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 @ 5:53 PM
Ignite Modification Date:
2025-12-24 @ 5:53 PM
NCT ID:
NCT00330668
Eligibility Criteria:
Inclusion Criteria:
* Parents or legally authorized representatives must give signed informed consent before any trial related activities are conducted
* Where required, assent of the subject will be appropriately documented prior to any study related activities
* Completion of assessments at Visit 9 (Month 120 of Study MS301 \[NCT00125164\])
Exclusion Criteria:
* Incomplete participation in MS301 (NCT00125164)
* Known or suspected allergy to the trial product (mecasermin, recombinant human IGF-1 injection) or its formulation
* Development or presence of a chronic condition except as approved by the Medical Monitor
* Pregnancy
* Any social or medical condition that, in the opinion of the investigator, would be detrimental to either the subject or the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
15 Years
Study:
NCT00330668
Study Brief:
Protocol Section:
NCT00330668