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 @ 5:26 PM
Ignite Modification Date:
2025-12-24 @ 5:26 PM
NCT ID:
NCT00786968
Eligibility Criteria:
Inclusion Criteria:
* Hurler-Scheie, Scheie form of MPS I, or Hurler 2 years after hematopoietic stem cell transplantation
* Spinal cord compression
* Has received intrathecal laronidase previously with good response and no significant safety concerns
* Age greater than 8 years
* Able to provide legal informed consent
* Aware of clinical treatment option of observation without treatment or surgical decompression
* Negative urine pregnancy test at screening (nonsterile females of child-bearing potential who are sexually active only)
Exclusion Criteria:
* Severe (Hurler) form of MPS I
* Desires surgical or medical treatment of spinal cord compression
* Spinal cord compression that warrants immediate surgical intervention
* Pregnancy or lactation
* Hematopoietic stem cell transplantation within 2 years of study enrollment
* Receipt of an investigational drug within 30 days of enrollment
* Infusion reactions to laronidase that required medical intervention, prophylaxis, or altered enzyme administration
* Significant anti-iduronidase antibody titer
* Recent initiation of intravenous laronidase (within past 6 months)
* Presence of cervical subluxation or similar external pathology as the major cause of cord compression symptoms for which surgical intervention should be immediately undertaken
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Study:
NCT00786968
Study Brief:
Protocol Section:
NCT00786968