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 @ 4:39 PM
Ignite Modification Date:
2025-12-24 @ 4:39 PM
NCT ID:
NCT05632666
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 8 years;
* Respiratory muscle weakness (PImax ≤80 cmH2O (31));
* Maintenance dose (≥2 months) Spinraza® or (≥2 months) Risdiplam or no treatment;
* Given oral and written informed consent when ≥18 years old and additional informed consent by the parents or legal representative if the participant is \<16 years old.
Exclusion Criteria:
* Inability to perform respiratory and/or lung-function testing;
* Inability to understand Dutch or English;
* A history of pneumothorax or symptomatic low cardiac output syndrome;
* Treatment period \< 2 months of Spinraza® or Risdiplam
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Study:
NCT05632666
Study Brief:
Protocol Section:
NCT05632666