Ignite Creation Date:
2024-05-05 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00481013
Status:
COMPLETED
Last Update Posted:
2016-12-06
First Post:
2007-05-30
Brief Title:
Valproic Acid in Ambulant Adults With Spinal Muscular Atrophy
Sponsor:
University of Utah
Organization:
University of Utah
Study Overview
Official Title:
Prospective Controlled Trial of Valproic Acid in Ambulant Adults With Spinal Muscular Atrophy VALIANTSMA Study
Status:
COMPLETED
Status Verified Date:
2016-12
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:
VALIANTSMA
Brief Summary:
The primary objective of this proposal is to determine whether oral VPA is effective in treating SMA in adult patients
Detailed Description:
Participation in this study entails six visits and seven to eight blood draws over 13 months Each visit entails a stay of two days and one night at the General Clinical Research Center GCRC
Subjects who live within driving distance will be allowed to participate in the study without an overnight stay through two consecutive outpatient visits All subjects will be evaluated at two screening visits 2-4 weeks apart to determine eligibility for participation Eligible subjects will be randomized to receive VPA or placebo for the first six months At the six-month visit patients will be evaluated and crossed over to the other regimen
Subjects who live within driving distance will be allowed to participate in the study without an overnight stay through two consecutive outpatient visits All subjects will be evaluated at two screening visits 2-4 weeks apart to determine eligibility for participation Eligible subjects will be randomized to receive VPA or placebo for the first six months At the six-month visit patients will be evaluated and crossed over to the other regimen
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