Phase 3 Muscular Dystrophy 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:

• People who took part in a previous clinical study of Givinostat for Duchenne Muscular Dystrophy (DMD) and completed their final study visit, OR people who were screened for a specific earlier Givinostat study (DSC/14/2357/48), met all the entry requirements for that study, had a muscle fat measurement result that placed them in an "off-target" group (either very low or very high), and were never assigned to a treatment group because that group was already full.
• People who are 6 years of age or older.
• People who are able to give written agreement to take part, either themselves or through a parent or legal guardian, as required by local rules.
• People who are willing to use reliable contraception from the time of the previous Givinostat study through to 3 months after the last dose of study medication — acceptable methods include complete abstinence (no sexual activity at all, consistent with the person's usual lifestyle) or a condom used with spermicide combined with an additional contraceptive method used by the female partner (such as a hormonal contraceptive, diaphragm, or barrier method with spermicidal jelly). Note: periodic abstinence (such as calendar or ovulation tracking methods) and withdrawal are not accepted as sufficient.

Who may not be able to join:

• People who have taken any medication (other than corticosteroids) that could affect muscle strength or function within the 3 months before enrolling — for example, growth hormone. Vitamin D, calcium, and other standard supplements are permitted.
• People who are currently taking another experimental/investigational drug other than Givinostat.
• People who have another significant health condition that, in the treating doctor's opinion, could affect their safety, make it unlikely they would complete the study, or make it harder to assess the study results.
• People who have another uncontrolled neurological condition, or another significant uncontrolled physical health condition unrelated to DMD.
• People whose blood test results at screening show that platelet count, white blood cell count, or haemoglobin are below the normal range (a repeat test will be done if the first result is abnormal; if the repeat result is also below normal, the person would not be eligible).
• People whose fasting triglyceride (blood fat) level is above 300 mg/dL at the screening visit (a repeat test will be done if the first result is above this level; if the repeat result is also above 300 mg/dL, the person would not be eligible).
• People whose kidney function test (serum Cystatin C) is more than twice the upper limit of the normal range at screening (a repeat test will be done; if it remains above this level, the person would not be eligible).
• People who have moderate to severe heart failure (classified as New York Heart Association Class III or IV) (confirm with trial site).
• People who have a current liver disease or impaired liver function, including an elevated bilirubin level more than 1.5 times the upper limit of normal — unless this is due to a specific harmless condition called Gilbert's disease.
• People who have an abnormal heart rhythm measurement (QTcF greater than 450 milliseconds on an ECG), or a personal or family history of certain heart rhythm risk factors such as low potassium levels or a condition called Long QT Syndrome.
• People who have a psychiatric illness or personal circumstances that would prevent them from understanding or completing the required muscle function tests or following the study procedures.
• People who have a known allergy or sensitivity to any ingredient in the study medication.
• People who have an inability to process sorbitol properly, or who have a hereditary condition called fructose intolerance.

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