Placebo controlled double blind randomized Phase II Clinical Trial of sodium pyruvate on lactic acidosis associated with mitochondrial disorders (MELAS/MELA)
- Conditions
- MELAS/MELA
- Registration Number
- JPRN-UMIN000025772
- Lead Sponsor
- Japan Agency of Medical Research and Development
- Brief Summary
nfortunately, data obtained by the clinical trials could not prove the efficacy overall, though there are several patients with perfect improvement by clinical rating scales. After the strategy consultation to PMDA on October 18, 2018, we decided to terminate the SP project.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 15
Not provided
1) patient who has bed ridden status 2) patient who has dementic status and cannot be evaluated the JMDRS/NMDAS by medical doctor 3) patient who has uncontrolled status epileptics 4) patient who has septic status 5) patient who has renal failre, and less than 60mL/min/1.73m by eGFR 6) patient who has hypertrophic cardiomyopathy or cardiac failre 7) patient who has allergic state against sodium pyruvate 8) patient who enrolled to the other clinical trial within 6 months 9) patient who has pregnant 10) patient who is not recommended to the entry by medical doctor
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method JMDRS section 1 & 2 change at 24 weeks after the administration of sodium pyruvate
- Secondary Outcome Measures
Name Time Method MDAS section 1-3, brain lactate by MRS, GDF15 changes at 24 weeks after the administration of sodium pyruvate