NCT00004339

Study of Tetrathiomolybdate in Patients With Wilson Disease

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 90 (planned)
• Sponsor: National Center for Research Resources (NCRR) · NIH
• Sex: All
• Age: 0 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Wilson Disease

Interventions

Type	Name	Description
DRUG	tetrathiomolybdate
DRUG	trientine

Timeline

• Start date: 1994-01-01
• First posted: 1999-10-19
• Last updated: 2006-05-09

Locations

1 site across 1 country: United States