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Study of Tetrathiomolybdate in Patients With Wilson Disease

Primary Purpose

Wilson Disease

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

tetrathiomolybdate

trientine

About this trial

This is an interventional treatment trial for Wilson Disease focused on measuring Wilson disease, inborn errors of metabolism, rare disease

Eligibility Criteria

0 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Michigan

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00004339

First Posted

October 18, 1999

Last Updated

May 8, 2006

Sponsor

National Center for Research Resources (NCRR)

Collaborators

University of Michigan

1. Study Identification

Unique Protocol Identification Number

NCT00004339

Brief Title

Study of Tetrathiomolybdate in Patients With Wilson Disease

Study Type

Interventional

2. Study Status

Record Verification Date

December 2003

Overall Recruitment Status

Completed

Study Start Date

January 1994 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

National Center for Research Resources (NCRR)

Collaborators

University of Michigan

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Wilson Disease

Keywords

Wilson disease, inborn errors of metabolism, rare disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Masking

Double

Allocation

Randomized

Enrollment

90 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

tetrathiomolybdate

Intervention Type

Drug

Intervention Name(s)

trientine

10. Eligibility

Sex

All

Minimum Age & Unit of Time

0 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

George J. Brewer

Organizational Affiliation

University of Michigan

Official's Role

Study Chair

Facility Information:

Facility Name

University of Michigan

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

8198464

Citation

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. doi: 10.1001/archneur.1994.00540180023009.

Results Reference

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PubMed Identifier

8859064

Citation

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. doi: 10.1001/archneur.1996.00550100103019.

Results Reference

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PubMed Identifier

16606763

Citation

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. doi: 10.1001/archneur.63.4.521.

Results Reference

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Study of Tetrathiomolybdate in Patients With Wilson Disease

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