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Study of Tetrathiomolybdate in Patients With Wilson Disease



Study of Tetrathiomolybdate in Patients With Wilson Disease

For Condition: Wilson Disease
Status: Completed
Sponsor(s): National Center for Research Resources (NCRR) , University of Michigan
Synopsis: 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.
Details: 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.
Eligibility:
Study Type:
  Interventional, Treatment, Randomized, Double-Blind
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry 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
Total Enrollment: 90

Location and Contact Information:

Overall Study Official:
GeorgeBrewer,  Study Chair,  University of Michigan

University of Michigan
Ann Arbor,  Michigan,  48109
United States
 


Additional Information:
Study ID Numbers:
  NCRR-M01RR00042-1850;  UMMC-801,UMICH-FDU000505
Study Start Date: January 1994
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004339

Other Wilson Disease Studies:
1. Study of Zinc for Wilson Disease

2. Study of Tetrathiomolybdate in Patients With Wilson Disease

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