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Completed

NCT Number: NCT02516085

Improved Muscle Function in Duchenne Muscular Dystrophy Through L-Arginine and Metformin

The purpose of the study is to show that the intake of L-arginine and metformin improves muscle function and delays disease progression in patients with Duchenne's muscular dystrophy.

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Key information

Conditions

Duchenne Muscular Dystrophy Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Genetic Diseases, X-Linked Muscular Diseases Muscular Disorders, Atrophic Muscular Dystrophies Muscular Dystrophy, Duchenne Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases

Age range

7 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

This is an investigator-initiated, open-label, single-center, proof-of-concept-study. The study medication consists of L-arginine and metformin. The duration of the study is 16 weeks and comprehends one screening and four study visits.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Molecular diagnosis of DMD
  • Patients 7 - 10 years of age at time of screening
  • Ambulant

Exclusion criteria

  • Previous (3 months or less) or concomitant participation in another therapeutic trial
  • Use of L-arginine, L-citrulline or metformin within the last 3 months
  • Known individual hypersensitivity to L-citrulline or metformin
  • Other chronic disease or clinical relevant limitation of renal, liver, heart function according to discretion of the investigator

Treatment and study plan

metformin

Drug

L-arginine

Drug

Primary outcomes

  1. Mean change of muscle metabolism

    Time frame: baseline to week 16

    mitochondrial protein expression analysis in muscular biopsies

Secondary outcomes

  1. In vivo change of muscle metabolism

    Time frame: baseline to week 16

    indirect calorimetry, Dual-Energy X-Ray Absorptiometry, quantitative thigh muscle MRI, clinical score of muscle performance

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Aug 5, 2015
Registry last updated
Aug 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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