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

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ClinicalTrials.gov Identifier: NCT02315508
Recruitment Status : Completed
First Posted : December 12, 2014
Last Update Posted : March 31, 2016
Sponsor:
Collaborator:
University of Nottingham
Information provided by (Responsible Party):
Autifony Therapeutics Limited

December 9, 2014
December 12, 2014
March 31, 2016
October 2014
December 2015   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT02315508 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Evaluating Possible Improvement in Tinnitus Severity After 28 Days Dosing of the Study Drug AUT00063 Compared to Placebo
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.

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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Tinnitus, Subjective
  • Drug: AUT00063
    800 mg orally, once a day, for 4 weeks
    Other Name: Experimental
  • Drug: Placebo
    orally, once a day, for 4 weeks
    Other Name: Comparator
  • Experimental: AUT00063
    4 capsules of 200 mg of the new medicine, AUT00063, to take orally with food for 4 weeks.
    Intervention: Drug: AUT00063
  • Placebo Comparator: Placebo
    4 capsules of placebo, to take orally with food for 4 weeks.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
91
150
December 2015
December 2015   (Final data collection date for primary outcome measure)

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;
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT02315508
AUT032063
Yes
Not Provided
Not Provided
Autifony Therapeutics Limited
Autifony Therapeutics Limited
University of Nottingham
Principal Investigator: Jaydip Ray, MD Sheffield Teaching Hospitals NHS Trust
Autifony Therapeutics Limited
March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP