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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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ClinicalTrials.gov Identifier: NCT02832128
Recruitment Status : Completed
First Posted : July 14, 2016
Last Update Posted : May 24, 2017
Sponsor:
Information provided by (Responsible Party):
Autifony Therapeutics Limited

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hearing Loss Hearing Impairment Drug: AUT00063 Drug: Placebo Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : May 2016
Actual Primary Completion Date : April 2017
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: AUT00063 - Placebo
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
 Drug: AUT00063
4 capsules of 200 mg AUT00063, to take orally with food for 4 weeks

Drug: Placebo
4 capsules of placebo, to take orally with food for 4 weeks
Experimental: Placebo - AUT00063
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)
 Drug: AUT00063
4 capsules of 200 mg AUT00063, to take orally with food for 4 weeks

Drug: Placebo
4 capsules of placebo, to take orally with food for 4 weeks


Outcome Measures
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Primary Outcome Measures :
  1. Speech recognition tests [ Time Frame: 10 - 12 weeks ]
    To compare % scores on a battery of speech tests after 28 days of AUT00063 compared to baseline and placebo


Secondary Outcome Measures :
  1. Direct stimulation tests [ Time Frame: 10 - 12 weeks ]
    To compare rate discrimination and gap detection thresholds after 28 days of AUT00063 compared to baseline and placebo

  2. To further investigate the safety and tolerability profile of repeat administration of AUT00063 [ Time Frame: up to 15 weeks ]
    To investigate the safety and tolerability of AUT00063 by assessing vital signs, physical examination, laboratory exams and ECG


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02832128


Locations
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United Kingdom
University Hospitals Birmingham NHS Foundation Trust
Birmingham, United Kingdom
Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom
Royal National Throat, Nose and Ear Hospital
London, United Kingdom
Manchester Royal Infirmary
Manchester, United Kingdom
Sponsors and Collaborators
Autifony Therapeutics Limited
Investigators
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Principal Investigator: Shakeel R Saeed, MD, FRCS (ORL) Royal National Throat, Nose and Ear Hospital
More Information
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Responsible Party: Autifony Therapeutics Limited
ClinicalTrials.gov Identifier: NCT02832128    
Other Study ID Numbers: AUT042063
2015-003929-34 ( EudraCT Number )
First Posted: July 14, 2016    Key Record Dates
Last Update Posted: May 24, 2017
Last Verified: May 2017
Keywords provided by Autifony Therapeutics Limited:
Cochlear Implant
Additional relevant MeSH terms:
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Hearing Loss
Deafness
Hearing Disorders
Ear Diseases
 Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases