Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00107770
Status:
COMPLETED
Last Update Posted:
2010-01-11
First Post:
2005-04-07
Brief Title:
Safety Study of Oral Sodium Phenylbutyrate in Subjects With ALS Amyotrophic Lateral Sclerosis
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Safety and Dose Escalating Study of Oral Sodium Phenylbutyrate in Subjects With Amyotrophic Lateral Sclerosis
Status:
COMPLETED
Status Verified Date:
2008-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 changes in DNA the bodys genetic material Drugs such as sodium phenylbutyrate NaPB can increase the expression of genes block how the motor nerve cells in ALS die and may prove to be an effective therapy for ALS NaPB has shown an improvement in survival in mice with conditions similar to ALS
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 gday
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 gday
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None