Trial Readiness and Trial Fitness for Congenital Myopathies: a 2-year Prospective Natural History Study Including a Cross-sectional Study on Muscle Fatigability

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Observational
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 treatment is available for these groups. Also patients report fatigability as one of their symptoms. The goal of this observational study is to study the natural history during 24 months to achieve trial readiness and to study the muscle fatigability in CCD/MmD, NEM and CNM.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Healthy Volunteers: f
View:

• 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)

• 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.

Locations
Other Locations
Netherlands
Radboudumc
RECRUITING
Nijmegen
UMC Utrecht
NOT_YET_RECRUITING
Utrecht
Contact Information
Primary
Nicol Voermans, MD PhD
Nicol.Voermans@radboudumc.nl
+31650155770
Time Frame
Start Date: 2024-03-28
Estimated Completion Date: 2026-11
Participants
Target number of participants: 100
Treatments
Core myopathies
Patients with a genetically confirmed core myopathy
Nemaline myopathy
Patients with a genetically confirmed nemaline myopathy
Centronuclear myopathy
Patients with a genetically confirmed centronuclear myopathy
Sponsors
Collaborators: UMC Utrecht
Leads: Radboud University Medical Center

This content was sourced from clinicaltrials.gov