NCT04064307

Brief Summary

The Myotubular and Centronuclear Myopathy Patient Registry (also referred to as the 'MTM and CNM Registry') is an international, patient-reported database specific to these conditions. More details and online registration are available at www.mtmcnmregistry.org.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 26, 2013

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

March 6, 2018

Completed
1.5 years until next milestone

First Posted

Study publicly available on registry

August 21, 2019

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

April 9, 2025

Status Verified

April 1, 2025

Enrollment Period

12.1 years

First QC Date

March 6, 2018

Last Update Submit

April 7, 2025

Conditions

Keywords

RegistryPatient RegistryMyotubularCentronuclearMyopathy

Outcome Measures

Primary Outcomes (1)

  • Patient questionnaire

    Patient reported clinical diagnosis, genetic mutation, motor function, wheelchair use, respiratory function, ventilation type, chest infection, feeding and heart function, neuromuscular examinations, scoliosis surgery, family history and other registries joined. No scales are collected. Patient genetic report and muscle biopsy report are also uploaded to the registry if available, with details of clinician and where the tests were conducted.

    12 months

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Eligible participants from any country. Registration is voluntary, and initiated by participants.

You may qualify if:

  • Patients with a myotubular myopathy or centronuclear myopathy diagnosis, which has been confirmed via genetic testing or muscle biopsy.
  • Any carrier females of x-linked myotubular myopathy, especially if they have manifested myotubular myopathy type symptoms.
  • Any patient who is deceased, but who had a confirmed diagnosis.

You may not qualify if:

  • \- None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Newcastle University

Newcastle upon Tyne, Tyne and Wear, NE1 3BZ, United Kingdom

RECRUITING

MeSH Terms

Conditions

Myopathies, Structural, CongenitalMuscular Diseases

Condition Hierarchy (Ancestors)

Musculoskeletal DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • Chiara Marini Bettolo

    Newcastle-upon-Tyne Hospitals NHS Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Neurologist and Clinical Lead, John Walton Muscular Dystrophy Research Centre. Clinical Lead of the Highly Specialised Service for Rare Neuromuscular Diseases, and Honorary Clinical Research Associate at Newcastle University

Study Record Dates

First Submitted

March 6, 2018

First Posted

August 21, 2019

Study Start

March 26, 2013

Primary Completion

May 1, 2025

Study Completion

May 1, 2025

Last Updated

April 9, 2025

Record last verified: 2025-04

Locations