Oxidative Capacity and Exercise Tolerance in Ambulatory SMA

Study Identifier:
AAAQ9447
ClinicalTrials.gov Identifier:
NCT02895789
EudraCT Identifier:
N/A
EU CT Number:
N/A
Sponsor:
Columbia University
Study Complete

Study Details

Medical Condition
  • Spinal Muscular Atrophy Type III
  • All Spinal Muscular Atrophies
Study Drug
    Date
    Nov 2016 - Oct 2020
    Patient Requirements
    Sex: Female & Male
    Age: 8 - 55 Years
    Requirements Information
    Inclusion and Exclusion Criteria
    Inclusion Criteria
    • One of the following categories:
    • Genetic confirmation of SMA with laboratory documentation of homozygous deletion of SMN1 exon 7;
    • Genetic confirmation of mitochondrial myopathy or evidence from muscle biopsy confirming the diagnosis; or
    • Healthy individuals.
    • Able to walk independently at least 25 meters, and able to tread a stationary cycle ergometer.
    Exclusion Criteria
    • Unable to walk 25 meters independently.
    • Use of investigational medications intended for the treatment of SMA within 30 days prior to study entry.
    • The presence of any contraindication to exercise according the ACSM criteria.
    • Patients with and without Spinraza treatment are eligible.

    Protocol Summary

    This proposal will focus on (1) estimating oxidative capacity of specific muscle groups during exercise using near infrared spectroscopy and (2) describing body composition to better understand exercise capacity and mitochondrial function in ambulatory spinal muscular atrophy (SMA) patients and disease controls. It is a 6-month observational study including 14 ambulatory SMA patients, 14 ambulatory patients with mitochondrial myopathy, and 14 healthy controls.

    Trial Locations

    Location
    Status
    Location
    Columbia University Medical Center
    New York, New York, United States, 10032
    Status
    N/A

    Contact Cure SMA

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