Cochlear Implant Add-on Clinical Trial – Frequently Asked Questions
Q. What is the QuicK+fire study?
A. The QuicK+fire study is a clinical trial to determine whether or not a new experimental drug, AUT00063, can improve hearing for people with cochlear implants, particularly discrimination of speech in a noisy background, in comparison to a placebo (dummy drug) after 4 weeks of daily treatment.
Q. What is AUT00063?
A. This a synthetic small molecule which modulates specific voltage gated potassium ion channels present on certain nerve cells important for hearing; the safety and tolerability of the molecule has been tested in a group of healthy volunteers and in two other clinical trials.
Q. Can I have some details of the drug itself, and how will it be administered during the trial?
A. AUT00063 is an orally active preparation that will be taken as 4 capsules once daily, with breakfast, each day continuously for 28 days. This drug is presented in yellow capsules each of 200mg.
Q. What are the side effects of AUT00063?
A. AUT00063 has completed initial "Phase I" safety studies in healthy volunteers. The drug was very well tolerated in young and older healthy volunteers. No serious side effects were noted during the Phase I trial. Side effects such as headache and fatigue were seen on some occasions in some subjects. In addition, AUT00063 has now also been tested in two other clinical trials: QUIET-1 for treatment of tinnitus in the UK, and CLARITY-1 for treatment of Age Related Hearing Loss in the US. The drug has now been taken by over 130 people, and has been generally well tolerated with a few side effects such as those seen in the Phase I trial (headache, fatigue) and also dizziness which resolved subsequently.
Q. What are the eligibility restrictions for the QuicK+fire study?
A. The study is recruiting subjects from the listed clinical trial sites. Subjects will have to be native English speaking, have had a unilateral cochlear implant within the last 36 months (but over 9 months ago), and have difficulty in hearing speech in noisy environments but are otherwise relatively healthy. Screening will be required to make sure that subjects meet certain eligibility criteria and the final decision on eligibility will be taken by the trial doctor. Further details of the study can also be seen on ClinicalTrials.gov
Q. What age restrictions apply to the study?
A. Subjects entering the study must be over 18 years old. Other entry and exclusion criteria can be seen on ClinicalTrials.gov
Q. Will this drug adversely affect my hearing?
A. AUT00063 has completed three clinical studies, over 130 people have taken AUT00063 including older subjects. In each of the studies, subjects completed hearing tests after taking the drug and no adverse effects on hearing were observed in any of the subjects.
Q. How soon does the drug start to work?
A. In the acute models tested pre-clinically the beneficial effect was seen quite rapidly, and we know that the effect on the nerve cells themselves is very quick. However, because of the so-called plasticity of the brain, and because the hearing loss will have been present for some time, the effects may not start to be felt until after days on the drug. It is for this reason that if somebody joins the study it is really important for them to stay right to the end of the study period.
Q. Can I expect to see an improvement in my audiogram?
A. No, we do not expect AUT00063 to improve the pure tone audiograms as the drug will not restore the damaged hair cells in the ear. However, AUT00063 is aimed at improving auditory processing in the brain, a very important aspect of hearing loss which increases with age, so hopefully could help with understanding speech against a background of noise (particularly in a reverberant environment) such as in a busy work environment or in restaurants and shopping.
Q. Are non-UK residents able to participate?
A. People who enrol in the QuicK+fire study must be resident in the UK, be registered with a GP and an existing patients of one of the participating trial sites.
If this study were to show encouraging effects of AUT00063, then other studies may follow across a broader range of people with hearing loss and across different countries.
Q. How long will the trial last?
A. Study participants will have to undertake a number of hospital and other visits over a period of 4- 5 months and this will take considerable time and commitment. It is for the long-term benefit of people with cochlear implants that the study generates high quality data; so it is very important participants stick with it to the end!
Q. If the study is successful then what would be the estimated arrival time to market?
A. It is too early to estimate. The early preclinical work looks very positive and exciting but, until we have done this next study in cochlear implant users, we have no precise knowledge of how predictive those models will be for success in the clinic. So we shall have to wait until this study finishes before we know! Clinical research just takes a long time, certainly a number of years.
Further information is also available at ClinicalTrials.gov