Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-25 @ 1:27 AM
NCT ID:
NCT00004493
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Months
Study:
NCT00004493
Study Brief:
Protocol Section:
NCT00004493