Impaired speech understanding in users of cochlear implants MedDRA version: 19.0 Level: PT Classification code 10048812 Term: Deafness unilateral System Organ Class: 10013993 - Ear and labyrinth disorders
Conditions
Interventions
Product Name: AUT00063
Product Code: AUT00063
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: -
CAS Number: -
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Sponsors
Autifony Therapeutics Limited
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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 ;Secondary Objective: Safety and tolerability of AUT00063 will be evaluated in the study subjects.; Primary 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. ;Timepoint(s) of evaluation of this end point: Day 28 (last dose) of each period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety and tolerability.;Timepoint(s) of evaluation of this end point: Day 1, Day 14, Day 28 of each period and 2 weeks after last dose. | — |
Countries
United Kingdom
Contacts
Public ContactClinical Project Manager
Autifony Therapeutics Limited
Outcome results
None listed