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Phase II Pilot Randomized Study of Sodium Dichloroacetate in Patients With Congenital Lactic Acidemia Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about Phase II Pilot Randomized Study of Sodium Dichloroacetate in Patients With Congenital Lactic Acidemia conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Phase II Pilot Randomized Study of Sodium Dichloroacetate in Patients With Congenital Lactic Acidemia Clinical research trials and Phase II Pilot Randomized Study of Sodium Dichloroacetate in Patients With Congenital Lactic Acidemia healthcare trials happen in hundreds of localities throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as Phase II Pilot Randomized Study of Sodium Dichloroacetate in Patients With Congenital Lactic Acidemia. Phase II Pilot Randomized Study of Sodium Dichloroacetate in Patients With Congenital Lactic Acidemia Clinical Trials and other clinical trials allow volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Phase II Pilot Randomized Study of Sodium Dichloroacetate in Patients With Congenital Lactic Acidemia clinical trial. Subjects frequently obtain the most expert healthcare possible for their Phase II Pilot Randomized Study of Sodium Dichloroacetate in Patients With Congenital Lactic Acidemia condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
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Home > "P" Clinical Trials Conditions > Phase II Pilot Randomized Study of Sodium Dichloroacetate in Patients With Congenital Lactic Acidemia  Phase II Pilot Randomized Study of Sodium Dichloroacetate in Patients With Congenital Lactic Acidemia
Phase II Pilot Randomized Study of Sodium Dichloroacetate in Patients With Congenital Lactic Acidemia
For Condition: Lactic Acidosis
Status: Recruiting
Sponsor(s): FDA Office of Orphan Products Development , University of California, San Diego
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 3 Months/
Genders: Both
Protocol Entry 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
Total Enrollment: 75
Location and Contact Information:
Overall Study Official:
BruceBarshop, Study Chair, University of California, San Diego
University of California San Diego School of Medicine *Recruiting*
La Jolla, California, 92093-0652
United States
Recruiting Bruce Barshop 619-543-5237
Additional Information:
Study ID Numbers: 199/14274; UCSD-FDR001481
Study Start Date: September 1998
Record last reviewed: May 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004493
Other Lactic Acidosis Studies:
1. Phase III Randomized Study of Sodium Dichloroacetate in Children with Congenital Lactic Acidosis
2. Phase II Pilot Randomized Study of Sodium Dichloroacetate in Patients With Congenital Lactic Acidemia
3. Dichloroacetate Kinetics, Metabolism and Toxicology
4. Study of the Metabolism of Pyruvate and Related Problems in Patients with Lactic Acidemia
Related Studies:
Other Lactic Acidosis Clinical Trials
Other California Clinical Trials
Other La Jolla Clinical Trials
Phase II Pilot Randomized Study of Sodium Dichloroacetate in Patients With Congenital Lactic Acidemia
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