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:
2025-12-26 @ 10:18 PM
Ignite Modification Date:
2025-12-26 @ 10:18 PM
NCT ID:
NCT02298712
Eligibility Criteria:
INCLUSION CRITERIA
* Informed consent will be obtained from the parents before any study related procedures.
* Patients of both gender older than 2 month
* The patient has a diagnosis of Hurler disease or a high-grade suspicion for Hurler disease
* High-grade suspicion present, if one or more inclusion criteria are valid:
1. \- Positive family anamnesis for Hurler disease
2. \- Macrocephaly
3. \- Deformed bones and stiff joints, especially the spine, hips, knees, wrists and fingers
4. \- Musculoskeletal alterations including short stature
5. \- Developmental delay and/or progressive mental deterioration
EXCLUSION CRITERIA
* No Informed consent from the parents before any study related procedures.
* Patients of both gender younger than 2 month
* No diagnosis of Hurler disease or no valid criteria for profound suspicion of Hurler disease
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Months
Study:
NCT02298712
Study Brief:
Protocol Section:
NCT02298712