Clinical Trial: L-citrulline and Metformin in Becker's Muscular Dystrophy
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Pilot Study to Assess the Efficacy of L-Citrulline and Metformin in Adults With Becker's Muscular Dystrophy
Brief Summary: 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).
Detailed Summary:
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.
Sponsor: University Hospital, Basel, Switzerland
Current Primary Outcome: Mean change of motor function measure (MFM) D1 subscore after 6 and 12 weeks [ Time Frame: week 6 and week 12 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- MFM total score and six minute walking distance (6MWD) [ Time Frame: week 6 and week 12 ]
- Change of muscle fat content (MFC) (assessed by MRI) [ Time Frame: week 6 and week 12 ]
- Change of muscle metabolism (assessed by dual energy x-ray absorptiometry (DEXA) and indirect calorimetry) [ Time Frame: week 6 and week 12 ]
- Change of laboratory parameters (oxidative and nitrosative stress) [ Time Frame: week 6 and week 12 ]
Original Secondary Outcome: Same as current
Information By: University Hospital, Basel, Switzerland
Dates:
Date Received: December 17, 2013
Date Started: June 2013
Date Completion:
Last Updated: May 13, 2016
Last Verified: May 2016
