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Citocoline for Treatment of FXTAS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02197104
Recruitment Status : Completed
First Posted : July 22, 2014
Last Update Posted : August 30, 2017
Information provided by (Responsible Party):
Deborah Hall, MD, Rush University Medical Center

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 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 Intervention/treatment Phase
Balance and Cognitive Deficits in Fragile X-associated Tremor Ataxia Syndrome Drug: citocoline Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 2 Study of Citocoline for Treatment in Fragile X-associated Tremor/Ataxia Syndrome
Study Start Date : January 2015
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017

Arm Intervention/treatment
Experimental: Citocoline Drug: citocoline

Primary Outcome Measures :
  1. FXTAS Rating Scale Score [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02197104

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United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Rush University Medical Center
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Deborah Hall, MD, Associate Professor Neurological Sciences, Rush University Medical Center Identifier: NCT02197104    
Other Study ID Numbers: CITO-123
First Posted: July 22, 2014    Key Record Dates
Last Update Posted: August 30, 2017
Last Verified: August 2017
Additional relevant MeSH terms:
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Cognition Disorders
Cognitive Dysfunction
Pathologic Processes
Neurologic Manifestations
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders