CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 10 enrolled
Drug / intervention
citocolinedrug
Likely dose
citocoline 1,000mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02197104
NCT02197104Phase 2Completed
CompareCT.gov

Phase 2 Study of Citocoline for Treatment in Fragile X-associated Tremor/Ataxia Syndrome

Rush University Medical Center·interventional·Posted Jul 22, 2014·Updated Nov 2, 2022

In Brief

A Phase 2 clinical trial evaluating citocoline for Fragile X Tremor/Ataxia Syndrome. Completed, enrolled 10 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFragile X Tremor/Ataxia Syndrome
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJul 22, 2014
Enrollment StartJan 1, 2015
Primary CompletionJan 1, 2017
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 11.9 years ago

Interventions

citocolinedrug

Ten subjects will receive 1,000mg once daily of citicoline. Each subject will stay on the study drug for 12 months. The outcome measures will be assessed at baseline and then again at the end of month 3, month 6, and month 12. The subjects will continue taking the same study drug at the same dose throughout the entire trial.