Evaluating Possible Improvement in Speech and Hearing Tests After 28 Days of Dosing of the Study Drug AUT00063 Compared to Placebo (QuicKfire)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02832128 |
|
Recruitment Status :
Completed
First Posted : July 14, 2016
Last Update Posted : May 24, 2017
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hearing Loss Hearing Impairment | Drug: AUT00063 Drug: Placebo | Phase 2 |
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 (Clinical Trial) |
| Actual Enrollment : | 15 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | 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 |
| Study Start Date : | May 2016 |
| Actual Primary Completion Date : | April 2017 |
| Actual Study Completion Date : | April 2017 |
| 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 |
- 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
- 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
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02832128
| United Kingdom | |
| University Hospitals Birmingham NHS Foundation Trust | |
| Birmingham, United Kingdom | |
| Cambridge University Hospitals NHS Foundation Trust | |
| Cambridge, United Kingdom | |
| Royal National Throat, Nose and Ear Hospital | |
| London, United Kingdom | |
| Manchester Royal Infirmary | |
| Manchester, United Kingdom | |
| Principal Investigator: | Shakeel R Saeed, MD, FRCS (ORL) | Royal National Throat, Nose and Ear Hospital |
| Responsible Party: | Autifony Therapeutics Limited |
| ClinicalTrials.gov Identifier: | NCT02832128 History of Changes |
| Other Study ID Numbers: |
AUT042063 2015-003929-34 ( EudraCT Number ) |
| First Posted: | July 14, 2016 Key Record Dates |
| Last Update Posted: | May 24, 2017 |
| Last Verified: | May 2017 |
Keywords provided by Autifony Therapeutics Limited:
|
Cochlear Implant |
Additional relevant MeSH terms:
|
Hearing Loss Deafness Hearing Disorders Ear Diseases Otorhinolaryngologic Diseases |
Sensation Disorders Neurologic Manifestations Nervous System Diseases Signs and Symptoms |