Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004493
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
1999-10-18
Brief Title:
Phase II Pilot Randomized Study of Sodium Dichloroacetate in Patients With Congenital Lactic Acidemia
Sponsor:
University of California San Diego
Organization:
FDA Office of Orphan Products Development
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2000-05
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:
OBJECTIVES I Determine the pharmacokinetics of sodium dichloroacetate DCA in patients with congenital lactic acidemia
II Determine the efficacy of DCA in decreasing the frequency andor severity of acute episodes of acidotic illness improving linear growth improving neurological or developmental function or slowing neurological or developmental deterioration in these patients
II Determine the efficacy of DCA in decreasing the frequency andor severity of acute episodes of acidotic illness improving linear growth improving neurological or developmental function or slowing neurological or developmental deterioration in these patients
Detailed Description:
PROTOCOL OUTLINE This is a randomized double blind cross over study Patients are randomized to start with one of two different doses of sodium dichloroacetate DCA
Patients receive one of two doses of oral DCA for 6 months then switch to the alternate dose for 6 months This course is repeated once
Patients are followed for up to 2 years
Completion date provided represents the completion date of the grant per OOPD records
Patients receive one of two doses of oral DCA for 6 months then switch to the alternate dose for 6 months This course is repeated once
Patients are followed for up to 2 years
Completion date provided represents the completion date of the grant per OOPD records
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UCSD-FDR001481 | None | None | None |