- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01920828
Gait Analysis in MPS IVA
Gait Analysis in Patients With MPS IVA Treated With Enzyme Replacement Therapy
Study Overview
Status
Conditions
Detailed Description
The purpose of this 3-year study is to conduct a longitudinal investigation using motion analysis of gait to objectively and quantitatively assess gait characteristics of MPS IVA patients. Data documenting gait characteristics and abnormalities will be gathered in patients initiating enzyme replacement therapy.
Inclusion criteria Individuals with MPS IVA diagnosed by enzyme or molecular studies Exclusion Criteria Individual with MPS IVA previously enrolled in BMN-110 Individual is non-ambulatory The individual is unable to complete longitudinal study visits at least yearly
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Oregon
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Portland, Oregon, United States, 97239
- Oregon Health and Science University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
-Diagnosis of MPS IVA
Exclusion Criteria:
Non-ambulatory
- Previous enrolled in clinical trial BMN-110
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measurable changes in gait
Time Frame: 36 months
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Data acquired on patients will be compared with age-matched standardized norms.
The normal data is available from a pre-existing Gait Repository, a collection of gait parameters in children without a specific diagnosis studied at Oregon Health and Science University.
The results will be converted to centile charts with the aid of a biostatistician.
Centile charts will be used to track statistical changes over time in the following gait parameters including but not exclusive to: velocity, cadence, step length, and base of support.
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36 months
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Metabolic Diseases
- Genetic Diseases, Inborn
- Musculoskeletal Diseases
- Connective Tissue Diseases
- Bone Diseases
- Carbohydrate Metabolism, Inborn Errors
- Metabolism, Inborn Errors
- Lysosomal Storage Diseases
- Mucinoses
- Bone Diseases, Developmental
- Mucopolysaccharidoses
- Osteochondrodysplasias
- Mucopolysaccharidosis IV
Other Study ID Numbers
- OregonHSU-8833
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on MPS IVA
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University of California, San FranciscoRecruiting
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BioMarin PharmaceuticalTerminatedMorquio A Syndrome | MPS IV A | Mucopolysaccharidosis IVAUnited Kingdom
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Children's Hospital of Eastern OntarioCompleted