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:
2025-12-24 @ 9:48 PM
Ignite Modification Date:
2025-12-24 @ 9:48 PM
NCT ID:
NCT00639132
Eligibility Criteria:
Inclusion Criteria:
1. The patient must have a confirmed diagnosis of MLD as defined by:
ASA activity \< 10 nmol/h/mg in leukocytes
Presence of elevated sulfatide in urine
2. The patient must have voluntary function (as judged by the investigator), including cognitive and motor function that is no more than 3 standard deviations below normal at the time of enrollment.
3. The patient must have an age at the time of screening birth to \< 6 years
4. The patient must have had onset of symptoms before the age of 4 years
5. The subject and his/her guardian(s) must have the ability to comply with the clinical protocol
Exclusion Criteria:
1. Known multiple sulfatase deficiency
2. Presence of major congenital abnormality
3. Presence of known chromosomal abnormality and other neurological conditions unrelated to MLD that can affect psychomotor development
4. History of hematopoietic stem cell transplantation
5. Presence of known clinically significant cardiovascular, hepatic, pulmonary or renal disease or other medical condition
6. Any other medical condition or serious intercurrent illness, or extenuating circumstance that, in the opinion of the principal investigator, would preclude participation in the trial
7. Use of any investigational product within 30 days prior to study enrollment or currently enrolled in another study which involves clinical investigations.
8. The patient's parent(s) and/or legal guardian is unable to understand the nature, scope, and possible consequences of the study.
9. Patient is unable to comply with the protocol, i.e. inability to return for follow-up evaluations or otherwise unlikely to complete the study as determined by the principal investigator.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
6 Years
Study:
NCT00639132
Study Brief:
Protocol Section:
NCT00639132