Safety Study of Oral Sodium Phenylbutyrate in Subjects With ALS (Amyotrophic Lateral Sclerosis)
NCT ID: NCT00107770
Last Updated: 2010-01-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1/PHASE2
40 participants
INTERVENTIONAL
2005-04-30
2007-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Open-Label, Safety and Tolerability Extension Study of KNS-760704 in Amyotrophic Lateral Sclerosis (ALS) (CL211)
NCT00931944
Study to Evaluate Sodium Phenylbutyrate in Pre-symptomatic Infants With Spinal Muscular Atrophy
NCT00528268
Trial of Sodium Valproate in Amyotrophic Lateral Sclerosis
NCT00136110
A Study of NP001 in Subjects With Amyotrophic Lateral Sclerosis (ALS)
NCT01281631
A Long-term Extension Study of TCH346 and Placebo Administered Once Daily in Patients With Amyotrophic Lateral Sclerosis(ALS)
NCT00230074
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
STUDY DESIGN:
All research participants will take sodium phenylbutyrate for a total of 20 weeks. The dose of medication will be increased every 2 to 4 weeks until a maximum, easily tolerated dose is achieved (study maximum is 21 g/day).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
ALS patient
sodium phenylbutyrate
histone deacteylase inhibitor
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
sodium phenylbutyrate
histone deacteylase inhibitor
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* At least 18 years of age
* Women, who can become pregnant, must actively use effective birth control measures
Exclusion Criteria
Veterans only are eligible to participate at VA sites.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Muscular Dystrophy Association
OTHER
US Department of Veterans Affairs
FED
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Department of Veterans Affairs
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Robert Ferrante, PhD MSc
Role: PRINCIPAL_INVESTIGATOR
Edith Nourse Rogers Memorial Veterans Hospital, Bedford
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
VA Medical Center, Iowa City
Iowa City, Iowa, United States
VA Medical Center, Lexington
Lexington, Kentucky, United States
VA Maryland Health Care System, Baltimore
Baltimore, Maryland, United States
Edith Nourse Rogers Memorial Veterans Hospital, Bedford
Bedford, Massachusetts, United States
VA Medical Center, Jamaica Plain Campus
Boston, Massachusetts, United States
VA Medical Center, Syracuse
Syracuse, New York, United States
VA Medical Center, Durham
Durham, North Carolina, United States
VA Medical Center, Cincinnati
Cincinnati, Ohio, United States
VA Pittsburgh Health Care System
Pittsburgh, Pennsylvania, United States
Michael E. DeBakey VA Medical Center (152)
Houston, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
0015
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.