Routine Health Care of Patients With FSHD (FSHD)
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ClinicalTrials.gov Identifier: NCT02622438 |
Recruitment Status :
Recruiting
First Posted : December 4, 2015
Last Update Posted : April 13, 2020
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Sponsor:
University Hospital, Montpellier
Information provided by (Responsible Party):
University Hospital, Montpellier
Tracking Information | |||||
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First Submitted Date ICMJE | November 30, 2015 | ||||
First Posted Date ICMJE | December 4, 2015 | ||||
Last Update Posted Date | April 13, 2020 | ||||
Actual Study Start Date ICMJE | April 19, 2015 | ||||
Estimated Primary Completion Date | March 2025 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
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Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Routine Health Care of Patients With FSHD | ||||
Official Title ICMJE | Course and Follow up of Patients Affected by Facioscapulohumeral Dystrophy | ||||
Brief 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. | ||||
Detailed 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. | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Not Applicable | ||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Supportive Care |
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Condition ICMJE | Primary Disease Fascioscapulohumeral Dystrophy (FSHD) | ||||
Intervention ICMJE | Other: Followed with an initial assessment, six months and followed annually for 3 years corresponding to the usual follow-up of the patient. | ||||
Study Arms ICMJE | Course and follow up of patients affected by 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.
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Recruiting | ||||
Estimated Enrollment ICMJE |
200 | ||||
Original Estimated Enrollment ICMJE |
40 | ||||
Estimated Study Completion Date ICMJE | March 2025 | ||||
Estimated Primary Completion Date | March 2025 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 7 Years and older (Child, Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE |
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Listed Location Countries ICMJE | France | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT02622438 | ||||
Other Study ID Numbers ICMJE | 9371 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product | Not Provided | ||||
IPD Sharing Statement ICMJE | Not Provided | ||||
Responsible Party | University Hospital, Montpellier | ||||
Study Sponsor ICMJE | University Hospital, Montpellier | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | University Hospital, Montpellier | ||||
Verification Date | April 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |