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Determinants of Disease Severity in Amyotrophic Lateral Sclerosis



Determinants of Disease Severity in Amyotrophic Lateral Sclerosis

For Condition: Amyotrophic Lateral Sclerosis
Status: No longer recruiting
Sponsor(s): National Institute of Neurological Disorders and Stroke (NINDS) , Massachusetts General Hospital
Synopsis: 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.
Details: 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:
Study Type:  Observational, Screening, Defined Population, Prospective Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry 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
Total Enrollment: 75

Location and Contact Information:

Overall Study Official:
MeritCudkowicz,  Study Chair,  Massachusetts General Hospital


Additional Information:
Study ID Numbers:  199/13650;  MGH-97-7231,MGH-1K08NS01896
Study Start Date: March 1998
Record last reviewed: January 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004457

Other Amyotrophic Lateral Sclerosis Studies:
1. Phase II Study of Leuprolide and Testosterone for Men with Kennedy's Disease or Other Motor Neuron Disease

2. Study evaluating 4 oral doses of TCH346 and placebo administered once daily in patients with Amyotrophic Lateral Sclerosis (ALS)

3. Safety/Efficacy of AVP-923 in the Treatment of Emotional Lability (Uncontrolled Crying & Laughing) in Patients With ALS

4. Nuclear Magnetic Spectroscopy Imaging to Evaluate Primary Lateral Sclerosis, Hereditary Spastic Paraplegia and Amyotrophic Lateral Sclerosis

5. IGF-1/ALS Trial

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