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Clinical Trials/EUCTR2015-003929-34-GB
EUCTR2015-003929-34-GB
Active, not recruiting
Phase 1

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 - QuicK+fire-P study

Autifony Therapeutics Limited0 sites15 target enrollmentJanuary 14, 2016
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Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Autifony Therapeutics Limited
Enrollment
15
Status
Active, not recruiting
Last Updated
6 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 14, 2016
End Date
April 10, 2017
Last Updated
6 years ago
Study Type
Interventional clinical trial of medicinal product

Investigators

Eligibility 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.

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.

Outcomes

Primary Outcomes

Not specified

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