Phase III Randomized Study of Sodium Dichloroacetate in Children With Congenital Lactic Acidosis
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.
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
|Study Start Date:||October 1998|
|Estimated Study Completion Date:||September 2002|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004490
|Study Chair:||Peter W. Stacpoole||University of Florida|