Citocoline for Treatment of FXTAS
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Cognitive Studies, Neurology |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/2/2016 |
| Start Date: | September 2014 |
| Contact: | Deborah Hall, MD PhD |
| Email: | deborah_a_hall@rush.edu |
| Phone: | 312-563-2900 |
Phase 2 Study of Citocoline for Treatment in Fragile X-associated Tremor/Ataxia Syndrome
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.
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.
Inclusion Criteria:
- 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 Criteria:
- 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.
We found this trial at
1
site
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
Click here to add this to my saved trials
