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NCT01388764 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability and Effects of L-Arginine in Boys With Dystrophinopathy on Corticosteroids
A Phase 1 study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 1
- Development phase
- 7
- Enrollment target
NCT01388764: Completed Phase 1 study, sponsored by Massachusetts General Hospital.
NCT01388764 is a Phase 1 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 7 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01388764, a Phase 1 study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 7 participants
- Enrollment target
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.
Primary Outcome
MRI/MRS will be performed of the calf muscle in all subjects (N=8) to assess muscle signal abnormalities on MRI and creatine levels on MRS, done at the start of the study (Day 0) and at the end of the study (Day 30), after 30 days of L-arginine administration.
Interventions
- DRUG L-arginine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2012-01 |
| Est. Completion | 2012-05 |
| Phase | Phase 1 |
What the finished NCT01388764 record still lists
NCT01388764 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 1 intervention - of which L-arginine is the first listed.
NCT01388764 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01388764 about?
NCT01388764 is a clinical study titled "Safety, Tolerability and Effects of L-Arginine in Boys With Dystrophinopathy on Corticosteroids". 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.
What is the current status of trial NCT01388764?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 7 participants. The study started on 2012-01. Estimated completion is 2012-05.
What interventions are being tested in trial NCT01388764?
The interventions under investigation include: L-arginine (DRUG).
Who is sponsoring clinical trial NCT01388764?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01388764's enrollment target sits among peer trials
7 1972nd of 2000 higher than 27 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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