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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02315508
First Posted: December 12, 2014
Last Update Posted: March 31, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Nottingham
Information provided by (Responsible Party):
Autifony Therapeutics Limited
  Purpose
This study aims to demonstrate that the new medicine AUT00063 is effective and safe in the treatment of tinnitus.

Condition Intervention Phase
Tinnitus, Subjective Drug: AUT00063 Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Autifony Therapeutics Limited:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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

  • 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).

  • 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


Enrollment: 91
Study Start Date: October 2014
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Comparator

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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;
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02315508


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

Additional Information:
Responsible Party: Autifony Therapeutics Limited
ClinicalTrials.gov Identifier: NCT02315508     History of Changes
Other Study ID Numbers: AUT032063
First Submitted: December 9, 2014
First Posted: December 12, 2014
Last Update Posted: March 31, 2016
Last Verified: March 2016

Additional relevant MeSH terms:
Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms