Trial · NCT02197104
Citocoline for Treatment in Fragile X-associated Tremor/Ataxia Syndrome
NCT02197104, Phase 2, Completed, Rush University Medical Center; results first posted 2022-11-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Citocoline for Treatment in Fragile X-associated Tremor/Ataxia Syndrome. Trials, record NCT02197104. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02197104
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Citocoline for Treatment in Fragile X-associated Tremor/Ataxia Syndrome
- NCT number
- NCT02197104
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 10 participants, actual
- Lead sponsor
- Rush University Medical Center
- Conditions
- Fragile X Tremor/Ataxia Syndrome
- Interventions
- citocoline
- First posted
- 2014-07-22
- Last updated
- 2022-11-02
- Results first posted
- 2022-11-02
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | FXTAS Rating Scale Score | 12 months | 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 resultant scale has 44 items and a possible total score of 0-226. A higher score indicates worse symptoms. For this study, improvement was defined as a 20% improvement on the FXTAS-RS. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | FXTAS Rating Scale Score | 12 months | 9 patients with FXTAS who participated in the study for 12 months were analyzed. | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group1
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| FXTAS Rating Scale Score | Citocoline | 45.8 | Standard Deviation 21.22 | score on a scale |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Citocoline | 10 | |
| Overall Study | COMPLETED | Citocoline | 9 | |
| Overall Study | NOT COMPLETED | Citocoline | 1 |
Source ClinicalTrials.gov
Adverse events7
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Bruising | Blood and lymphatic system disorders | Citocoline | 1 | 10 | 1 |
| other | Dizziness | Nervous system disorders | Citocoline | 2 | 10 | 2 |
| other | Leg edema | Blood and lymphatic system disorders | Citocoline | 1 | 10 | 1 |
| other | Weight gain | General disorders | Citocoline | 1 | 10 | 1 |
| serious | Gastrointestinal disorders | Gastrointestinal disorders | Citocoline | 2 | 10 | 2 |
| serious | Falls | Nervous system disorders | Citocoline | 3 | 10 | 3 |
| serious | Low platelet count | Immune system disorders | Citocoline | 1 | 10 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Citocoline | 0 | 10 |
| Total, other adverse events | Citocoline | 5 | 10 |
| Total, serious adverse events | Citocoline | 6 | 10 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32053612 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02197104
GET https://conductscience.org/api/trials/v1/NCT02197104/registered