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 @ 10:47 PM
Ignite Modification Date:
2025-12-24 @ 10:47 PM
NCT ID:
NCT06977269
Eligibility Criteria:
Inclusion Criteria:
* Subject has a diagnosis of 5q-autosomal recessive SMA confirmed by DNA test.
* Informed consent.
* A minimum score of 1 for Entry Item "A" of the Revised Upper Limb Module (RULM) scale for SMA: "Can use hands to hold pencil or pick up a coin/token or drive a powered chair, use phone key pad"
Exclusion Criteria:
* Subject has severe joint contractures that would affect ability to perform study measures, determined by the study physician.
* Subject has a deconditioned respiratory system, per the discretion of the physician investigator.
* Subject has behavioral or cognitive problems that preclude participation in the study, in the opinion of the investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT06977269
Study Brief:
Protocol Section:
NCT06977269