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NCT01437345 · ClinicalTrials.gov registry record

A Multicenter Collaborative Study on the Clinical Features, Expression Profiling, and Quality of Life of Infantile Onset FSHD

A clinical trial, sponsored by Cooperative International Neuromuscular Research Group.

Completed
Registry status
53
Enrollment target

NCT01437345: Completed study, sponsored by Cooperative International Neuromuscular Research Group.

NCT01437345 is a clinical trial that has completed, run by Cooperative International Neuromuscular Research Group. The registered enrollment target is 53 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01437345 has completed, sponsored by Cooperative International Neuromuscular Research Group.

COMPLETED
Registry status
53 participants
Enrollment target

Study Summary

This study is an observational study that aims to advance our knowledge on infantile onset FSHD. The study will include 50 participants of all ages who have presented with symptoms of FSHD between birth and 10 years of age. Study participation will involve a single day of assessments at one of the participating CINRG centers (to include physical exam, cognitive testing, eye exam, hearing test, strength testing and speech evaluations). The procedures may be split over additional days for scheduling purposes.

Primary Outcome

1. Establish a standardized muscle testing protocol including both manual and quantitative muscle testing as well as function testing for use in children and adults with infantile onset FSHD. 2. To describe the clinical phenotypes of infantile FSHD; separately in the early infantile group (onset before age 5) and late onset group (onset between 5 and 10 years of age). 3. To evaluate the impact of physical impairment, secondary health conditions, activity limitations and disability caused by FSHD

Trial Details

FieldValue
Enrollment Target 53 participants
Start Date 2012-07
Est. Completion 2017-08

What the finished NCT01437345 record still lists

NCT01437345 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 53 participants, a relatively small participant target.

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

NCT01437345 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01437345 about?

NCT01437345 is a clinical study titled "A Multicenter Collaborative Study on the Clinical Features, Expression Profiling, and Quality of Life of Infantile Onset FSHD". This study is an observational study that aims to advance our knowledge on infantile onset FSHD. The study will include 50 participants of all ages who have presented with symptoms of FSHD between birth and 10 years of age. Study participation will involve a single day of assessments at one of the p...

What is the current status of trial NCT01437345?

This trial is currently completed. The enrollment target is 53 participants. The study started on 2012-07. Estimated completion is 2017-08.

Who is sponsoring clinical trial NCT01437345?

This trial is sponsored by Cooperative International Neuromuscular Research Group, which has 13 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT01437345, the US trial registry maintained by the National Library of Medicine. NCT01437345 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.