QuicK+fire-P study

• Research type

  Research Study

• Full title

  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

• IRAS ID

  199027

• Contact name

  Shakeel Saeed

• Contact email

  shakeel.saeed@ucl.ac.uk

• Sponsor organisation

  Autifony Therapeutics Limited

• Eudract number

  2015-003929-34

• Duration of Study in the UK

  0 years, 10 months, 0 days

• Research summary

  A Phase IIa, multi-centre, double-blind Placebo-controlled Crossover Study to Explore the Possible Benefit of AUT00063, in Adult Post-lingual Unilateral Cochlear Implant Recipients.

  The purpose 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 (CI) users.
  The study will also explore the effects of repeat doses of AUT00063 on parameters of central auditory processing measured using tests that involve direct stimulation via the CI.

  A total of approximately 20 patients will participate in this study at approximately 4 sites throughout UK.

  Participants will be randomised in a 1:1 ratio to receive either AUT00063 800 mg/day or matched placebo for 28 days, followed by a 2 to 4 week washout period before commencing the second 28-day dosing period with the other medication. Study duration for each participant is expected to be 12 to 19 weeks.

  Participants would be asked to sign a consent form and would be screened to determine their eligibility to take part in the study.
  Only participants with impaired speech understanding in users of cochlear implants and meet other inclusion criteria would be eligible for this study.

  Some of the procedures/assessments that the participants would undergo are:

  • The screening examination will include a medical history, a brief physical examination, electrocardiogram (ECG) (a heart recording test), a speech recognition test, and questionnaires about anxiety and depression and participant’s experience with tinnitus

  • Vital signs (temperature, breathing rate, blood pressure and heart rate) will be measured at each visit.

  • Blood and Urine samples will be collected for sampling

  • Standard audiology tests will be performed and participants ears will be examined by a qualified audiologist
  • Speech recognition tests will be performed to measure participants ability to hear when background noise is present

  It is possible that participants taking part in this study may find no benefit to them, but the information obtained from this study will help in future to improve the treatment of people with impaired speech understanding in users of cochlear implants.

  Autifony Therapeutics Limited is sponsor of the study.

• REC name

  South Central - Berkshire Research Ethics Committee

• REC reference

  16/SC/0076

• Date of REC Opinion

  25 Feb 2016

• REC opinion

  Favourable Opinion