A Longitudinal Study of Amyotrophic Lateral Sclerosis (ALS) Biomarkers

NCT ID: NCT01495390

Last Updated: 2017-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

139 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-11-30

Study Completion Date

2016-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

ALS Association

OTHER

Sponsor Role collaborator

ALS Finding a Cure

OTHER

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

James D. Berry MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

James D. Berry, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Barrow Neurological Institute

Phoenix, Arizona, United States

Site Status

Mayo Clinic Jacksonville

Jacksonville, Florida, United States

Site Status

Emory University

Atlanta, Georgia, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

University of Massachusetts Medical Center

Worcester, Massachusetts, United States

Site Status

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Related Links

Access external resources that provide additional context or updates about the study.

http://www.alsconsortium.org

Northeast ALS Consortium Website

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BIO-ALS-02

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

PREVENT ALL ALS Study
NCT06581861 RECRUITING
Multicenter ALS Imaging Study
NCT06735014 RECRUITING
ALS Research Collaborative
NCT06885918 RECRUITING
ASSESS ALL ALS Study
NCT06578195 RECRUITING