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Clinical Trial Summary

Expanded access to DCA as continued treatment for congenital lactic acidosis.


Clinical Trial Description

Subjects who participated in a Phase 3 Randomized Controlled Trial of DCA for treatment of Congenital Lactic Acidosis (CLA) are eligible to continue treatment with investigational medication DCA at the same dose of 25mg/kg/day for expanded access. Study participants must travel to the study site for bi-annual evaluation by the study investigator. Bi-annual evaluation will include an interim medical history review, physical exam, blood collection for DCA trough level, and urine pregnancy testing (if indicated). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01797276
Study type Expanded Access
Source University of Florida
Contact
Status No longer available
Phase N/A