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Sponsors and Collaborators: |
National Center for Research Resources (NCRR) University of Michigan |
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Information provided by: | National Center for Research Resources (NCRR) |
ClinicalTrials.gov Identifier: | NCT00004339 |
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.
Condition | Intervention | Phase |
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Wilson Disease |
Drug: tetrathiomolybdate Drug: trientine |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind |
Estimated Enrollment: | 90 |
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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
--Prior/Concurrent Therapy--
--Patient Characteristics--
Study ID Numbers: | NCRR-M01RR00042-1850, UMMC-801, UMICH-FDU000505 |
Study First Received: | October 18, 1999 |
Last Updated: | May 8, 2006 |
ClinicalTrials.gov Identifier: | NCT00004339 History of Changes |
Health Authority: | United States: Federal Government |
Wilson disease inborn errors of metabolism rare disease |
Liver Diseases Hepatolenticular Degeneration Basal Ganglia Diseases Brain Diseases Neurodegenerative Diseases Tetrathiomolybdate Metabolism, Inborn Errors Heredodegenerative Disorders, Nervous System Movement Disorders Wilson Disease Brain Diseases, Metabolic, Inborn Micronutrients Triethylenetetramine |
Metabolic Disorder Ganglion Cysts Metabolic Diseases Molybdenum Rare Diseases Central Nervous System Diseases Trace Elements Angiogenesis Inhibitors Digestive System Diseases Genetic Diseases, Inborn Chelating Agents Brain Diseases, Metabolic |
Liver Diseases Hepatolenticular Degeneration Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Basal Ganglia Diseases Neurodegenerative Diseases Brain Diseases Tetrathiomolybdate Metabolism, Inborn Errors Heredodegenerative Disorders, Nervous System Movement Disorders Therapeutic Uses Micronutrients Growth Inhibitors |
Brain Diseases, Metabolic, Inborn Angiogenesis Modulating Agents Triethylenetetramine Metabolic Diseases Growth Substances Nervous System Diseases Molybdenum Central Nervous System Diseases Trace Elements Enzyme Inhibitors Metal Metabolism, Inborn Errors Angiogenesis Inhibitors Pharmacologic Actions Digestive System Diseases Genetic Diseases, Inborn |