Completed

Tetrathiomolybdate vs Trientine Therapy in Wilson Disease

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What is being tested

tetrathiomolybdate

+ trientine

Drug
Who is being recruted

Basal Ganglia Diseases+19

+ Brain Diseases

+ Brain Diseases, Metabolic

See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: January 1994
See protocol details

Summary

Principal SponsorNational Center for Research Resources (NCRR)
Last updated: May 9, 2006
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 1994

Actual date on which the first participant was enrolled.

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.

NCT00004339
Principal SponsorNational Center for Research Resources (NCRR)
Last updated: May 9, 2006
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

90 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Basal Ganglia DiseasesBrain DiseasesBrain Diseases, MetabolicCentral Nervous System DiseasesDigestive System DiseasesLiver DiseasesMetabolic DiseasesMetal Metabolism, Inborn ErrorsMovement DisordersCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNervous System DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsNeurodegenerative DiseasesHeredodegenerative Disorders, Nervous SystemBrain Diseases, Metabolic, InbornDisease AttributesGenetic Diseases, InbornHepatolenticular DegenerationMetabolism, Inborn ErrorsRare Diseases

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

University of Michigan

Ann Arbor, United StatesOpen University of Michigan in Google Maps
CompletedOne Study Center