NCT00004490

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 45 (planned)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 3 Months – 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PROTOCOL OUTLINE: This is a randomized, double blind, crossover study. Patients are stratified according to age (3 months to 2 years vs over 2 to 18 years). All patients receive at least 12 months of sodium dichloroacetate (DCA) during a 2 year period of double blind, crossover evaluation of DCA and placebo by mouth. Quality of life is assessed before treatment and periodically during treatment. Completion date provided represents the completion date of the grant per OOPD records

Conditions

• Lactic Acidosis

Interventions

Type	Name	Description
DRUG	sodium dichloroacetate

Timeline

• Start date: 1998-10-01
• Completion: 2002-09-01
• First posted: 1999-10-19
• Last updated: 2015-03-25