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 @ 1:32 AM
Ignite Modification Date:
2025-12-25 @ 1:32 AM
NCT ID:
NCT04317794
Eligibility Criteria:
Key Inclusion Criteria:
* Currently receiving or about to initiate treatment with commercial Spinraza in the postmarketing setting
* Genetic documentation of 5q-linked SMA
Key Exclusion Criteria:
* Hypersensitivity to the active substance or any of the excipients of Spinraza
* Ongoing participation or participation within 6 months or 5 half-lives of the agent (whichever is longer) of enrollment in other interventional clinical trials for the treatment of SMA
* Inability to comply with study requirements
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT04317794
Study Brief:
Protocol Section:
NCT04317794