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The objective of this study is to determine if citocoline is effective for balance abnormalities and to stabilize cognitive decline in patients with fragile X-associated tremor ataxia syndrome. The study will test 1000mg twice daily of citocoline for 12 months in an open label pilot study, with study visits at baseline, 3, 6, and 12 months.
Condition or disease
Balance and Cognitive Deficits in Fragile X-associated Tremor Ataxia Syndrome
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Ages Eligible for Study:
18 Years to 90 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Clinical diagnosis of FXTAS
Serum creatine kinase, complete metabolic panel, complete blood count, liver function tests, renal function tests, platelets and EKG are within normal limits
Legal incapacity or limited legal capacity
Presence of severe renal disease (BUN 50% greater than normal or creatinine clearance <60 mL/min) or hepatic disease.
Abnormal creatine kinase and/or platelet count in the past 6 months (as determined by lab reports obtained from primary care physicians or conducted at baseline).
Women of childbearing potential who are pregnant at the time of screening or who will not use adequate protection during participation of the study.
Allergy/sensitivity to the drug of its formulations.
Concurrent participation in another clinical study.
Active substance use or dependence.
Serious illness (requiring systematic treatment/or hospitalization) until the subject either completes therapy or is clinically stable on therapy, in the opinion of the site investigator, for at least 60 days prior to study entry.
Inability or unwillingness of the subject or legal guardian/representative to give written informed consent.