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 @ 7:58 PM
Ignite Modification Date:
2025-12-24 @ 7:58 PM
NCT ID:
NCT01306604
Eligibility Criteria:
INCLUSION CRITERIA:
* Informed consent will be obtained from the patient or the parents before any study related procedures.
* Patients of both gender from one day old
* The patient has a diagnosis of Niemann Pick Type C disease or profound suspicion for Niemann Pick Type C disease
* High-grade suspicion present, if one or more criteria are valid:
Positive family anamnesis for NPC1/NPC2
Splenomegaly without identifiable cause
Hepatomegaly without identifiable cause
Neurological symptoms without identifiable cause
Psychiatric symptoms without identifiable cause
EXCLUSION CRITERIA:
* No Informed consent from the patient or the parents before any study related procedures.
* No diagnosis of NPC1/NPC2 or no valid criteria for high-grade suspicion of NPC1/ NPC2
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Day
Study:
NCT01306604
Study Brief:
Protocol Section:
NCT01306604