Dichloroacetate Treatment of Congenital Lactic Acidosis Phase B: Expanded Access

N/ANo Longer AvailableNCT01797276

University of Florida

Overview

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

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 Type

EXPANDED_ACCESS

Conditions

Mitochondrial Enzyme Deficiencies

Interventions

DichloroacetateDRUG

Subjects are given DCA 25mg/kg in a divided dose twice a day.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of congenital lactic acidosis * Participation in Study: #183-1992: Dichloroacetate Treatment of Congenital Lactic Acidosis Exclusion Criteria: * Intolerance to DCA

Locations (1)

University of Florida Box 100226

Gainesville, Florida, United States

Data from ClinicalTrials.gov

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