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Determinants of Disease Severity in Amyotrophic Lateral Sclerosis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2001 by Office of Rare Diseases (ORD).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Massachusetts General Hospital
Information provided by:
Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:
NCT00004457
First received: October 18, 1999
Last updated: June 23, 2005
Last verified: January 2001
History of Changes
  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: Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Prospective

Resource links provided by NLM:

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

ClinicalTrials.gov Identifier: NCT00004457     History of Changes
Other Study ID Numbers: 199/13650, MGH-97-7231, MGH-1K08NS01896
Study First Received: October 18, 1999
Last Updated: June 23, 2005
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:
Amyotrophic Lateral Sclerosis
Sclerosis
Motor Neuron Disease
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
 Neurodegenerative Diseases
TDP-43 Proteinopathies
Neuromuscular Diseases
Proteostasis Deficiencies
Metabolic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013