Clinical Trial: Study of Tetrathiomolybdate in Patients With Wilson Disease

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title:

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.

Detailed Summary:

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.

Sponsor: National Center for Research Resources (NCRR)

Current Primary Outcome:

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: National Center for Research Resources (NCRR)

Dates:
Date Received: October 18, 1999
Date Started: January 1994
Date Completion:
Last Updated: May 8, 2006
Last Verified: December 2003