Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004658
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2000-02-24
Brief Title:
Phase II Study of Ribose Uridine and Thymidine for a Complex Syndrome Involving Excessive 5-Nucleotidase Activity
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 Evaluate the efficacy of oral ribose in patients with a complex 5-nucleotidase syndrome who have not received uridine UR and thymidine TDR
II Evaluate the efficacy of URoral ribose and URTDR III Evaluate the efficacy of oral ribose given in combination with URTDR
II Evaluate the efficacy of URoral ribose and URTDR III Evaluate the efficacy of oral ribose given in combination with URTDR
Detailed Description:
PROTOCOL OUTLINE Newly identified patients receive ribose daily for 8 weeks Patients who improve continue therapy If improvement then reaches a plateau uridine UR and thymidine TDR are added to the regimen
Patients who receive no benefit after 8 weeks of ribose are treated with URTDR Patients who improve after 8 weeks of this combination continue therapy
Ribose is added to the treatment regimen for patients on URTDR at entry At maximal improvement TDR and UR are sequentially tapered
Patients who receive no benefit after 8 weeks of ribose are treated with URTDR Patients who improve after 8 weeks of this combination continue therapy
Ribose is added to the treatment regimen for patients on URTDR at entry At maximal improvement TDR and UR are sequentially tapered
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-782 | None | None | None |