Determinants of Disease Severity in Amyotrophic Lateral Sclerosis

This study is ongoing, but not recruiting participants.

First Received: October 18, 1999 Last Updated: June 23, 2005 History of Changes

Sponsor:	National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator:	Massachusetts General Hospital
Information provided by:	Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:	NCT00004457

Purpose

OBJECTIVES:

I. Determine specific clinical features, molecular abnormalities, and laboratory-based biological markers of free radical stress that are associated with amyotrophic lateral sclerosis and influence disease severity.

Condition
Amyotrophic Lateral Sclerosis

Study Type:	Observational
Study Design:	Screening, Defined Population, Prospective Study

Resource links provided by NLM:

Genetics Home Reference related topics: amyotrophic lateral sclerosis

MedlinePlus related topics: Amyotrophic Lateral Sclerosis

U.S. FDA Resources

Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment:	75
Study Start Date:	March 1998

Detailed Description:

PROTOCOL OUTLINE: This is a screening and diagnostic study. Blood and urine samples are collected from patients every 2 months for 1 year. All samples are evaluated for measures of free radical damage and levels of the body's own antioxidant activity.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Clinically diagnosed probable or definite, sporadic or familial amyotrophic lateral sclerosis

--Patient Characteristics-- Pulmonary: No artificial ventilation required Other: No other neurodegenerative diseases No concurrent or history of unstable medical illness

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004457

Sponsors and Collaborators

National Institute of Neurological Disorders and Stroke (NINDS)

Massachusetts General Hospital

Investigators

Study Chair:

Merit E. Cudkowicz

Massachusetts General Hospital

More Information

No publications provided

Study ID Numbers:	199/13650, MGH-97-7231, MGH-1K08NS01896
Study First Received:	October 18, 1999
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00004457 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by Office of Rare Diseases (ORD):

amyotrophic lateral sclerosis
motor neuron disease
neurologic and psychiatric disorders
rare disease

Additional relevant MeSH terms:

Pathologic Processes
Neuromuscular Diseases
Spinal Cord Diseases
Amyotrophic Lateral Sclerosis
Nervous System Diseases

Central Nervous System Diseases
Sclerosis
Neurodegenerative Diseases
Motor Neuron Disease

ClinicalTrials.gov processed this record on November 09, 2009