Study of Tetrathiomolybdate in Patients With Wilson Disease - Full Text View

Sponsor:	National Center for Research Resources (NCRR)
Collaborator:	University of Michigan
Information provided by:	National Center for Research Resources (NCRR)
ClinicalTrials.gov Identifier:	NCT00004339

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.

Condition	Intervention	Phase
Wilson Disease	Drug: tetrathiomolybdate Drug: trientine	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Masking: Double-Blind Primary Purpose: Treatment

Resource links provided by NLM:

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia succinic semialdehyde dehydrogenase deficiency Wilson disease

MedlinePlus related topics: Wilson Disease

Drug Information available for: Tetrathiomolybdate Trientine hydrochloride Triethylenetetramine

U.S. FDA Resources

Further study details as provided by National Center for Research Resources (NCRR):

Estimated Enrollment:	90
Study Start Date:	January 1994

Detailed Description:

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

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004339

Locations

United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109

Sponsors and Collaborators

National Center for Research Resources (NCRR)

University of Michigan

Investigators

Study Chair:

George J. Brewer

University of Michigan

More Information

Publications:

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.

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.

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.

ClinicalTrials.gov Identifier:	NCT00004339 History of Changes
Other Study ID Numbers:	NCRR-M01RR00042-1850, UMMC-801, UMICH-FDU000505
Study First Received:	October 18, 1999
Last Updated:	May 8, 2006
Health Authority:	United States: Federal Government

Keywords provided by National Center for Research Resources (NCRR):

Wilson disease
inborn errors of metabolism
rare disease

Additional relevant MeSH terms:

Hepatolenticular Degeneration
Liver Diseases
Digestive System Diseases
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Brain Diseases, Metabolic, Inborn
Brain Diseases, Metabolic
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Metabolism, Inborn Errors
Metal Metabolism, Inborn Errors

Metabolic Diseases
Trientine
Tetrathiomolybdate
Molybdenum
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012