Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004339
Status:
COMPLETED
Last Update Posted:
2006-05-09
First Post:
1999-10-18
Brief Title:
Study of Tetrathiomolybdate in Patients With Wilson Disease
Sponsor:
National Center for Research Resources NCRR
Organization:
National Center for Research Resources NCRR
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2003-12
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
Evaluate the safety and efficacy of ammonium tetrathiomolybdate alone and compared with trientine therapy as initial treatment in patients with Wilson disease presenting neurologically
Evaluate the safety and efficacy of ammonium tetrathiomolybdate alone and compared with trientine therapy as initial treatment in patients with Wilson disease presenting neurologically
Detailed Description:
PROTOCOL OUTLINE This a double blind randomized study Patients are randomized into one of two treatment arms
Arm I Patients receive tetrathiomolybdate TM 3 times a day with meals and 3 times a day between meals for 8 weeks in the absence of neurologic deterioration or unacceptable toxicity
Arm II Patients receive trientine therapy for 8 weeks in the absence of neurologic deterioration and unacceptable toxicity
Additional therapy off study Patients in the TM group may receive maintenance zinc while those in the trientine group may continue on trientine or switch to zinc
Arm I Patients receive tetrathiomolybdate TM 3 times a day with meals and 3 times a day between meals for 8 weeks in the absence of neurologic deterioration or unacceptable toxicity
Arm II Patients receive trientine therapy for 8 weeks in the absence of neurologic deterioration and unacceptable toxicity
Additional therapy off study Patients in the TM group may receive maintenance zinc while those in the trientine group may continue on trientine or switch to zinc
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 |
|---|---|---|---|
| UMICH-FDU000505 | None | None | None |
| UMMC-801 | None | None | None |