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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 August 2015
• Main ID: NCT02516085
• Date of registration: 03/08/2015
• Prospective Registration: No
• Primary sponsor: University Hospital, Basel, Switzerland
• Public title: Improved Muscle Function in Duchenne Muscular Dystrophy Through L-Arginine and Metformin
• Date of first enrolment: January 2012
• Target sample size: 5
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02516085
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Contacts

• Name: Dirk Fischer, MD
• Affiliation: University of Basel, Children's Hospital

Key inclusion & exclusion criteria

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



Age minimum: 7 Years
Age maximum: 10 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Duchenne Muscular Dystrophy

Intervention(s)

Drug: L-Arginine

Drug: Metformin

Primary Outcome(s)

Mean change of muscle metabolism [Time Frame: baseline to week 16]

Secondary Outcome(s)

In vivo change of muscle metabolism [Time Frame: baseline to week 16]

Secondary ID(s)

DMD01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors