NCT02197104 is a Phase 2 clinical trial of citocoline in Fragile X Tremor/Ataxia Syndrome, sponsored by Rush University Medical Center.

Who is sponsoring NCT02197104?

NCT02197104 is sponsored by Rush University Medical Center.

What drugs are being tested in NCT02197104?

Interventions in NCT02197104: citocoline.

What condition does NCT02197104 study?

NCT02197104 studies Fragile X Tremor/Ataxia Syndrome.

Is NCT02197104 still recruiting?

NCT02197104 is currently completed. Last updated 1 November 2022.

Are results published for NCT02197104?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2022-11-01 · How we verify

NCT02197104

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 2 Results posted Last updated 1 November 2022

What this trial tests

Phase 2 trial testing citocoline in Fragile X Tremor/Ataxia Syndrome in 10 participants. Completed in 1 January 2017.

Timeline

1 January 2015

Primary endpoint
1 January 2017

1 January 2017

Quick facts

Lead sponsor	Rush University Medical Center
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	10
Start date	1 January 2015
Primary completion	1 January 2017
Estimated completion	1 January 2017
Sites	1 location across United States

Drugs / interventions tested

citocoline — full drug profile →

Conditions studied

Fragile X Tremor/Ataxia Syndrome — all drugs for Fragile X Tremor/Ataxia Syndrome →

Sponsor

Rush University Medical Center

Who can join

Adults 18 to 90, any sex, with Fragile X Tremor/Ataxia Syndrome. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

FXTAS Rating Scale Score
Time frame: 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 Coopera

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Fragile X-Associated Tremor/Ataxia Syndrome: Unmet Needs and a Path for the Future.
Hall DA, Hagerman RJ. · · 2018 · cited 3× · PMID 29951081 · DOI 10.3389/fgene.2018.00100

Verify or expand the search:

Other Rush University Medical Center trials

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02197104 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Rush University Medical Center
Last refreshed: 1 November 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02197104.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing