L-citrulline and Metformin in Becker's Muscular Dystrophy
Status and phase
Conditions
Treatments
Details and patient eligibility
About
The purpose of the study is to compare the effects of L-citrulline and metformin and their combination therapy on muscle function and force in patients with Becker muscular dystrophy (BMD).
Full description
This is a single center, not-randomized open study. The study medication consists of L-citrulline and metformin administered orally; 5g citrulline and 500mg metformin tablets will be given 3 times daily.
Half of the patients will be treated with metformin during the first 6 weeks of the study. The other patients will receive initially L-citrulline for 6 weeks, before all patients will be treated with the combination therapy (metformin and L-citrulline) for another 6 week period.
The study lasts 12 weeks and includes the screening visit and 3 further visits at baseline, week 6 and week 12.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- 18 years or older
- Molecular or immunohistochemical diagnosis of BMD
- ambulant at the time point of screening
Exclusion criteria
- Participation in another therapeutic BMD study within the last 3 months
- Use of L-Arginine, L-Citrulline or Metformin within the last 3 months
- Other chronic disease or relevant limitation of renal, liver, heart function according to discretion of investigator
- known hypersensitivity to L-citrulline or metformin
Trial design
Primary purpose
Allocation
Interventional model
Masking
20 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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