Study of Tetrathiomolybdate in Patients With Wilson Disease

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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