Expired Study
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La Jolla, California 92093


Purpose:

OBJECTIVES: I. Determine the pharmacokinetics of sodium dichloroacetate (DCA) in patients with congenital lactic acidemia. II. Determine the efficacy of DCA in decreasing the frequency and/or severity of acute episodes of acidotic illness, improving linear growth, improving neurological or developmental function, or slowing neurological or developmental deterioration in these patients.


Study summary:

PROTOCOL OUTLINE: This is a randomized, double blind, cross over study. Patients are randomized to start with one of two different doses of sodium dichloroacetate (DCA). Patients receive one of two doses of oral DCA for 6 months, then switch to the alternate dose for 6 months. This course is repeated once. Patients are followed for up to 2 years. Completion date provided represents the completion date of the grant per OOPD records


Criteria:

PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Diagnosis of stable, persistent lactic acidemia Venous lactate at least 3 mM under basal conditions defined as: At least 4 hours postprandial No concurrent illness OR - Diagnosis of cerebral lactic acidemia with elevated lactic acid in CSF but not in the blood - No organic acidemias or defective gluconeogenesis --Patient Characteristics-- - Hematopoietic: Hemoglobin at least 7 mg/dL - Hepatic: Bilirubin no greater than 3 times upper limit of normal (ULN) AST, ALT, or GGT no greater than 10 times ULN - Renal: Creatinine no greater than 2 mg/dL - Cardiovascular: Ejection fraction at least 25% - Other: No hypoglycemia (blood sugar less than 50 mg/dL at no greater than 12 hours fasting) No severe peripheral neuropathy interfering with normal activities of living


NCT ID:

NCT00004493


Primary Contact:

Study Chair
Bruce Barshop
University of California, San Diego


Backup Contact:

N/A


Location Contact:

La Jolla, California 92093
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 20, 2017

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