NCT03445832

Brief Summary

This study aims to describe the evolution of pulmonary function in 3 neuromuscular diseases : Duchenne muscular dystrophy, Werdnig-Hoffinann disease, congenital myopathy, monitored in Besançon university hospital.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

January 8, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2018

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

February 20, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 26, 2018

Completed
Last Updated

August 17, 2018

Status Verified

August 1, 2018

Enrollment Period

1 month

First QC Date

February 20, 2018

Last Update Submit

August 16, 2018

Conditions

Neuromuscular Diseases

Outcome Measures

Primary Outcomes (1)

  • FVC (Forced Vital Capacity)

    Percentage of decrease of FVC sitting or lying down

    Year 12

Eligibility Criteria

Age6 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children suffering from neuromuscular diseases and followed-up in Besançon University Hospital between 2006/01/01 and the beginning of this study

You may qualify if:

  • Neuromuscular disease
  • Followed-up in Besançon University Hospital
  • With at least 2 Pulmonary Function Tests previously performed

You may not qualify if:

  • Mental deficiency
  • Facial expressions disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Besançon

Besançon, France

Location

MeSH Terms

Conditions

Neuromuscular Diseases

Condition Hierarchy (Ancestors)

Nervous System Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2018

First Posted

February 26, 2018

Study Start

January 8, 2018

Primary Completion

February 10, 2018

Study Completion

February 10, 2018

Last Updated

August 17, 2018

Record last verified: 2018-08

Locations

FR(1)