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NCT02197104 · ClinicalTrials.gov registry record · Phase 2
Citocoline for Treatment in Fragile X-associated Tremor/Ataxia Syndrome
A Phase 2 study, sponsored by Rush University Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
NCT02197104: Completed Phase 2 study, sponsored by Rush University Medical Center.
NCT02197104 is a Phase 2 study that has completed, run by Rush University Medical Center. The registered enrollment target is 10 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02197104, a Phase 2 study, has completed, sponsored by Rush University Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
Study 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.
Primary Outcome
The FXTAS Rating Scale (FXTAS-RS), which was designed to measure the severity of motor signs in FXTAS patients, was administered to each participant. The FXTAS-RS was designed to measure the severity of motor signs of FXTAS, tremor, ataxia, and parkinsonism. The scale was developed from a combination of three separate measures: the Clinical Rating Scale for Tremor (CRST), the International Cooperative Ataxia Rating Scale (ICARS), and the Unified Parkinson's Disease Rating Scale (UPDRS). The resu
Interventions
- DRUG citocoline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2015-01 |
| Est. Completion | 2017-01 |
| Phase | Phase 2 |
What the finished NCT02197104 record still lists
NCT02197104 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 1 intervention - of which citocoline is the first listed.
NCT02197104 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02197104 about?
NCT02197104 is a clinical study titled "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 stud...
What is the current status of trial NCT02197104?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2015-01. Estimated completion is 2017-01.
What interventions are being tested in trial NCT02197104?
The interventions under investigation include: citocoline (DRUG).
Who is sponsoring clinical trial NCT02197104?
This trial is sponsored by Rush University Medical Center, which has 320 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02197104's enrollment target sits among peer trials
10 1968th of 2000 higher than 12 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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