Determinants of Disease Severity in Amyotrophic Lateral Sclerosis - Tabular View

Tracking Information

First Received Date ^ICMJE

October 18, 1999

Last Updated Date

June 23, 2005

Start Date ^ICMJE

March 1998

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00004457 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Determinants of Disease Severity in Amyotrophic Lateral Sclerosis

Official Title ^ICMJE

Brief 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.

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.

Study Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Screening, Defined Population, Prospective Study

Condition ^ICMJE

Amyotrophic Lateral Sclerosis

Intervention ^ICMJE

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00004457

Responsible Party

Study ID Numbers ^ICMJE

199/13650, MGH-97-7231, MGH-1K08NS01896

Study Sponsor ^ICMJE

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborators ^ICMJE

Massachusetts General Hospital

Investigators ^ICMJE

Study Chair:

Merit E. Cudkowicz

Massachusetts General Hospital

Information Provided By

Office of Rare Diseases (ORD)

Verification Date

January 2001

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP