Phase 3 Hearing Loss Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You are 18 years old or older, of any gender
• You have been diagnosed with a mitochondrial disease that affects multiple parts of the body
• You have a specific confirmed genetic change in your mitochondrial DNA called the m.3243A>G mutation, with test results showing it is present at a high enough level in blood, urine, cheek swab, or muscle tissue
• You have been experiencing ongoing fatigue (not caused by anything other than your mitochondrial disease) for at least 3 months, which is recorded in your medical notes, and confirmed by a fatigue questionnaire at your screening visit
• You are able to perform a specific physical test called the "5 Times Sit to Stand" test — meaning you can stand up and sit down 5 times, completing the task in 30 seconds or less, but taking at least 11 seconds to do so
• You have agreed to take part by signing a consent form

Who may not be able to join:

• You have taken part in another clinical drug trial within the last 3 months (or longer, depending on the drug), or plan to during this study
• You have bone, movement, or wound problems that could affect your ability to do the sit-to-stand test
• You have had surgery on your digestive system, or have serious ongoing digestive problems such as severe vomiting, diarrhoea, or bowel blockages that could stop the study drug from being absorbed properly
• You have significant breathing or heart problems, based on your medical history or current health
• You have had a heart procedure (such as a stent or catheterisation) within the last 3 months
• Your heart's electrical activity (measured by an ECG) shows certain abnormal readings related to heart rhythm (confirm with trial site)
• You have structural heart problems, reduced heart pumping ability, or thickening of the heart muscle that is not well controlled (confirm with trial site)
• You or close family members have a history of unexplained fainting, a condition called long or short QT syndrome, or sudden death under age 60
• Your ECG shows signs of a recent heart attack, irregular heart rhythm (atrial fibrillation), or certain types of heart conduction problems
• You have had acute heart failure in the last 3 months
• You have certain types of heart conduction blocks (second or third degree AV block) (confirm with trial site)
• There may be additional criteria not listed here set out in the full study protocol (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.