Study of Tetrathiomolybdate in Patients With Wilson Disease
NCT ID: NCT00004339
Last Updated: 2006-05-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
90 participants
INTERVENTIONAL
1994-01-31
Brief Summary
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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 Description
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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.
Conditions
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Study Design
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RANDOMIZED
TREATMENT
DOUBLE
Interventions
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tetrathiomolybdate
trientine
Eligibility Criteria
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Inclusion 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
0 Years
ALL
No
Sponsors
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University of Michigan
OTHER
National Center for Research Resources (NCRR)
NIH
Principal Investigators
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George J. Brewer
Role: STUDY_CHAIR
University of Michigan
Locations
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University of Michigan
Ann Arbor, Michigan, United States
Countries
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References
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Brewer GJ, Dick RD, Johnson V, Wang Y, Yuzbasiyan-Gurkan V, Kluin K, Fink JK, Aisen A. Treatment of Wilson's disease with ammonium tetrathiomolybdate. I. Initial therapy in 17 neurologically affected patients. Arch Neurol. 1994 Jun;51(6):545-54. doi: 10.1001/archneur.1994.00540180023009.
Brewer GJ, Johnson V, Dick RD, Kluin KJ, Fink JK, Brunberg JA. Treatment of Wilson disease with ammonium tetrathiomolybdate. II. Initial therapy in 33 neurologically affected patients and follow-up with zinc therapy. Arch Neurol. 1996 Oct;53(10):1017-25. doi: 10.1001/archneur.1996.00550100103019.
Brewer GJ, Askari F, Lorincz MT, Carlson M, Schilsky M, Kluin KJ, Hedera P, Moretti P, Fink JK, Tankanow R, Dick RB, Sitterly J. Treatment of Wilson disease with ammonium tetrathiomolybdate: IV. Comparison of tetrathiomolybdate and trientine in a double-blind study of treatment of the neurologic presentation of Wilson disease. Arch Neurol. 2006 Apr;63(4):521-7. doi: 10.1001/archneur.63.4.521.
Other Identifiers
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UMMC-801
Identifier Type: -
Identifier Source: secondary_id
UMICH-FDU000505
Identifier Type: -
Identifier Source: secondary_id
NCRR-M01RR00042-1850
Identifier Type: -
Identifier Source: org_study_id