Safety, Tolerability and Effects of L-Arginine in Boys With Dystrophinopathy on Corticosteroids
Completed · Phase 1
Conditions studied: Dystrophinopathy, Duchenne Muscular Dystrophy, Becker's Muscular Dystrophy
In brief
The purpose of the study is to assess the safety, tolerability, and effects of L-Arginine on muscles in boys with dystrophinopathy on corticosteroids. Specifically, to see if L-arginine reduces muscle signal abnormalities on MRI done pre and post 30 days of L-arginine administration.
Key facts
- Study ID
- NCT01388764
- Run by
- Massachusetts General Hospital
- People needed
- 7
- Starts
- 2012-01-01
- Expected to finish
- 2012-05-01
- Last updated by the study team
- 2012-07-03
Who can join
Age: 7 and older, up to 11. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- Confirmation of diagnosis of dystrophinopathy, documented by clinical exam and dystrophin DNA mutation analysis
- Ambulatory male subjects between the ages of 7-11 years
- Stable dosage of corticosteroids for 3 months prior to entry (Screening/Baseline Day 0) and during treatment period
- Able to follow instructions and give assent
- Able to complete nonsedated MR
You may not qualify if…
- Presence of metallic orthopedic hardware in the lower extremity that could affect MRI/MRS measurements
- Routine MRI exclusion criteria such as the presence of a pacemaker, cochlear implant, or cerebral aneurysm clip
- Subjects not capable of cooperating during MR examination
- Known hypersensitivity to L-arginine
- Exposure to another investigational agent, investigational supplements, growth hormone within 3 months prior to entry (Screening/Baseline Day 0) or during treatment period
- Subjects must not be taking L-arginine for at least 4 weeks prior to entry (Day 0)
- Subjects who are non-ambulatory or with daytime ventilatory dependence
Where it is running
- Massachusetts General Hospital — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.