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 @ 7:02 PM
Ignite Modification Date:
2025-12-24 @ 7:02 PM
NCT ID:
NCT01840657
Eligibility Criteria:
Inclusion Criteria:
* males with a confirmed MTM1 mutation OR
* males with a muscle biopsy consistent with myotubular myopathy AND family history consistent with X-linked inheritance AND
* English-speaking parent/guardian of a living male child or a decisionally impaired adult OR English-speaking affected male over 18 years of age who can access telephone
* signed study consent
* enrolled in the Congenital Muscle Disease International Registry (CMDIR)
Exclusion Criteria:
* males with only a clinical diagnosis of XLMTM but without family history of XLMTM
* an affected male who has a genetically confirmed form of centronuclear myopathy (CNM) that is not caused by a mutation in the MTM1 gene
* females with MTM1 due to the limited number of females affected and the variability of clinical presentation
Healthy Volunteers:
False
Sex:
MALE
Study:
NCT01840657
Study Brief:
Protocol Section:
NCT01840657