Brief Title
Study of Tetrathiomolybdate in Patients With Wilson Disease
Brief Summary
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.
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.
Study Phase
Phase 3
Study Type
Interventional
Condition
Wilson Disease
Intervention
tetrathiomolybdate
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
90
Start Date
January 1994
Eligibility 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
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
George J. Brewer, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00004339
Organization ID
NCRR-M01RR00042-1850
Secondary IDs
UMMC-801
Study Sponsor
National Center for Research Resources (NCRR)
Collaborators
University of Michigan
Study Sponsor
George J. Brewer, Study Chair, University of Michigan
Verification Date
December 2003