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NCT01851447 · ClinicalTrials.gov registry record
Skeletal Muscle Biomarkers in People With Fragile Sarcolemmal Muscular Dystrophy
A clinical trial of Genetic Disorder, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- Active
- Registry status
- 11
- Enrollment target
- 1
- Study location
NCT01851447: Active study of Genetic Disorder, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
NCT01851447 is a study of Genetic Disorder that is active but no longer recruiting, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The registered enrollment target is 11 participants, below the 22,195-participant average among 5 other Genetic Disorder trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01851447, a study of Genetic Disorder, is active but no longer recruiting, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- ACTIVE NOT RECRUITING
- Registry status
- 11 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: \- Some kinds of muscular dystrophy affect the skeletal muscle membrane. In these conditions, the muscle membrane is more fragile. This affects how the muscles contract and relax, which causes movement problems. Researchers are looking at several muscle enzymes, or chemicals that affect how muscle cells function. By studying changes in these enzymes, they may be able to better understand how muscular dystrophy affects the cells. Researchers want to collect biomarkers (chemicals from blood samples) from people with fragile sarcolemmal muscular dystrophy. This information may provide better treatments for this condition. Objectives: \- To study biomarkers that may affect the muscles of people with fragile sarcolemmal muscular dystrophy. Eligibility: \- Individuals at least 18 years of age with fragile sarcolemmal muscular dystrophy. Design: * Participants will be screened with a medical history and physical exam. * Participants will be asked to come for four visits to the National Institutes of Health Clinical Center. The visits will be at least 2 months apart. Each visit will require participants to stay for 5 days at the clinical center. * During each visit, participants will provide frequent small blood samples. These samples will be collected while at rest and after physical exercise. * Participants will also have a physical therapy assessment. They will perform standard motor function tests and imaging tests (MRI, MRS). These tests may take up to 1 hour each time. * Treatment will not be provided as part of this study.
Primary Outcome
biomarker levels (CK, ALT, AST...) increases
Conditions Studied
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2014-11-03 |
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)305 total trials
What the registry record for NCT01851447 still lists
NCT01851447 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 22,195-participant average among 5 other Genetic Disorder trials with a reported enrollment target (100% lower).
The record links to 1 condition, with Genetic Disorder appearing as the primary indexed condition, and to 0 interventions.
NCT01851447 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT01851447 about?
NCT01851447 is a clinical study titled "Skeletal Muscle Biomarkers in People With Fragile Sarcolemmal Muscular Dystrophy". Background: \- Some kinds of muscular dystrophy affect the skeletal muscle membrane. In these conditions, the muscle membrane is more fragile. This affects how the muscles contract and relax, which causes movement problems. Researchers are looking at several muscle enzymes, or chemicals that affect...
What is the current status of trial NCT01851447?
This trial is currently active not recruiting. The enrollment target is 11 participants. The study started on 2014-11-03.
What conditions does trial NCT01851447 study?
This clinical trial studies the following conditions: Genetic Disorder.
Who is sponsoring clinical trial NCT01851447?
This trial is sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01851447 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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