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 @ 3:21 AM
Ignite Modification Date:
2025-12-25 @ 3:21 AM
NCT ID:
NCT02057705
Eligibility Criteria:
Inclusion criteria:
* Patients of any age (newborns included) may participate.
* Patients over 18 years of age and parent(s)/legal guardian(s) of patients \<18 years of age must provide written informed consent prior to participating in the study and informed assent will be obtained from minors at least 7 years of age when required by regulation.
* MTM resulting from a mutation in the MTM1 gene.
* Male or symptomatic female. A symptomatic female will be defined by the motor function assessment by Motor Function Measure (MFM) or North Star Ambulatory Assessment (NSAA) below 80% of the total score.
* Willing and able to comply with all protocol requirements and procedures.
Exclusion criteria:
* Other disease which may significantly interfere with the assessment of MTM and is clearly not related to the disease.
* Currently enrolled in a treatment study; or treatment with an experimental therapy other than pyridostigmine.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT02057705
Study Brief:
Protocol Section:
NCT02057705