Back to resultsEvaluating Possible Improvement in Speech and Hearing Tests After 28 Days of Dosing of the Study Drug AUT00063 Compared to Placebo (QuicKfire)
Primary Purpose
Hearing Loss, Hearing Impairment
Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
AUT00063
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hearing Loss focused on measuring Cochlear Implant
Eligibility Criteria
Inclusion Criteria:
- Male or female aged ≥ 18 years.
- Native English speaking.
- Received a unilateral cochlear implant within the last 9 to 48 months for post-lingual deafness.
- Less than optimal speech perception at the time of enrolment (defined as a score of 25% to 95% for Bamford-Kowal-Bench (BKB) sentences.
- Fully trained and optimised at the time of enrolment.
- CI device working satisfactorily and no interventions in the 4 weeks prior to the first dose of study medication.
- Signed and dated informed consent.
Exclusion Criteria:
- Not able to understand and comply with the requirements of the study.
- CI undertaken primarily for the management of severe tinnitus.
- Moderate or severe depression or generalised anxiety.
- Currently taking or planning to take medications that are prohibited by the study protocol.
- History of important cardiac, endocrine, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic, or other major diseases deemed clinically significant.
- Clinically significant ECG abnormality or prolonged QT interval.
- Screening laboratory safety test results outside the normal ranges that are deemed to be clinically significant by the investigator.
- Any acute disabling illness.
- Clinically significant alcohol or drug abuse.
- 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.
- For women: Pregnant or nursing.
- For men and women: Not willing or able to use adequate methods of contraception.
Sites / Locations
- University Hospitals Birmingham NHS Foundation Trust
- Cambridge University Hospitals NHS Foundation Trust
- Royal National Throat, Nose and Ear Hospital
- Manchester Royal Infirmary
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
AUT00063 - Placebo
Placebo - AUT00063
Arm Description
AUT00063 (800 mg/day) for 28 days, followed by a 2 to 4 week washout period before commencing the second 28-day dosing period with placebo
Placebo for 28 days, followed by a 2 to 4 week washout period before commencing the second 28-day dosing period with AUT00063 (800 mg/day)
Outcomes
Primary Outcome Measures
Speech recognition tests
To compare % scores on a battery of speech tests after 28 days of AUT00063 compared to baseline and placebo
Secondary Outcome Measures
Direct stimulation tests
To compare rate discrimination and gap detection thresholds after 28 days of AUT00063 compared to baseline and placebo
To further investigate the safety and tolerability profile of repeat administration of AUT00063
To investigate the safety and tolerability of AUT00063 by assessing vital signs, physical examination, laboratory exams and ECG
Full Information
NCT ID
NCT02832128
First Posted
April 4, 2016
Last Updated
May 23, 2017
Sponsor
Autifony Therapeutics Limited
1. Study Identification
Unique Protocol Identification Number
NCT02832128
Brief Title
Evaluating Possible Improvement in Speech and Hearing Tests After 28 Days of Dosing of the Study Drug AUT00063 Compared to Placebo (QuicKfire)
Official Title
A Pilot Double Blind Placebo Controlled Crossover Study to Explore Possible Benefits of AUT00063, An Oral Modulator of Voltage - Gated Potassium Channels , In Adults Post-lingual Unilateral Cochlear Implant Recipients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
April 2017 (Actual)
Study Completion Date
April 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Autifony Therapeutics Limited
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this pilot study is to explore whether repeat doses of AUT00063 can provide an indication of improvement in performance of tests across a battery of speech and hearing assessments in cochlear implant users.
Detailed Description
Reduced activity at certain sites in the brain called "voltage-gated potassium channels", has been linked to hearing problems. The study drug, AUT00063, has been developed to help improve the recognition of speech by aiming to improve the action of the voltage-gated potassium channels in the hearing pathways in the brain and so help to treat the hearing problem.
The main purpose of this study is to find out whether AUT00063 can improve the understanding of speech after 28 days of treatment compared with a placebo (dummy drug which does not contain the study drug) in patients who have received a cochlear implant (CI) for post-lingual deafness.
Efficacy will be investigated through a number of assessments including speech recognition testing, parameters of central auditory processing measured using tests that involve direct stimulation via the CI, and questionnaires.
Safety assessments will also be conducted throughout the study including physical examinations, ECGs and blood sampling.
It is planned that up to 20 people who have received a cochlear implant within the last 9 to 36 months will take part in the study. The people will be recruited from around 4 hospital sites in the UK.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Hearing Impairment
Keywords
Cochlear Implant
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AUT00063 - Placebo
Arm Type
Experimental
Arm Description
AUT00063 (800 mg/day) for 28 days, followed by a 2 to 4 week washout period before commencing the second 28-day dosing period with placebo
Arm Title
Placebo - AUT00063
Arm Type
Experimental
Arm Description
Placebo for 28 days, followed by a 2 to 4 week washout period before commencing the second 28-day dosing period with AUT00063 (800 mg/day)
Intervention Type
Drug
Intervention Name(s)
AUT00063
Intervention Description
4 capsules of 200 mg AUT00063, to take orally with food for 4 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
4 capsules of placebo, to take orally with food for 4 weeks
Primary Outcome Measure Information:
Title
Speech recognition tests
Description
To compare % scores on a battery of speech tests after 28 days of AUT00063 compared to baseline and placebo
Time Frame
10 - 12 weeks
Secondary Outcome Measure Information:
Title
Direct stimulation tests
Description
To compare rate discrimination and gap detection thresholds after 28 days of AUT00063 compared to baseline and placebo
Time Frame
10 - 12 weeks
Title
To further investigate the safety and tolerability profile of repeat administration of AUT00063
Description
To investigate the safety and tolerability of AUT00063 by assessing vital signs, physical examination, laboratory exams and ECG
Time Frame
up to 15 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female aged ≥ 18 years.
Native English speaking.
Received a unilateral cochlear implant within the last 9 to 48 months for post-lingual deafness.
Less than optimal speech perception at the time of enrolment (defined as a score of 25% to 95% for Bamford-Kowal-Bench (BKB) sentences.
Fully trained and optimised at the time of enrolment.
CI device working satisfactorily and no interventions in the 4 weeks prior to the first dose of study medication.
Signed and dated informed consent.
Exclusion Criteria:
Not able to understand and comply with the requirements of the study.
CI undertaken primarily for the management of severe tinnitus.
Moderate or severe depression or generalised anxiety.
Currently taking or planning to take medications that are prohibited by the study protocol.
History of important cardiac, endocrine, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic, or other major diseases deemed clinically significant.
Clinically significant ECG abnormality or prolonged QT interval.
Screening laboratory safety test results outside the normal ranges that are deemed to be clinically significant by the investigator.
Any acute disabling illness.
Clinically significant alcohol or drug abuse.
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.
For women: Pregnant or nursing.
For men and women: Not willing or able to use adequate methods of contraception.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shakeel R Saeed, MD, FRCS (ORL)
Organizational Affiliation
Royal National Throat, Nose and Ear Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals Birmingham NHS Foundation Trust
City
Birmingham
Country
United Kingdom
Facility Name
Cambridge University Hospitals NHS Foundation Trust
City
Cambridge
Country
United Kingdom
Facility Name
Royal National Throat, Nose and Ear Hospital
City
London
Country
United Kingdom
Facility Name
Manchester Royal Infirmary
City
Manchester
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Evaluating Possible Improvement in Speech and Hearing Tests After 28 Days of Dosing of the Study Drug AUT00063 Compared to Placebo (QuicKfire)
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