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

• Status: Completed
• Trial end date: 2017-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Autifony Therapeutics Limited

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.