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A Multicenter Study for the Discovery and Validation of ALS Biomarkers

 
Study Focus:
The purpose of this study is to collect biofluid samples for the banking and usage in ALS research.
Disease:
Amyotrophic Lateral Sclerosis (ALS), Sporadic ALS, Familial ALS
Study Category:
Biomarkers/imaging
Study Status:
Active, currently recruiting
Phase:
Not Applicable
Type:
Observational Study
Funding Source:
ALS Therapy Alliance
Study Chair(s)/Principal Investigator(s):
Merit Cudkowicz, MD, MSc (Massachusetts General Hospital)
James D. Berry, MD, MPH (Massachusetts General Hospital)
Robert Bowser, PhD (Barrow Neurological Institute)
Robert Brown, MD, D. Phil (UMASS)
Kevin Boylan, MD (Mayo Clinic Jacksonville)
Jonathan Glass, MD (Emory University)
David Lacomis, MD (University of Pittsburgh)
Clinicaltrials.gov ID:
NCT01495390
NEALS Affiliated?
Yes
Study Summary:
The purpose of the research study is to collect blood samples and cerebrospinal fluid (CSF) from people with amyotrophic lateral sclerosis (ALS). These samples will be collected approximately every 4 months. Through comparison of these specimens, the researchers hope to learn more about the underlying cause of ALS, as well as find unique biological markers, which could be used to develop new therapies.
Participant Duration:
up to 36 months
# of Subjects:
up to 250
Enrollment Start Date:
08/01/2011
Enrollment End Date:
12/01/2016
Posting Last Modified Date:
02/01/2016
Date Study Added to alsconsortium.org:
12/21/2011
More information:
https://clinicalt...CT01495390&rank=1
Eligibility Criteria
Gender:
Male & Female
Minimum Age:
18
Min Vital Capacity (% predicted normal):
50%
Time since Symptom Onset:
Not applicable
Time since Diagnosis:
Not applicable
Can participants use Riluzole?
Yes
Coordinating Center
Contact Information
Daniela Grasso
dgrasso@mgh.harvard.edu
617-726-0842
Mass General Hospital
Neurological Clinical Research Institute (NCRI) 165 Cambridge Street, 6th Floor
Boston, Massachusetts 02114
UNITED STATES
Other Eligibility Criteria:
Inclusion Criteria:

Age 18 or older
Diagnosis of suspected, possible, probable or definite ALS according to El Escorial Criteria
Vital capacity (VC) at least 50 percent predicted
Able to undergo multiple lumbar punctures

Exclusion Criteria:

Abnormal CSF pressure or intracranial/intraspinal tumors
Use of anticoagulant medication that cannot be safely withheld
Bleeding disorders

This is a partial listing.

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