Safety, Tolerability and Effects of L-Arginine in Boys With Dystrophinopathy on Corticosteroids

NCT01388764 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2012-07-03

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

L-arginine

Subjects will receive oral L-Arginine (0.3 grams/kg/day, divided 2 times per day, not to exceed 14 grams/day)

Sponsors & Collaborators

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Namita Goyal, MD · Massachusetts General Hospital

Study Design

Allocation
NON_RANDOMIZED
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
7 Years
Max Age
11 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2012-05-31
Completion
2012-05-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01388764 on ClinicalTrials.gov