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:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-25 @ 2:07 AM
NCT ID:
NCT05187260
Eligibility Criteria:
Inclusion Criteria:
* Patients genetically confirmed 5q SMA including types I, II and III, who are planning to initiate treatment with SPINRAZA® (nusinersen) as part of their clinical care plan.
* Non-5q SMA patients undergoing clinical standard lumbar puncture
* Non-SMA subjects including Asymptomatic carriers of SMA, relatives of SMA patients and carriers, and patients undergoing clinical standard lumbar puncture
* Participants or Parent(s)/legal guardian(s) willing and able to complete the informed consent process
Exclusion Criteria:
* Contraindication for lumbar puncture
* Inability to access intrathecal space for nusinersen injection
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
1 Week
Maximum Age:
50 Years
Study:
NCT05187260
Study Brief:
Protocol Section:
NCT05187260