drugset / Trial / NCT00004490

Phase III Randomized Study of Sodium Dichloroacetate in Children With Congenital Lactic Acidosis

NCT00004490 ↗

Phase 3 Completed 45 enrolled University of Florida
RandomizedCrossoverDouble-blindTreatment

Summary

OBJECTIVES: I. Compare the safety of sodium dichloroacetate (DCA) vs placebo in children with congenital lactic acidosis. II. Determine the quality of life of these patients. III. Determine the pharmacokinetics and metabolic fate of DCA over the course of drug administration in these patients.

Timeline

Start
1998-10
Primary completion
—
Completion
2002-09

Drugs

EvaluationDrugModalityDoseRoute
Subject sodium dichloroacetate Small molecule — Oral

Indications