Study of Tetrathiomolybdate in Patients With Wilson Disease
Evaluate the safety and efficacy of ammonium tetrathiomolybdate alone and compared with trientine therapy as initial treatment in patients with Wilson disease presenting neurologically.
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Study Start Date:||January 1994|
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.
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States, 48109|
|Study Chair:||George J. Brewer||University of Michigan|