A multicentre, long-term administration study of KN01 in patients with mitochondrial encephalomyopathy(MELAS)
- Conditions
- motochondrial encephalomyopathy (MELAS)
- Registration Number
- JPRN-UMIN000015538
- Lead Sponsor
- Kawasaki Medical School Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 10
Not provided
(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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method