Status:
COMPLETED
Citocoline for Treatment in Fragile X-associated Tremor/Ataxia Syndrome
Lead Sponsor:
Rush University Medical Center
Conditions:
Fragile X Tremor/Ataxia Syndrome
Eligibility:
All Genders
18-90 years
Phase:
PHASE2
Brief Summary
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 st...
Detailed Description
The purpose of this study was to determine if citicoline was safe for the treatment of tremor and balance abnormalities and to stabilize cognitive decline in patients with fragile X-associated tremor ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2017
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT02197104
Start Date
January 1 2015
End Date
January 1 2017
Last Update
November 2 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Rush University Medical Center
Chicago, Illinois, United States, 60612