Status:
COMPLETED
Safety Study of Oral Sodium Phenylbutyrate in Subjects With ALS (Amyotrophic Lateral Sclerosis)
Lead Sponsor:
US Department of Veterans Affairs
Collaborating Sponsors:
Muscular Dystrophy Association
Conditions:
Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of the study is to evaluate the safety of sodium phenylbutyrate (NaPB) treatment in subjects with amyotrophic lateral sclerosis (ALS) and the ability to take this medication without major ...
Detailed Description
Although it is known that nerve cells die in the brains and spinal cords of patients who have ALS, the cause of the cell death is unknown. There is evidence that this cell death may be caused by chang...
Eligibility Criteria
Inclusion
- Diagnosed with ALS
- At least 18 years of age
- Women, who can become pregnant, must actively use effective birth control measures
Exclusion
- Must not have any other neurological (nervous system) disease
- Veterans only are eligible to participate at VA sites.
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00107770
Start Date
April 1 2005
End Date
September 1 2007
Last Update
January 11 2010
Active Locations (10)
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1
VA Medical Center, Iowa City
Iowa City, Iowa, United States, 52246-2208
2
VA Medical Center, Lexington
Lexington, Kentucky, United States, 40502
3
VA Maryland Health Care System, Baltimore
Baltimore, Maryland, United States, 21201
4
Edith Nourse Rogers Memorial Veterans Hospital, Bedford
Bedford, Massachusetts, United States, 01730