Tetrathiomolybdate vs Trientine Therapy in Wilson Disease
Data Collection
Basal Ganglia Diseases+19
+ Brain Diseases
+ Brain Diseases, Metabolic
Treatment Study
Summary
Study start date: January 1, 1994
Actual date on which the first participant was enrolled.This study focuses on treating patients with Wilson Disease, a condition where excess copper accumulates in the body. The main goal is to compare the effectiveness of two different treatments: tetrathiomolybdate (TM) and trientine. The study is important because it could help improve the care for patients with Wilson Disease by identifying which treatment works better and is safer. The study is designed for patients with this condition. In this double-blind, randomized study, patients are assigned to one of two treatment arms. In the first arm, patients receive TM three times a day with meals and three times a day between meals for 8 weeks. In the second arm, patients receive trientine therapy for 8 weeks. Patients in the TM group may also receive maintenance zinc, while those in the trientine group may continue on trientine or switch to zinc. The study measures the results by evaluating the patients' response to these treatments over the 8-week period.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.90 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
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