Dichloroacetate Treatment of Congenital Lactic Acidosis Phase B: Expanded Access
- Conditions
- Mitochondrial Enzyme Deficiencies
- Registration Number
- NCT01797276
- Lead Sponsor
- University of Florida
- Brief Summary
Expanded access to DCA as continued treatment for congenital lactic acidosis.
- Detailed 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).
Recruitment & Eligibility
- Status
- NO_LONGER_AVAILABLE
- Sex
- Female
- Target Recruitment
- Not specified
Inclusion Criteria
- Diagnosis of congenital lactic acidosis
- Participation in Study: #183-1992: Dichloroacetate Treatment of Congenital Lactic Acidosis
Exclusion Criteria
- Intolerance to DCA
Study & Design
- Study Type
- EXPANDED_ACCESS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Florida Box 100226
🇺🇸Gainesville, Florida, United States