Expired Study
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Ann Arbor, Michigan 48109


Purpose:

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.


Study 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.


Criteria:

PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Wilson disease presenting with neurologic or psychiatric symptoms - No concurrent seizure activity - No white matter lesions on brain magnetic resonance imaging --Prior/Concurrent Therapy-- - No more than 2 weeks of prior therapy - No penicillamine or trientine for longer than 2 weeks --Patient Characteristics-- - Hepatic: No severe hepatic failure - Other: No psychiatric or medical contraindication to protocol therapy - Not pregnant


NCT ID:

NCT00004339


Primary Contact:

Study Chair
George J. Brewer
University of Michigan


Backup Contact:

N/A


Location Contact:

Ann Arbor, Michigan 48109
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 19, 2017

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