Safety Study of Oral Sodium Phenylbutyrate in Subjects With ALS (Amyotrophic Lateral Sclerosis)
Safety and Dose Escalating Study of Oral Sodium Phenylbutyrate in Subjects With Amyotrophic Lateral Sclerosis
1 other identifier
interventional
40
1 country
10
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 side effects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Apr 2005
Typical duration for phase_1
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2005
CompletedFirst Submitted
Initial submission to the registry
April 7, 2005
CompletedFirst Posted
Study publicly available on registry
April 8, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2007
CompletedJanuary 11, 2010
October 1, 2008
1.6 years
April 7, 2005
January 8, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
safety and tolerability
20 weeks
Secondary Outcomes (2)
The number of side effects at each dosage, including abnormalities in vital signs, physical examination, blood tests and EKGs, change in vital capacity (breathing function) and ALS functional rating scale
Relationship between blood levels and sodium phenylbutyrate dosage
Study Arms (1)
1
OTHERALS patient
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosed with ALS
- At least 18 years of age
- Women, who can become pregnant, must actively use effective birth control measures
You may not qualify if:
- Must not have any other neurological (nervous system) disease
- Veterans only are eligible to participate at VA sites.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- US Department of Veterans Affairslead
- Muscular Dystrophy Associationcollaborator
Study Sites (10)
VA Medical Center, Iowa City
Iowa City, Iowa, 52246-2208, United States
VA Medical Center, Lexington
Lexington, Kentucky, 40502, United States
VA Maryland Health Care System, Baltimore
Baltimore, Maryland, 21201, United States
Edith Nourse Rogers Memorial Veterans Hospital, Bedford
Bedford, Massachusetts, 01730, United States
VA Medical Center, Jamaica Plain Campus
Boston, Massachusetts, 02130, United States
VA Medical Center, Syracuse
Syracuse, New York, 13210, United States
VA Medical Center, Durham
Durham, North Carolina, 27705, United States
VA Medical Center, Cincinnati
Cincinnati, Ohio, 45220, United States
VA Pittsburgh Health Care System
Pittsburgh, Pennsylvania, 15240, United States
Michael E. DeBakey VA Medical Center (152)
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Ferrante, PhD MSc
Edith Nourse Rogers Memorial Veterans Hospital, Bedford
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- FED
Study Record Dates
First Submitted
April 7, 2005
First Posted
April 8, 2005
Study Start
April 1, 2005
Primary Completion
November 1, 2006
Study Completion
September 1, 2007
Last Updated
January 11, 2010
Record last verified: 2008-10