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    Summary
    EudraCT Number:2015-003929-34
    Sponsor's Protocol Code Number:AUT042063
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-01-14
    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 number2015-003929-34
    A.3Full title of the trial
    A Pilot Double-blind, Placebo-controlled Crossover Study to Explore the Possible Benefit of AUT00063, an Oral Modulator of Voltage-gated Potassium Channels, in Adult Post-lingual Unilateral Cochlear Implant Recipients: The QuicK+fire-study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to explore the benefits of AUT00063 in adults receiving Cochlear Implant
    A.3.2Name or abbreviated title of the trial where available
    QuicK+fire-P study
    A.4.1Sponsor's protocol code numberAUT042063
    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 supportAutifony Therapeutics Limited
    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 pointClinical Project Manager
    B.5.3 Address:
    B.5.3.1Street AddressImperial College Incubator Level 1 Bessemer Building Imperial College
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeSW7 2AZ
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44 203 763 9477
    B.5.5Fax number+44 7909 228 562
    B.5.6E-mailalice.grant@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.3.1Product nameAUT00063
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INN-
    D.3.9.1CAS number -
    D.3.9.2Current sponsor codeAUT00063
    D.3.9.3Other descriptive nameAUT00063
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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
    Impaired speech understanding in users of cochlear implants
    E.1.1.1Medical condition in easily understood language
    Post-lingual deafness
    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 19.0
    E.1.2Level PT
    E.1.2Classification code 10048812
    E.1.2Term Deafness unilateral
    E.1.2System Organ Class 10013993 - Ear and labyrinth disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial

    Main purpose is to generate data to enable a definitive study to be designed. Along with that, we aim to test central drug effects using direct stimulation. Using a small group of volunteers will enable to ensure that in the future we use outcome measures which are acceptable to the subjects and can be fitted into a realistic test schedule. The metrics from this pilot study will enable us to determine power calculations appropriate for the next study
    E.2.2Secondary objectives of the trial
    Safety and tolerability of AUT00063 will be evaluated in the study subjects.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects fulfilling the following criteria are eligible for participation in the study:
    (1) Male or female aged ≥ 18 years.
    (2) Native English speaking.
    (3) Received a unilateral cochlear implant within the last 9 to 36 months for post-lingual deafness.
    There are no restrictions regarding the encoding algorithm; subjects will have a MED-EL, Cochlear® or Advanced Bionics CI device.
    (4) Aged ≥ 18 years at the time of the CI surgery.
    (5) Fully trained and optimised at the time of enrolment.
    (6) CI device working satisfactorily and with at least 80% of electrode array functioning and mapped.
    (7) Less than optimal speech perception at the time of enrolment (defined as a score of 25% to 85% for Bamford-Kowal-Bench (BKB) sentences presented in quiet without contralateral hearing aid).
    (8) No interventions (e.g. alterations to coding/optimisation or speech therapy) in the 4 weeks prior to the first dose of study medication.
    (9) Signed and dated informed consent.
    E.4Principal exclusion criteria
    Subjects who meet one or more of the following criteria are not eligible:
    (1) Not able to understand and comply with the requirements of the study.
    (2) CI undertaken primarily for the management of severe tinnitus.
    (3) Tinnitus with a Tinnitus Handicap Inventory (THI) score >36.
    (4) 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).
    (5) Currently taking or planning to take medications that are prohibited by the study protocol; see Protocol Section 7.4.8. I.e. (1) CNS-penetrant concomitant medication for the management of severe insomnia (over-the-counter and prescribed sedatives for mild insomnia are allowed), major depressive disorder, severe anxiety, or post-traumatic stress disorder; (2) medication for the management of tinnitus; (3) CYP3A4 inhibitors (strong or moderate) and CYP3A4 inducers; and (4) CYP2C9 substrates with a narrow therapeutic range (cf. IB, Section 7).
    (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 jeopardized by entering the study; investigator’s discretion to define, with advice from the sponsor if requested.
    (7) Clinically significant ECG abnormality or prolonged QT interval.
    (8) Screening laboratory safety test results outside the normal ranges that are deemed to be clinically significant by the investigator.
    (9) History of hypersensitivity or idiosyncratic reaction to any named component of the test medication.
    (10) Any acute disabling illness.
    (11) Clinically significant alcohol or drug abuse, in the opinion of the Investigator or self-reported on intake form.
    (12) Participation in any clinical research study evaluating another investigational drug or therapy within 30 days or at least 5 half-lives of the investigational drug (whichever is longer) prior to consenting to study entry.
    (13) History of poor cooperation, non-compliance with medical treatment, or unreliability.
    (14) For women: Pregnant or nursing.
    (15) For men and women: Not willing or able to use adequate methods of contraception; i.e. male subjects who are sexually active must use a barrier method of contraception unless have undergone a vasectomy; female subjects must comply with 2 reliable methods of contraception or be of non-child-bearing potential (post-menopausal with an absence of menstrual bleeding for at least 12 months or permanently surgically sterilized). See also Protocol Section 7.4.11, Diet, prohibitions, and other instructions for subjects
    E.5 End points
    E.5.1Primary end point(s)
    Indication of improvement in speech tests and auditory processing after repeat dosing of IMP.
    Variability and sensitivity of the measures on the various assessments in order to power the next study.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 28 (last dose) of each period.
    E.5.2Secondary end point(s)
    Safety and tolerability.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 1, Day 14, Day 28 of each period and 2 weeks after last dose.
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    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 Yes
    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 concerned4
    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 No
    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
    LSLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 0
    F.4.2.2In the whole clinical trial 12
    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)
    Not applicable in this study
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-03-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-02-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-04-10
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