Status:

RECRUITING

The Natural History and Muscle Fatigability of Patients With Congenital Myopathies.

Lead Sponsor:

Radboud University Medical Center

Collaborating Sponsors:

UMC Utrecht

Conditions:

Central Core Disease

Multi-Minicore Disease

Eligibility:

All Genders

2+ years

Brief Summary

Core myopathies (CCD/MmD), nemaline myopathies (NEM) and centronuclear myopathies (CNM) are three types of rare congenital myopathies. Not much is known about the natural history and no curative treat...

Detailed Description

Rationale: Patients with CCD/MmD, NEM and CNM report symptoms of weakness in the arms and legs. Other symptoms include weakness of the respiratory, facial and swallowing muscles. No treatments are ava...

Eligibility Criteria

Inclusion Criteria for the natural history:

  • 2 years or older
  • Willing and able to complete the measurement protocol
  • Willing and able to travel to Nijmegen and Utrecht
  • Dutch-speaking
  • Genetically-confirmed congenital myopathy (CCD/MmD, NEM, and CNM)

Inclusion Criteria for the fatigability study:

  • 8-60 years old
  • Willing and able to complete the measurement protocol
  • Willing and able to travel to Nijmegen and Utrecht
  • Dutch-speaking
  • Genetically-confirmed congenital myopathy (CCD/MmD, NEM, and CNM)
  • Willing to stop taking pyridostigmine and/or salbutamol 24 hours before the visit.

Exclusion Criteria for both parts:

Other neuromuscular, psychiatric or neurological disorders.

Key Trial Info

Start Date :

March 28 2024

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

November 1 2026

Estimated Enrollment :

100 Patients enrolled

Trial Details

Trial ID

NCT06157268

Start Date

March 28 2024

End Date

November 1 2026

Last Update

August 19 2024

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Radboudumc

Nijmegen, Gelderland, Netherlands, 6500HB

2

UMC Utrecht

Utrecht, Netherlands, 3584 CX