Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University of South Florida
With
Baxter Healthcare Corporation
Age
10–50
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Outpatients with SCA diagnosed by a movement disorder specialist.
2. Age 10 years to 80 years.
3. Able to ambulate with or without assistance for 30 feet.
4. Women of child-bearing potential must use a reliable method of contraception and must provide a negative pregnancy test at entry into the study.
5. Serum creatine kinase, complete metabolic panel, complete blood count, liver function tests, renal function tests, platelets and EKG do not reveal clinically significant abnormalities (results obtained from primary care physician and dated within the past 6 months or obtained at screening visit).
6. Stable doses of all medications for 30 days prior to study entry and for the duration of the study.
7. Stable doses of all antidepressants and vitamins (including internet purchased idebenone) for 30 days prior to study entry and for the duration of the study. Throughout the study, all possible efforts should be made to maintain stable doses of all other medications.
8. Subject permission (informed consent).
4. Presence of diabetes (as determined by blood glucose labs within the past 6 months).
5. Dementia or other psychiatric illness that prevents the subject from giving informed consent (MMSE less than 25).
6. Legal incapacity or limited legal capacity.
7. Presence of severe renal disease (estimated creatinine clearance \<50 mL/min) or hepatic disease (AST or ALT\>2x times normal) (as evidenced by labs reported within the past 6 months).
8. Clinically significantly abnormal WBC, hemoglobin or platelet count (as evidenced by labs reported within the past 6 months).
9. IgA deficiency (evidenced by screening lab evaluations)
You may not be if
1. Any unstable illness that in the investigator's opinion precludes participation in this study.
2. Use of any investigational product within the past 30 days.
