

Placebo DRUG

orally, once a day, for 4 weeks

Also known as: Comparator

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Autifony Therapeutics Limited: lead
• University of Nottingham: collaborator

Study Sites (18)

Birmingham University Hospital

Birmingham, B15 2WB, United Kingdom

Location

Bradford Teaching Hospital

Bradford, BD9 6RJ, United Kingdom

Location

Bristol Royal Infirmary

Bristol, BS2 8HW, United Kingdom

Location

Cambridge University Hospitals NHS Trust

Cambridge, CB2 0QQ, United Kingdom

Location

Frimley Health NHS Foundation Trust

Frimley, GU16 7UJ, United Kingdom

Location

University College London Hospital NHS Foundation Trust

London, WC1E 6BT, United Kingdom

Location

The Pennine Acute Hospitals NHS Trust

Manchester, M8 5RB, United Kingdom

Location

Freeman Hospital

Newcastle, NE7 7DN, United Kingdom

Location

Norfolk and Norwich University Hospital Foundation Trust

Norwich, NR4 7UY, United Kingdom

Location

Nottingham University Hospitals NHS Trust

Nottingham, NG7 2UH, United Kingdom

Location

Derriford Plymouth NHS Trust

Plymouth, PL6 8DH, United Kingdom

Location

Portsmouth Hospitals NHS Trust

Portsmouth, PO6 3LY, United Kingdom

Location

Salford Royal Hospital

Salford, M6 8HD, United Kingdom

Location

Royal Hallamshire Hospital, Sheffield

Sheffield, S10 3BR, UK, United Kingdom

Location

Lister Hospital

Stevenage, SG1 4AB, United Kingdom

Location

University Hospital of North Staffordshire

Stoke-on-Trent, ST4 6QG, United Kingdom

Location

Shrewsbury and Telford Hospital NHS Trust

Telford, TF1 6TF, United Kingdom

Location

Wrightington Hospital

Wigan, WN6 9EP, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 30939361 DERIVED

MeSH Terms

Conditions

Tinnitus

Interventions

AUT00063

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jaydip Ray, MD

  Sheffield Teaching Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2014
• First Posted: December 12, 2014
• Study Start: October 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: March 31, 2016

Record last verified: 2016-03

Locations

GB (18)