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NCT04202627 · ClinicalTrials.gov registry record
Biomarker Development in LGMD2i
A clinical trial of Muscular Dystrophies and Limb Girdle Muscular Dystrophy, sponsored by ML Bio Solutions.
- Completed
- Registry status
- 101
- Enrollment target
- 11
- Study locations
NCT04202627: Completed study of Muscular Dystrophies and Limb Girdle Muscular Dystrophy, sponsored by ML Bio Solutions.
NCT04202627 is a study of Muscular Dystrophies and Limb Girdle Muscular Dystrophy that has completed, run by ML Bio Solutions. The registered enrollment target is 101 participants, below the 890-participant average among 11 other Muscular Dystrophies trials with a reported enrollment target (89% lower). The trial reports 11 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04202627, a study of Muscular Dystrophies and Limb Girdle Muscular Dystrophy, has completed, sponsored by ML Bio Solutions.
- COMPLETED
- Registry status
- 101 participants
- Enrollment target
- 11
- Study locations
Study Summary
The overall goal of this natural history study is to define the key LGMD2i phenotypes as measured by standard clinical outcome assessments (COAs), and to validate a muscle biomarker for LGMD2i to support therapeutic development.
Primary Outcome
The 10 MWT will be used to determine the ambulatory Cohort for of all subjects. For the purposes of this study, the definitions for ambulation are as follows: * Cohort A: completes the 10 MWT unaided in ≥ 4 to ≤ 12 seconds * Cohort B: completes the walk unaided in \> 12 seconds or is non-ambulatory
Conditions Studied
Study Locations (11)
California
- University of California Irvine - Irvine
Colorado
- University of Colorado Anschutz Medical Campus - Aurora
Florida
- University of Florida - Gainesville
Iowa
- University of Iowa - Iowa City
Kansas
- University of Kansas Medical Center - Kansas City
Maryland
- Kennedy Krieger Institute - Baltimore
Missouri
- Washington University School of Medicine - St Louis
North Carolina
- Atrium Health - Charlotte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 101 participants |
| Start Date | 2019-12-01 |
| Est. Completion | 2022-10-10 |
What the finished NCT04202627 record still lists
NCT04202627 is an observational study that tracks outcomes without assigning an intervention. The registered 101 participants enrollment target is mid-sized for trials with a published cap, below the 890-participant average among 11 other Muscular Dystrophies trials with a reported enrollment target (89% lower).
The record links to 2 conditions, with Muscular Dystrophies appearing as the primary indexed condition, and to 0 interventions.
NCT04202627 lists 11 locations in 11 states (California, Colorado, Florida).
Frequently Asked Questions
What is clinical trial NCT04202627 about?
NCT04202627 is a clinical study titled "Biomarker Development in LGMD2i". The overall goal of this natural history study is to define the key LGMD2i phenotypes as measured by standard clinical outcome assessments (COAs), and to validate a muscle biomarker for LGMD2i to support therapeutic development.
What is the current status of trial NCT04202627?
This trial is currently completed. The enrollment target is 101 participants. The study started on 2019-12-01. Estimated completion is 2022-10-10.
What conditions does trial NCT04202627 study?
This clinical trial studies the following conditions: Muscular Dystrophies, Limb Girdle Muscular Dystrophy.
Who is sponsoring clinical trial NCT04202627?
This trial is sponsored by ML Bio Solutions, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04202627 being conducted?
This trial has 11 study locations across California, Colorado, Florida, Iowa, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04202627's enrollment target sits among peer trials
101 4th of 11 higher than 8 of 11 other Muscular Dystrophies trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Muscular Dystrophies 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.
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