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 @ 11:10 PM
Ignite Modification Date:
2025-12-24 @ 11:10 PM
NCT ID:
NCT05272969
Eligibility Criteria:
Inclusion Criteria: A patient must meet the following criteria to be eligible for this study:
1. The patient is willing and able to provide signed informed consent.
2. The patient is able and willing to perform study-related assessments.
3. A) The patient is ≥18 years of age with acid α-glucosidase \[GAA\] enzyme deficiency, confirmed by GAA gene mutation analysis, or B) The patient has a histologically confirmed diagnosis of inclusion body myositis (IBM), or a genetically confirmed spinal muscular atrophy type 3 (SMA3) or a genetically confirmed facio-scapulo-humeral muscle dystrophy (FSHD).
Exclusion Criteria: A patient who meets any of the following criteria will be excluded from this study.
1. The patient is participating in another clinical study or using an investigational treatment.
2. The patient, in the opinion of the Investigator, is unable to adhere to the requirements of the study.
3. The patient has currently a severe depression, assessed by the Beck depression inventory fast screen (BDI-FS) with a score ≥ 4
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05272969
Study Brief:
Protocol Section:
NCT05272969