L-citrulline and Metformin in Duchenne's Muscular Dystrophy

• Status: Completed
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Basel, Switzerland
• Treatments: Metformin

Criteria

Inclusion Criteria:

• Molecular diagnosis of DMD

• Patients 6.5 - 10 years of age at time of screening

• Ambulant

• Ability to walk 150 m in the 6 min walking distance (6MWT)

• D1 subdomain of the MFM scale >40%

• stable treatment with steroids for >6 months or steroid naïve patients

Exclusion Criteria:

• Previous (3 months or less) or concomitant participation in another therapeutic trial

• Use of L-citrulline, L-arginine or metformin within the last 3 months

• Known individual hypersensitivity to L-citrulline or metformin

• known or suspected malignancy

• Other chronic disease or clinical relevant limitation of renal, liver, heart function according to discretion of investigator

• start of cortisone treatment or change in dosage <6 months prior to screening