Posted on 10/16/2015 9:45:47 AM PDT by Red Badger
This study is ongoing, but not recruiting participants.
Change in subjective Tinnitus after 4 weeks treatment [ Time Frame: 28 days ] [ Designated as safety issue: No ] To compare the change from baseline (D1 to D28) of the Tinnitus Functional Index overall score between AUT00063 (800 mg) and placebo.
To further investigate the safety and tolerability profile of repeat administration of AUT00063 (assessing vital signs, physical examination, laboratory exams and ECG) [ Time Frame: 42 days ] [ Designated as safety issue: Yes ] To investigate the safety and tolerability of AUT00063 by assessing vital signs, physical examination, laboratory exams and ECG Change in Tinnitus Loudness matching after 4 weeks of treatment [ Time Frame: 28 days ] [ Designated as safety issue: No ] Changes from baseline (D1) at Day 28 between treatment groups in Tinnitus loudness matching (LM). Pharmacokinetic of AUT00063 (Exposure of AUT00063 ng/ml, measured as AUT00063 plasma levels) [ Time Frame: at day 28 ] [ Designated as safety issue: No ] Exposure of AUT00063 ng/ml, measured as AUT00063 plasma levels at Day 28
Evaluating Possible Improvement in Tinnitus Severity After 28 Days Dosing of the Study Drug AUT00063 Compared to Placebo Official Title ICMJE A Balanced Randomised Placebo Controlled Double-blind Phase IIa Study to Investigate the Efficacy and Safety of AUT00063 Versus Placebo in Subjective Tinnitus Brief Summary
This study aims to demonstrate that the new medicine AUT00063 is effective and safe in the treatment of tinnitus. Detailed Description
Reduced activity at certain sites in the brain (called "voltage-gated potassium channels") has been linked to hearing problems, like age-related loss of hearing or tinnitus (a 'ringing' or buzzing noise in the ears).
AUT00063 is an experimental new medicine that has been developed to improve the action of these specific channels and so treat the brain component of these hearing problems.
The main purpose of this study is to try to demonstrate an improvement in the severity of tinnitus after 4 weeks of treatment with the study medicine or the placebo (dummy drug which does not contain the medication). Subjects will undergo a safety follow-up after the treatment period.
Safety and efficacy will be determined by looking at a number of assessments (physical examinations, blood sampling, hearing assessments, questionnaires, etc.) and in case of any serious medical event during the study. The amount of drug in the blood will also be measured.
It is expected that up to 152 people with tinnitus may take part in the study. The study participants will be recruited at around 16 Hospital sites in the UK. Study Type ICMJE Interventional Study Phase Phase 2 Study Design ICMJE Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment Condition ICMJE Tinnitus, Subjective Intervention ICMJE
Drug: AUT00063 800 mg orally, once a day, for 4 weeks Other Name: Experimental Drug: Placebo orally, once a day, for 4 weeks Other Name: Comparator
Study Arm (s)
Experimental: AUT00063 4 capsules of 200 mg of the new medicine, AUT00063, to take orally with food for 4 weeks. Intervention: Drug: AUT00063 Placebo Comparator: Placebo 4 capsules of placebo, to take orally with food for 4 weeks. Intervention: Drug: Placebo
THREE RINGY DINGIES!......................HOPE FOR THIS NEW DRUG!
Estimated Enrollment ICMJE 150
Estimated Completion Date February 2016
Estimated Primary Completion Date December 2015 (final data collection date for primary outcome measure)
Can you hear me now?
Hope this proves to be safe and effective.
Thanks dor posting.
Thanks for the informative pings.
Whaaaat? I’m already deaf from working on equipment whats this ringing,? I don’t hear nuttin. I’ll book mark though.
Sometimes they do depending on if the side effects are minimal and the drug is proven safe and effective.........................
You obviously do not have tinnitus, otherwise the ringing would be there even if you were actually not able to hear other sounds.
THANKS! GREAT INFO!........................
Bookmark.
Just FReepmailed the link to everyone on the Tinnitus Ring List!.....................
High quality Ginko worked for me to bring it under control. Too much salt, sugar or bananas makes it worse.
Bananas makes sense, since they are high in potassium, and this and other drugs that show promise are potassium channel blockers..................What about broccoli?................
No, I do have it. I was just trying to deny it by being Mr. Funny guy...but, it’s not really funny at all.
I am very discouraged and skeptical about finding any relief so I bookmarked it.
I’m lucky though that it mostly rings just on one side.
My audiologist turned on a program for my hearing aids that is supposed to help but, it doesn’t seem to do squat about it.
Maybe he has it set to the wrong frequency.
My high blood pressure medicine, Lisinopril, is a derivative of rattlesnake venom.............
Could I be added to your Tinnitus list too please? I’ve had it since February of last year. Every day. Only those who have it can understand.
I thought you might be interested in this article too mlizzy. I think you said one time you have it too. You might want to be on his list too but I don’t want to speak for you there.
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