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NCT01451281 · ClinicalTrials.gov registry record

Studying Skeletal Muscle, Heart, and Diaphragm Imaging in Boys With Duchenne Muscular Dystrophy

A clinical trial, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).

Completed
Registry status
35
Enrollment target

NCT01451281: Completed study, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).

NCT01451281 is a clinical trial that has completed, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 35 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01451281 has completed, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).

COMPLETED
Registry status
35 participants
Enrollment target

Study Summary

Background: \- Duchenne muscular dystrophy (DMD) is a disease in which the muscles are unable to make the protein dystrophin. Without this protein, the muscles become gradually weaker. A new medicine called GSK2402968 is being tested to see if it can help prevent or slow down this loss of muscle strength. In this study, boys with DMD and healthy volunteers will have different types of imaging studies to see which ones provide the best images of the muscles. This information will help researchers use these imaging techniques to test the safety and effectiveness of GSK2402968 and other agents. Objectives: \- To test magnetic resonance imaging and ultrasound techniques that can detect changes in muscles of boys with DMD. Eligibility: * Boys who have DMD and are in the GSK2402968 drug test study. * Healthy boys of the same age as the above study participants. Design: * Participants will be screened with a medical history and physical exam. * Healthy volunteers will have one 2-hour visit with three tests. Magnetic resonance imaging (MRI) scans of the skeletal muscles and heart and diaphragm muscles will be carried out. Muscle ultrasound imaging of leg and arm muscles will also be done. Participants should not perform heavy physical activity like school sports or long walks during the week before the visit. * Participants in the GSK2402968 study will have the same series of tests as the healthy volunteers. The tests will be given during the study screening phase. They will be repeated after 3 months and 6 months of receiving the study agent (GSK2402968 or placebo) and at 6 months after stopping the GSK study.

Trial Details

FieldValue
Enrollment Target 35 participants
Start Date 2011-09-15
Est. Completion 2019-05-20

What the finished NCT01451281 record still lists

NCT01451281 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 35 participants, a relatively small participant target.

The record links to 0 conditions, and to 0 interventions.

NCT01451281 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01451281 about?

NCT01451281 is a clinical study titled "Studying Skeletal Muscle, Heart, and Diaphragm Imaging in Boys With Duchenne Muscular Dystrophy". Background: \- Duchenne muscular dystrophy (DMD) is a disease in which the muscles are unable to make the protein dystrophin. Without this protein, the muscles become gradually weaker. A new medicine called GSK2402968 is being tested to see if it can help prevent or slow down this loss of muscle st...

What is the current status of trial NCT01451281?

This trial is currently completed. The enrollment target is 35 participants. The study started on 2011-09-15. Estimated completion is 2019-05-20.

Who is sponsoring clinical trial NCT01451281?

This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT01451281, the US trial registry maintained by the National Library of Medicine. NCT01451281 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.