Actively Recruiting

Age: 0 - 59Months
All Genders
NCT05224778

DMCRN-02-001: Assessing Pediatric Endpoints in DM1

Led by Virginia Commonwealth University · Updated on 2025-06-11

50

Participants Needed

5

Research Sites

222 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The overall goal of the study is to establish valid clinical endpoint assessments for children with congenital myotonic dystrophy type 1 and develop biomarkers for the condition.

CONDITIONS

Official Title

DMCRN-02-001: Assessing Pediatric Endpoints in DM1

Who Can Participate

Age: 0 - 59Months
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age from newborn to 3 years 11 months at enrollment
  • Diagnosis of congenital myotonic dystrophy with symptoms starting within 30 days of birth such as low muscle tone, feeding or breathing difficulties requiring hospitalization over 72 hours
  • Genetic confirmation of an expanded CTG repeat in the DMPK gene in the child or mother (greater than 200 repeats)
  • Guardian willing and able to provide consent and comply with study procedures
Not Eligible

You will not qualify if you...

  • Presence of other non-DM1 illnesses that could interfere with study participation or outcomes
  • Significant trauma within the past month
  • Internal metal or devices preventing certain study components
  • History of bleeding disorder or platelet count below 50,000
  • History of reaction to local anesthetic

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 5 locations

1

University of California, Los Angeles

Los Angeles, California, United States, 90095

Actively Recruiting

2

University of Kansas Medical Center

Fairway, Kansas, United States, 66205

Actively Recruiting

3

University of Rochester Medical Center

Rochester, New York, United States, 14642

Actively Recruiting

4

Virginia Commonwealth University

Richmond, Virginia, United States, 23298

Actively Recruiting

5

Centro Clinico NeMO

Milan, Italy, 20162

Actively Recruiting

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Research Team

R

Ruby Langeslay

CONTACT

J

Jennifer Raymond

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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