Placebo controlled double blind randomized Phase 2 clinical trial of sodium pyruvate on lactic acidosis associated with mitochondrial disorders (Leigh syndrome)
Phase 2
- Conditions
- eigh disorders
- Registration Number
- JPRN-UMIN000025872
- 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
- 10
Inclusion Criteria
Not provided
Exclusion Criteria
1) patients who is not evaluated by this protocol of the clinical trial 2)severe unconsciousness 3)sepsis 4)renal dysfunction by eGFR lower than 60 mL/min/1.73m2 5)heart failure (EF<40%) 6)status epileptics 7)pregnant 8)allergy against the sodium pyruvate 9)enrolled to the other clinical trial 24 weeks before this trial 10)patient who cannot evaluate the muscle activity by device 11)patients who are not recommended by the doctor
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method