Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004314
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-10-18
Brief Title:
Phase II Pilot Study of Aminoimidazole Carboxamide Riboside AICAR a Precursor of Purine Synthesis for Lesch-Nyhan Disease
Sponsor:
National Center for Research Resources NCRR
Organization:
Office of Rare Diseases ORD
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2000-01
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 effects of aminoimidazole carboxamide riboside AICAR on hematologic manifestations of Lesch-Nyhan disease
II Assess the behavioral and neurological benefits of AICAR in patients with Lesch-Nyhan disease
III Examine the effect of AICAR on purine production
II Assess the behavioral and neurological benefits of AICAR in patients with Lesch-Nyhan disease
III Examine the effect of AICAR on purine production
Detailed Description:
PROTOCOL OUTLINE
After a 3-day baseline patients are treated with aminoimidazole carboxamide riboside AICAR by continuous infusion for 12 days Concurrent allopurinol and folate are allowed
After a 3-day baseline patients are treated with aminoimidazole carboxamide riboside AICAR by continuous infusion for 12 days Concurrent allopurinol and folate are allowed
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-733 | None | None | None |