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

NCT02832128 | Completed Phase 2

• 2 other identifiers: AUT0420632015-003929-34
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 4

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.

Conditions

Hearing Loss; Hearing Impairment

Keywords

Cochlear Implant

Outcome Measures

Primary Outcomes (1)

• Speech recognition tests

  To compare % scores on a battery of speech tests after 28 days of AUT00063 compared to baseline and placebo

  10 - 12 weeks

Secondary Outcomes (2)

• Direct stimulation tests

  10 - 12 weeks

• To further investigate the safety and tolerability profile of repeat administration of AUT00063

  up to 15 weeks

Study Arms (2)

AUT00063 - Placebo

EXPERIMENTAL

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; Drug: Placebo

Placebo - AUT00063

EXPERIMENTAL

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; Drug: Placebo

Interventions

AUT00063 DRUG

4 capsules of 200 mg AUT00063, to take orally with food for 4 weeks

AUT00063 - Placebo; Placebo - AUT00063

Placebo DRUG

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

AUT00063 - Placebo; Placebo - AUT00063

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Autifony Therapeutics Limited: lead

Study Sites (4)

University Hospitals Birmingham NHS Foundation Trust

Birmingham, United Kingdom

Location

Cambridge University Hospitals NHS Foundation Trust

Cambridge, United Kingdom

Location

Royal National Throat, Nose and Ear Hospital

London, United Kingdom

Location

Manchester Royal Infirmary

Manchester, United Kingdom

Location

MeSH Terms

Conditions

Hearing Loss

Interventions

AUT00063

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Shakeel R Saeed, MD, FRCS (ORL)

  Royal National Throat, Nose and Ear Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2016
• First Posted: July 14, 2016
• Study Start: May 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: May 24, 2017

Record last verified: 2017-05

Locations

GB (4)