Evaluating Possible Improvement in Speech and Hearing Tests After 28 Days of Dosing of the Study Drug AUT00063 Compared to Placebo (QuicKfire)

May 23, 2017 updated by: Autifony Therapeutics Limited

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Birmingham, United Kingdom
        • University Hospitals Birmingham NHS Foundation Trust
      • Cambridge, United Kingdom
        • Cambridge University Hospitals NHS Foundation Trust
      • London, United Kingdom
        • Royal National Throat, Nose and Ear Hospital
      • Manchester, United Kingdom
        • Manchester Royal Infirmary

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
10 - 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
10 - 12 weeks
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
up to 15 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Autifony Therapeutics Limited

Investigators

  • Principal Investigator: Shakeel R Saeed, MD, FRCS (ORL), Royal National Throat, Nose and Ear Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Actual)

April 1, 2017

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

April 4, 2016

First Submitted That Met QC Criteria

July 11, 2016

First Posted (Estimate)

July 14, 2016

Study Record Updates

Last Update Posted (Actual)

May 24, 2017

Last Update Submitted That Met QC Criteria

May 23, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AUT042063
  • 2015-003929-34 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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