A Study to Collect Blood Samples From Patients With Spinal Muscular Atrophy for Biomarker Analysis

Study Identifier:
BE29002
ClinicalTrials.gov Identifier:
NCT01910168
EudraCT Identifier:
N/A
EU CT Number:
N/A
Sponsor:
Hoffmann-La Roche
Study Complete

Study Details

Medical Condition
  • All Spinal Muscular Atrophies
Study Drug
    Date
    Aug 2013 - Feb 2014
    Patient Requirements
    Sex: Female & Male
    Age: N/A
    Requirements Information
    Inclusion and Exclusion Criteria
    Inclusion Criteria
    • Self-identified as 5q-autosomal recessive spinal muscular atrophy (SMA) type I, II or III as judged by their neurologist upon diagnosis
    • Ability and willingness to provide blood samples
    • Willingness (by the patient or patient's parents or legal guardian) to complete to their best ability a questionnaire which requests specific clinical and genetic information
    • Able to participate and willing to give written informed consent or assent. Informed consent will be obtained from the patient, or the patient's parent or legal guardian.
    Exclusion Criteria
    • Any known genetic condition other than spinal muscular atrophy, unless it is not interfering with the purpose of this study based on the Sponsor's judgment
    • Participation in a clinical trial (except observational studies) within the previous 14 days
    • Donation of blood or significant blood loss within three months prior to screening
    • Concomitant disease or condition that could interfere with, or treatment of which might interfere with, the conduct of this study, or that would, in the opinion of the investigator, pose an unacceptable risk to the patient in this study

    Protocol Summary

    In this single center study blood samples for biomarker analysis will be collected from patients with spinal muscular atrophy. Up to 21 mL blood will be drawn from eligible patients at a single visit.

    Trial Locations

    Location
    Status
    Location
    Kalamazoo, Michigan, United States, 49007
    Status
    N/A
    Location
    Salt Lake City, Utah, United States, 84108
    Status
    N/A

    Contact Cure SMA

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