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    Summary
    EudraCT Number:2014-002179-27
    Sponsor's Protocol Code Number:AUT032063
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2014-07-14
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2014-002179-27
    A.3Full title of the trial
    A Balanced Randomised Placebo Controlled Double-blind Phase IIa Study to Investigate the Efficacy and Safety of AUT00063 Versus Placebo in Subjective Tinnitus
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study to demonstrate an improvement in tinnitus severity after 28 days dosing of the study drug AUT00063 compared to placebo, in participants with subjective tinnitus.
    A.3.2Name or abbreviated title of the trial where available
    QUIET-1
    A.4.1Sponsor's protocol code numberAUT032063
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAutifony Therapeutics Limited
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportTSB Biomedical catalyst
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAutifony Therapeutics Limited
    B.5.2Functional name of contact pointPeter Harris
    B.5.3 Address:
    B.5.3.1Street AddressImperial College
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeSW7 2AZ
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number447739 798 146
    B.5.6E-mailpeter.harris@autifony.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.2Product code AUT00063
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Subjects suffering with noise and/or age-related tinnitus
    E.1.1.1Medical condition in easily understood language
    Subjects suffering with noise and/or age-related tinnitus
    E.1.1.2Therapeutic area Diseases [C] - Ear, nose and throat diseases [C09]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    E.1.2Level LLT
    E.1.2Classification code 10042398
    E.1.2Term Subjective tinnitus
    E.1.2System Organ Class 100000004854
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate a clinically- relevant improvement in tinnitus severity after repeat dosing in subjects with subjective tinnitus
    E.2.2Secondary objectives of the trial
    • To further investigate if repeat administration of AUT00063 is safe and well tolerated;
    • To assess the effect on the different domains of tinnitus;
    • To assess the effect of repeat administration of AUT00063 on neural activity of the brain in subjects with tinnitus.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or Female, English-speaking, subjects ≥18 years of age who are UK residents registered with a UK General Practitioner
    2. Experiencing stable tinnitus (consistent from day to day) with a Tinnitus Functional Index (TFI) score of ≥24 and ≤68;
    3. Tinnitus has existed for not less than 6 months, and not more than 18 months at study start. Initially, recruitment will focus on subjects with tinnitus experienced up to 12 months prior to screening (sub-acute). However, recruitment rate will be actively monitored at weekly intervals and if it falls below target recruitment then the recruitment window will be extended up to 18 months (chronic).
    4. Sensorineural hearing loss (Pure Tone Average (of thresholds at, 500, 1000, 2000 and 4000Hz) ≥20 and ≤60dB Hearing Loss (HL));
    5. Normal Life expectancy for age of subject, as documented by the Investigator;
    6. Female subjects of childbearing potential must have a negative serum pregnancy test result at screening and a negative urine pregnancy test on the randomisation and baseline assessment visit, and practice two reliable methods of contraception throughout the study. A female is considered of childbearing potential unless she is:
    o Postmenopausal for at least 12 months prior to study drug administration;
    o Without a uterus and/or both ovaries; or
    o Has been surgically sterile for at least 6 months prior to study drug administration.
    o Reliable methods of contraception are:
     Hormonal methods or intrauterine device in use > 90 days prior to study drug administration;
     Barrier methods plus spermicide in use at least 14 days prior to study drug administration; or
     Vasectomised partner.
    7. Able to understand and comply with the requirements of the study, and sign Informed Consent forms.
    E.4Principal exclusion criteria
    1. History of hypersensitivity or idiosyncratic reaction to any component of the test medication;
    2. Any acute disabling illness;
    3. Diabetes mellitus with an HbA1C >8% (64mmol/mol);
    4. Previous cardiac rhythm disorders or ECG rhythm abnormalities whether symptomatic or not and considered clinically significant;
    5. Severe hearing impairment such that verbal communication is unreliable;
    6. 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;
    7. Moderate or severe depression or generalised anxiety as indicated by a score of ≥11 out of 21 on the Hospital Anxiety and Depression Scale (HADS) (Zigmond and Snaith 1983);
    8. Alcohol or drug abuse, deemed clinically significant by the Investigator;
    9. History of poor cooperation, non-compliance with medical treatment, or unreliability;
    10. Participation in any clinical research study evaluating another investigational drug or therapy within 30 days or at least 5 half-lives (whichever is longer), of the investigational drug prior to consenting to study entry;
    11. Participation in hearing study, involving an intervention, within 3 months from last study visit;
    12. Use of central nervous system active drugs except analgesics and those as specified in section 10.2.2
    13. Non-study treatments for the management of tinnitus, severe insomnia, major depressive disorder, severe anxiety, or post-traumatic stress disorder following baseline visit on D1; (NB counselling allowed as long as it has been implemented prior to screening visit)
    14. Central nervous system pathologies e.g. Multiple Sclerosis, Parkinson’s disease;
    15. 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);
    16. Pulsatile tinnitus (rhythmical sounds that often beat in time with the heartbeat)
    17. Intermittent tinnitus (comes and goes from one day to the next
    18. Surgery or medical condition that would be expected to significantly affect absorption of medicines;
    19. Presence or history of relevant severe adverse reaction to any drug or a history of sensitivity to potassium channel modulators;
    20. Blood pressure and heart rate (in seated position) at the screening examination outside the ranges specified;
    21. Corrected QTc interval < 330 msec at baseline in men or < 340 msec at baseline in females or > 450 msec at baseline for males and females.
    22. Clinically-relevant out of range values in any haematology, urinalysis or clinical chemistry tests.
    E.5 End points
    E.5.1Primary end point(s)
    Effect on Tinnitus severity measured as a clinically significant change from baseline in TFI overall score between AUT00063 (800 mg) and placebo at Day 28
    E.5.1.1Timepoint(s) of evaluation of this end point
    at day 28 stop of treatment
    E.5.2Secondary end point(s)
    The secondary efficacy variable will be the changes from baseline (D1) at Day 28 between treatment groups in Tinnitus loudness matching.
    Other efficacy study variables will include the following:
    • Percentage of subjects with a clinically significant change from baseline in TFI score between AUT00063 (800 mg) and placebo at on D28;
    • Visual Analogue Scale tinnitus loudness (Q2 from TFI questionnaire) at D1 and D28
    • Diary card assessment (including day to day variations);
    • CGI score;
    • LSEQ score;
    • Statistically significant difference in Changes from baseline in one or more of the eight domains that comprise the TFI for AUT00063 vs. placebo.
    . Safety Variables will include: Vital signs, physical examination findings, AEs, Laboratory data, ECG.
    • Pharmacological electroencephalography (phEEG) (at least one study site at D1 and optional D28);
    • Auditory Brainstem Response (performed by at least one site) at D1 and D28.
    . Plasma Concentration of AUT00063 ng/ml, which will be measured as AUT00063 plasma levels at Day 28.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline and day 28
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned12
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 102
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state152
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-08-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-08-29
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2015-10-08
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