Who is sponsoring NCT01596803?

NCT01596803 is sponsored by University Hospital, Montpellier.

What drugs are being tested in NCT01596803?

Interventions in NCT01596803: Taking of blood, needle biopsy of the vastus lateralis muscle, Vit C Vit E Zn Se, Placebo Vit E Placebo Vit C Zn Se.

What condition does NCT01596803 study?

NCT01596803 studies Facioscapulohumeral Muscular Dystrophy.

Is NCT01596803 still recruiting?

NCT01596803 is currently completed. Last updated 12 February 2020.

Last reviewed 2020-02-12 · How we verify

NCT01596803: FSHD

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Effects Antioxidants Supplementation on Muscular Function Patients Facioscapulohumeral Dystrophy (FSHD)

Completed NA Last updated 12 February 2020

What this trial tests

NA trial testing Taking of blood in Facioscapulohumeral Muscular Dystrophy in 54 participants. Completed in 1 June 2012.

Timeline

1 May 2010

Primary endpoint
20 February 2012

1 June 2012

Quick facts

Lead sponsor	University Hospital, Montpellier
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	supportive care
Enrollment	54
Start date	1 May 2010
Primary completion	20 February 2012
Estimated completion	1 June 2012
Sites	1 location across France

Drugs / interventions tested

Taking of blood
needle biopsy of the vastus lateralis muscle
Vit C Vit E Zn Se
Placebo Vit E Placebo Vit C Zn Se

Conditions studied

Facioscapulohumeral Muscular Dystrophy — all drugs for Facioscapulohumeral Muscular Dystrophy →

Sponsor

University Hospital, Montpellier

Who can join

Adults 18 to 60, any sex, with Facioscapulohumeral Muscular Dystrophy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

On the basis of published data and the investigators' results indicating that oxidative stress may contribute to the peripheral skeletal muscle dysfunction in patients with FSHD, the investigators propose a study to test whether or not an antioxidant supplementation has a therapeutic interest for patients with FSHD. Their results have important implications for the successful implementation of rational antioxidant therapy in FSHD in which cell loss could be linked to oxidative stress.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

Effects of vitamin C, vitamin E, zinc gluconate, and selenomethionine supplementation on muscle function and oxidative stress biomarkers in patients with facioscapulohumeral dystrophy: a double-blind randomized controlled clinical trial.
Passerieux E, Hayot M, Jaussent A, Carnac G, et al · · 2015 · cited 84× · PMID 25246239 · DOI 10.1016/j.freeradbiomed.2014.09.014
Early-Onset Infantile Facioscapulohumeral Muscular Dystrophy: A Timely Review.
Chen TH, Wu YZ, Tseng YH. · · 2020 · cited 19× · PMID 33096728 · DOI 10.3390/ijms21207783
Muscle strength, quantity and quality and muscle fat quantity and their association with oxidative stress in patients with facioscapulohumeral muscular dystrophy: Effect of antioxidant supplementation.
Wilson VD, Bommart S, Passerieux E, Thomas C, et al · · 2024 · cited 7× · PMID 38574978 · DOI 10.1016/j.freeradbiomed.2024.04.001
Nutritional Status of Patients with Facioscapulohumeral Muscular Dystrophy.
Amzali S, Wilson VD, Bommart S, Picot MC, et al · · 2023 · cited 4× · PMID 37049513 · DOI 10.3390/nu15071673
Promising Perspective to Facioscapulohumeral Muscular Dystrophy Treatment: Nutraceuticals and Phytochemicals.
Hangül C, Karaüzüm SB, Akkol EK, Demir-Dora D, et al · · 2021 · cited 2× · PMID 34315378 · DOI 10.2174/1570159x19666210726151924

Verify or expand the search:

Other recruiting trials for Facioscapulohumeral Muscular Dystrophy

Currently open trials in the same condition.

NCT06907875 — A First-in-human Study of EPI-321 in Facioscapulohumeral Muscular Dystrophy · Phase 1, PHASE2 · recruiting

Other University Hospital, Montpellier trials

Trials by the same sponsor.

NCT07524127 — Phenotyping of Type 2 Inflammation Profile by Rheology of Nasal Secretions and Tissue Quantification of Eosinophilic Pol · NA · not yet recruiting
NCT07255495 — Effects of Neuromuscular Scoliosis Surgery on Nutritional Metabolism · NA · not yet recruiting
NCT07534189 — Prospective Cohort Study Evaluating a Thermal Spa Programme in Symptomatic Knee Osteoarthritis · NA · not yet recruiting
NCT07515638 — Immun4Cure Cohort of Autoimmune Diseases · not yet recruiting
NCT07406516 — Identification of Kinematic Variables Specific of Patellar Tendinopathy in Athletes at Risk · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01596803 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University Hospital, Montpellier
Last refreshed: 12 February 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01596803.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing