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NCT00004457 Clinical Trial

Determinants of Disease Severity in Amyotrophic Lateral Sclerosis

Amyotrophic Lateral Sclerosis Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00004457
Other study ID # 199/13650
Secondary ID MGH-97-7231MGH-1
Status Active, not recruiting
Phase N/A
First received October 18, 1999
Last updated June 23, 2005
Start date March 1998

Study information
Verified date January 2001
Source Office of Rare Diseases (ORD)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 75
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Defined Population, Primary Purpose: Screening, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
National Institute of Neurological Disorders and Stroke (NINDS) Massachusetts General Hospital
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