Routine Health Care of Patients With FSHD

Primary Disease Fascioscapulohumeral Dystrophy (FSHD) Clinical Trial

— FSHD  

Official title:

Course and Follow up of Patients Affected by Facioscapulohumeral Dystrophy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02622438
• Other study ID #: 9371
• Status: Recruiting
• Phase: N/A
• Start date: April 19, 2015
• Est. completion date: March 2025

Study information

• Verified date: February 2022
• Source: University Hospital, Montpellier
• Contact: Jacques MERCIER, MD PhD
• Email: jacques.mercier[@]umontpellier.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

On the basis of published data and our results indicating that oxidative stress may contribute to the peripheral skeletal muscle dysfunction in patients with FSHD, investigators conducted a pilot randomized double-blind placebo controlled trial to test whether oral administration of vitamins and mineral could improve the physical performance of patients with FSHD.The result of this clinical trial showed that antioxidants supplementation may improve skeletal muscle function of patients with FSHD and suggest that an antioxidant strategy adapted may be a relevant therapeutic approach for these patients. Since then, patients with FSHD who attend consultation at Montpellier hospital are systematically supplemented with antioxidants according their own blood tests.

Description:

This study will assess course of patients with FSHD in accordance with usual care performed within the Department of clinical physiology at the University hospital of Montpellier. This prospective longitudinal study include an initial assessment. Then the follow up of patients will be monitored at 6 months and annually for a period of six years. The eventual objective will be to develop a FSHD disease cohort in care at the Montpellier hospital.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years and older

Eligibility

Inclusion Criteria:

• Molecular and clinical diagnosis for FSHD

• patients, men and women aged < 7 years,

Exclusion Criteria:

• pregnant women

• Inability to understand the nature and goals of the study and / or communication difficulties with the investigator

• Major protected by law (guardianship, curatorship or under judicial protection)

Related Conditions & MeSH terms

• Primary Disease Fascioscapulohumeral Dystrophy (FSHD)

Intervention

Other:
• Followed with an initial assessment, six months and followed annually for 3 years corresponding to the usual follow-up of the patient.

Locations

Country	Name	City	State
France	Montpellier University Hospital- Saint Eloi Hospital	Montpellier	Languedoc-Roussillon

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of usual care performed at Montpellier hospital on the measurement of the maximal voluntary contraction (MVC) of quadriceps expressed in kg		12 months after inclusion
Primary	Effect of usual care performed at Montpellier hospital on the measurement of the maximal voluntary contraction (MVC) of quadriceps expressed in kg		24 months after inclusion
Primary	Effect of usual care performed at Montpellier hospital on the measurement of the maximal voluntary contraction (MVC) of quadriceps expressed in kg		36 months after inclusion
Primary	Effect of usual care performed at Montpellier hospital on the measurement of the maximal voluntary contraction (MVC) of quadriceps expressed in kg		72 months after inclusion
Secondary	Effect of usual care performed at Montpellier hospital on quality of life (SF36 questionnaire)		the day of inclusion
Secondary	Effect of usual care performed at Montpellier hospital on quality of life (SF36 questionnaire)		12 months after inclusion
Secondary	Effect of usual care performed at Montpellier hospital on quality of life (SF36 questionnaire)		24 months after inclusion
Secondary	Effect of usual care performed at Montpellier hospital on quality of life (SF36 questionnaire)		36 months after inclusion
Secondary	Effect of usual care performed at Montpellier hospital on quality of life (SF36 questionnaire)		72 months after inclusion
Secondary	Effect of usual care performed at Montpelier hospital on physical activities (Vorrips questionnaire)		the day of inclusion
Secondary	Effect of usual care performed at Montpellier hospital on physical activities (Vorrips questionnaire)		12 months after inclusion
Secondary	Effect of usual care performed at Montpelier hospital on physical activities (Vorrips questionnaire)		24 months after inclusion
Secondary	Effect of usual care performed at Montpelier hospital on physical activities (Vorrips questionnaire)		36 months after inclusion
Secondary	Effect of usual care performed at Montpelier hospital on physical activities (Vorrips questionnaire)		72 months after inclusion
Secondary	Effect of usual care performed at Montpellier hospital on oxidative stress markers measured by laboratory tests		the day of inclusion
Secondary	Effect of usual care performed at Montpellier hospital on oxidative stress markers measured by laboratory tests		12 months after inclusion
Secondary	Effect of usual care performed at Montpellier hospital on oxidative stress markers measured by laboratory tests		24 months after inclusion
Secondary	Effect of usual care performed at Montpellier hospital on oxidative stress markers measured by laboratory tests		36 months after inclusion
Secondary	Effect of usual care performed at Montpellier hospital on oxidative stress markers measured by laboratory tests		72 months after inclusion