Status:

RECRUITING

A Study to Check Liver Health in Boys With XLMTM, a Serious Genetic Muscle Condition

Lead Sponsor:

Astellas Gene Therapies

Conditions:

X-Linked Myotubular Myopathy

Eligibility:

MALE

Up to 17 years

Brief Summary

XLMTM (X-linked myotubular myopathy) is a serious genetic muscle condition. It is caused by changes in the MTM1 gene which stops or slows down normal muscle development, causing severe muscle weakness...

Eligibility Criteria

Inclusion

  • Participant has a diagnosis of XLMTM resulting from a genetically confirmed mutation in the MTM1 gene based on genetic test reports.
  • Participant requires some mechanical ventilatory support (e.g., ranging from 24 hours per day full-time mechanical ventilation, to non-invasive support such as continuous positive airway pressure (CPAP) or bilevel positive airway pressure (BiPAP) during sleeping hours)
  • Participant (as applicable) and/or parent(s)/carer is willing to comply with the recommended schedule of assessments.

Exclusion

  • Participant is currently enrolled in an interventional study designed to treat XLMTM.

Key Trial Info

Start Date :

May 19 2025

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

May 31 2027

Estimated Enrollment :

50 Patients enrolled

Trial Details

Trial ID

NCT06581146

Start Date

May 19 2025

End Date

May 31 2027

Last Update

January 7 2026

Active Locations (5)

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Page 1 of 2 (5 locations)

1

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, United States, 60611

2

Boston Children's Hospital

Boston, Massachusetts, United States, 02115

3

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States, 45229

4

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States, 19104