Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004770
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2000-02-24
Brief Title:
Pilot Compassionate Use Study of Thioctic Acid Treatment in Mitochondrial Myopathy
Sponsor:
National Center for Research Resources NCRR
Organization:
Office of Rare Diseases ORD
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2001-12
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:
None
Brief Summary:
OBJECTIVES
I Assess the efficacy of thioctic acid in treating a single patient with mitochondrial myopathy
I Assess the efficacy of thioctic acid in treating a single patient with mitochondrial myopathy
Detailed Description:
PROTOCOL OUTLINE The patient receives one thioctic acid tablet 3 times a day If patient experiences no side effects after 1 week 2 tablets are administered and given 3 times a day over 3 months for compassionate use
The patient is followed at weeks 3 8 and 12
The patient is followed at weeks 3 8 and 12
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 |
|---|---|---|---|
| URMC-5231 | None | None | None |