Exploratory Clinical Trial of EPI-743 in Japanese MELAS Syndrome Patients - EPI-743 Therapy for Japanese MELAS

ational Center of Neurology and Psychiatry, Japan0 个研究点目标入组 10 人开始时间: 2013年5月23日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•1) Patients for whom the MELAS syndrome genetic mutation has not been confirmed 2) Patients who cannot undergo magnetic resonance spectroscopy (MRS) 3) Patients allergic to EPI-743 or to sesame oil 4) Patients with a bleeding tendency, or with abnormal PT/PTT values (INR 1.5 or higher) 5) Patients with AST or ALT values of more than double the institutional limit 6) Patients with renal failure and who require dialysis 7) Patients with fat malabsorption syndrome that impedes drug absorption 8) Patients with pyruvate dehydrogenase (PDH) deficiency or other inborn error of metabolism 9) Patients who are pregnant or planning to become pregnant 10) Patients with an alcohol dependency or who are illegal drug users 11) Patients with severe heart failure accompanied by lactate acidosis 12) Patients who have received another trial drug or test drug within three months of the start of dosing of the test drug in this trial 13) Patients with a history of severe drug hypersensitivity 14) Other patients deemed by the researchers to be unsuitable for this trial

发起方

ational Center of Neurology and Psychiatry, Japan