Age Related Hearing Loss: Clinical Trial – Frequently Asked Questions
Q. What is the CLARITY-1 study?
A. The CLARITY-1 study is a clinical trial to determine whether or not a new test drug, AUT00063, can reduce symptoms of Age Related Hearing Loss in comparison to a placebo (dummy drug) after 4 weeks of 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 "063" has been tested in a group of healthy volunteers but the CLARITY-1 study is the first test in people with Age Related Hearing Loss.
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 3 capsules once daily with breakfast each day continuously for 28 days. This drug is presented in yellow capsules each of 200mg. Special tests will compare hearing abilities on day 28 as compared with day 1, of taking "063".
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 adverse effects were noted during the Phase I trial. Various minor events such as headache and fatigue were seen in some subjects on study.
Q. How do I know whether or not I am eligible to take part in the CLARITY study?
A. If you are 50 to 89 years old, your mother-tongue is American English, and you have difficulty in hearing speech in noisy environments but are otherwise relatively healthy, you may be eligible to take part. Screening will be required to make sure that you meet certain eligibility criteria and the final decision on study enrolment will be taken by the trial doctor. Further details of the study can also be seen on ClinicalTrials.gov
Q. Who should I contact to find out more about enrolment in the CLARITY study?
A. The CLARITY-1 study will be conducted at a number of sites in the US. More information on the open sites can be found here, along with contact details. This website will be updated periodically to list more sites that are involved in the clinical trial as they open for recruitment. States where sites will be opening include: MN, TN, MS, NY, OR, KY, NC, CO and perhaps others.
What age restrictions apply to the study?
Subjects entering the study must be between 50 and 89 years old (inclusive). Other entry and exclusion criteria can be seen on ClinicalTrials.gov
Can a subject with hearing loss in only 1 ear still take part?
We are looking for subjects who have hearing loss in both ears, although one ear may be slightly worse than the other; your hearing loss will be checked by the audiologist before entry into the study.
Will this drug adversely affect my hearing?
AUT00063 has completed initial “Phase I” safety studies in healthy volunteers including older subjects. No adverse effects of the drug on measures of hearing were observed in any of the subjects.
How soon does the drug start to work?
We cannot really be sure. 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 or even a week or more on the drug; perhaps even longer. It is for this reason that if somebody joins the study it is really important for them to stay right to the end.
Why are some sites doing EEG and what is this for?
By enabling the analysis of certain electrical activity of the brain, phEEG will help to confirm that the test drug is reaching the target area of the brain; we did this in our first clinical safety study and know this is a good indicator. Only one site will be doing phEEG as it is really just a double check on a small number of subjects.
Can I expect to see an improvement in my audiogram?
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, "063" is aimed at improving auditory processing in the brain, a very important aspect of Age Related Hearing Loss, 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.
Are non-US residents able to participate?
Not this time. People who enroll in the CLARITY study must be resident in the US. If this study were to show encouraging effects of AUT00063 (and we are a very considerable long way off showing anything at all at the moment, as it is only just starting) then other studies may follow across a broader range of people with hearing loss and across different countries.
It is also important to know that the study participants will have to undertake a number of hospital visits over a period of 8-10 weeks and this will take considerable time and commitment. It is for the long-term benefit of people with Age Related Hearing Loss that the study generates high quality data; if you start on the study, we really need you to stick with it to the end!
If the study is successful then what would be the estimated arrival time to market?
It is too early to estimate. The early preclinical work looks very positive and exciting but, until we have done this next study in Age Related Hearing Loss sufferers, 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