motochondrial encephalomyopathy (MELAS)
Conditions
Interventions
Sponsors
Kawasaki Medical School Hospital
National Defense Medical College Hospital Seirei Hamamatsu General Hospital Fujita Health University School of Medicine National Hospital Organization Kyoto Medical Center Hyogo-Chuo National Hospital Fukuoka University Chikushi Hospital Nagasaki University Hospital Hiroshima University Hospital Nippon Medical School National Center of Neurology and Psychiatry Teikyo University of Science
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)MELAS patients who participated in the multiceentre trial of KN01 (KN01-MELAS-01:UMIN000011908). (2)Adult patients who agree to participate in the clinical trial and sign the written informed consent document. Children patients who cannot autonomously provide informed consent are required to give informed assent by themselves. Instead, their parents sign the written informed consent document.
Exclusion criteria
Exclusion criteria: (1) Patients can not be conducted by head MRI scan because of pacemaker implantation, etc. (2) Patients with severe coma or status epileptics (3) Patients incapable of communication due to dementia, bedridden, etc., (4) Patients with merger sepsis (5) Patients with severe impairment in cardiac, liver, or renal function (6) Patients in need of systemic administration of steroids for a long period of time (2 weeks or more) (7) Patients with pyruvate in 12 weeks before obtaining informed consent (8) Patients who are pregnant or lactating, or may be pregnant (9) Patients with history of hypersensitivity to the component of study drug (10)Ppatients with history of drug allergy (11) Patients who participated in clinical trials within 12 weeks before obtaining informed consent (12) Other, patients whom physician or investigator has determined disqualified as participants
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety: adverse events and adverse effects | — |
Countries
Japan
Contacts
Public ContactMai Moriyama
CTD inc. Medicinal Products Promotion Division
Outcome results
None listed