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

Completed

Conditions studied: Muscular Atrophy, Spinal

In brief

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.

Key facts

Study ID

NCT01910168

Run by

Hoffmann-La Roche

People needed

36

Starts

2013-08-01

Expected to finish

2014-02-01

Last updated by the study team

2016-11-02

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Study site — Kalamazoo, Michigan, United States
• Study site — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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