A Study of the Natural History of Participants With LGMD2E/R4, LGMD2D/R3, LGMD2C/R5, and LGMD2A/R1 ≥ 4 Years of Age, Who Are Managed in Routine Clinical Practice

Description

This study will follow participants who are screened and confirmed with a genetic diagnosis of Limb-girdle muscular dystrophy type 2E (LGMD2E/R4), Limb-girdle muscular dystrophy type 2D (LGMD2D/R3), Limb-girdle muscular dystrophy type 2C (LGMD2C/R5), or Limb-girdle muscular dystrophy type 2A (LGMD2A/R1). These enrolled participants will be followed to evaluate mobility and pulmonary function for up to 5 years after enrollment for participants with LGMD2C/R5, LGMD2D/R3, and LGMD2E/R4 with a North Star Assessment for Dysferlinopathy (NSAD) ≥ 25 at Baseline, up to 3 years for participants with LGMD2C/R5, LGMD2D/R3, and LGMD2E/R4 with a NSAD \< 25 at Baseline, and up to 3 years for participants with LGMD2A/R1. Additional participant data will be collected from the time the individual began experiencing LGMD symptoms to the present.

Conditions

Limb-girdle Muscular Dystrophy

Study Overview

Study Details

Study overview

This study will follow participants who are screened and confirmed with a genetic diagnosis of Limb-girdle muscular dystrophy type 2E (LGMD2E/R4), Limb-girdle muscular dystrophy type 2D (LGMD2D/R3), Limb-girdle muscular dystrophy type 2C (LGMD2C/R5), or Limb-girdle muscular dystrophy type 2A (LGMD2A/R1). These enrolled participants will be followed to evaluate mobility and pulmonary function for up to 5 years after enrollment for participants with LGMD2C/R5, LGMD2D/R3, and LGMD2E/R4 with a North Star Assessment for Dysferlinopathy (NSAD) ≥ 25 at Baseline, up to 3 years for participants with LGMD2C/R5, LGMD2D/R3, and LGMD2E/R4 with a NSAD \< 25 at Baseline, and up to 3 years for participants with LGMD2A/R1. Additional participant data will be collected from the time the individual began experiencing LGMD symptoms to the present.

Journey: A Global, Multicenter, Longitudinal Study of the Natural History of Subjects With Limb Girdle Muscular Dystrophy (LGMD) Type 2E (LGMD2E/R4), Type 2D (LGMD2D/R3), Type 2C (LGMD2C/R5), and Type 2A (LGMD2A/R1)

A Study of the Natural History of Participants With LGMD2E/R4, LGMD2D/R3, LGMD2C/R5, and LGMD2A/R1 ≥ 4 Years of Age, Who Are Managed in Routine Clinical Practice

Condition
Limb-girdle Muscular Dystrophy
Intervention / Treatment

-

Contacts and Locations

Phoenix

Barrow Neurological Institute, Phoenix, Arizona, United States, 85013

Little Rock

Arkansas Children's, Little Rock, Arkansas, United States, 72202

La Jolla

University of California San Diego, La Jolla, California, United States, 92037

Sacramento

University of California, Davis Health Dept of PM&R, Sacramento, California, United States, 95817

Chicago

Anne & Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois, United States, 60611

Columbus

Nationwide Children's Hospital, Columbus, Ohio, United States, 43205

Portland

Oregon Health and Science University, Portland, Oregon, United States, 97068

Philadelphia

The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States, 19104

Dallas

University of Texas Southwestern Medical Center, Dallas, Texas, United States, 75201

Salt Lake City

University of Utah Hospital, Salt Lake City, Utah, United States, 84112

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Male or female participant ≥ 4 years of age who demonstrate symptoms of LGMD2E/R4, LGMD2D/R3, LGMD2C/R5, or LGMD2A/R1 in the opinion of the investigator (eg, muscle weakness, loss of function, delayed milestones).
  • * Confirmed clinical and genetic diagnosis of LGMD2E/R4, LGMD2D/R3, LGMD2C/R5, or LGMD2A/R1.
  • * Demonstrates cognitive delay or impairment that could confound motor development, in the opinion of the Investigator.
  • * Has a medical condition, in the opinion of the Investigator, that might compromise participants ability to comply with study requirements.
  • * Is participating in other interventional study(ies) at the time of enrollment in this study.

Ages Eligible for Study

4 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Sarepta Therapeutics, Inc.,

Medical Director, STUDY_DIRECTOR, Sarepta Therapeutics, Inc.

Study Record Dates

2030-04-30