A Multicenter Study for the Discovery and Validation of ALS Biomarkers

Study Purpose:

The purpose of this study is to collect biofluid samples for the banking and usage in ALS research. Through comparison of these samples, 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.

Study Status:

Not recruiting

Disease:

Amyotrophic Lateral Sclerosis , Nervous System Diseases , Sclerosis , Motor Neuron Disease , Spinal Cord Diseases , Central Nervous System Diseases , Neurodegenerative Diseases , Neuromuscular Diseases , ALS

Study Type:

Observational

Type of Intervention:

N/A

Intervention Name:

N/A

Placebo:

N/A

Phase:

N/A

Study Chair(s)/Principal Investigator(s):

James D. Berry, MD, MPH, Massachusetts General Hospital

Clinicaltrials.gov ID:

NCT01495390

Neals Affiliated?

Yes

Coordinating Center Contact Information

Mass General Hospital

Neurological Clinical Research Institute (NCRI)
Boston, Massachusetts, 02114 United States

Full 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.

Study Sponsor:

Massachusetts General Hospital

Participant Duration:

up to 36 months

Estimated Enrollment:

139

Estimated Study Start Date:

07 / 31 / 2011

Estimated Study Completion Date:

12 / 31 / 2016

Posting Last Modified Date:

05 / 30 / 2017

Date Study Added to neals.org:

12 / 20 / 2011

Minimum Age:

18 Years

Maximum Age:

N/A

Can participants use Riluzole?

Yes

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.

Barrow Neurological Institute

Phoenix, Arizona 85013
United States

Mayo Clinic Jacksonville

Jacksonville, Florida 32224
United States

Emory University

Atlanta, Georgia 30322
United States

Massachusetts General Hospital

Boston, Massachusetts 02114
United States

University of Massachusetts Medical Center

Worcester, Massachusetts 01655
United States

University of Pittsburgh

Pittsburgh, Pennsylvania 15213
United States