Study of Tetrathiomolybdate in Patients With Wilson Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00004339|
Recruitment Status : Completed
First Posted : October 19, 1999
Last Update Posted : May 9, 2006
Evaluate the safety and efficacy of ammonium tetrathiomolybdate alone and compared with trientine therapy as initial treatment in patients with Wilson disease presenting neurologically.
|Condition or disease||Intervention/treatment||Phase|
|Wilson Disease||Drug: tetrathiomolybdate Drug: trientine||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Study Start Date :||January 1994|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004339
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States, 48109|
|Study Chair:||George J. Brewer||University of Michigan|