Research: Clinical Trials
Phase III Study of Tetrathiomolybdate Dose Regimen in Neurological Wilson's Disease
INVESTIGATORS: Dr. Brewer
SPONSOR: Juvenile Diabetes Research Foundation
Patients to be recruited to this study will be adults and children (if they and a parent or guardian are capable of informed consent) with Wilson's disease, presenting with neurological symptoms (not solely psychiatric or hepatic), capable of informed consent and of complying with the prescribed regimen. Patients who have not been treated for longer than four weeks with penicillamine or trientine immediately prior to enrollment in the study are eligible. Patients coming to Michigan will be housed in the Clinical Research Center (GCRC) of the University of Michigan Hospital, or maintained in the Ann Arbor area, for up to about 6 weeks.
Individuals may be excluded from participation if they have concurrent seizure activity, such that the seizures are not under consistent control with medication, or concurrent liver failure. Pregnant women and nursing mothers are also excluded. A pregnancy screening test will be done at the time of enrollment at no cost to the women. Additional medical conditions that may make it difficult to comply with the program, or make it difficult for the researchers to evaluate the Wilson's disease therapy, will also be reasons for exclusion.
Principal Investigator: George J Brewer, MD
Study Coordinator: Julia Sitterly
Campus Address: 5022 Kresge Bldg II SPC 5534