TerminatedPhase 3

ICTUS Study: International Citicoline Trial on Acute Stroke

Stopped: With 2078 patients, a statistical stopping boundary has now been crossed

Germany, Portugal, Spain2,298 participantsStarted 2006-10

Plain-language summary

Citicoline is a safe drug approved in some countries for the treatment of acute ischemic stroke. The drug has shown some evidence of efficacy in a pooled analysis, based on four clinical trials done in USA with oral citicoline.The purpose of the study is confirm the results obtained in the pooled analysis, that is, evidence of efficacy in the treatment of acute ischemic stroke

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Male or female, \>18 years old * Patients must be treated within 24 hours of their initial stroke symptoms onset. * Patients with a measurable focal neurological deficit lasting for a minimum of 60 minutes. * Patients must have a CT scan and/or conventional MRI compatible with the clinical diagnosis of acute ischemic stroke prior to being randomized. * Patients must have an acute ischemic stroke referable to the middle cerebral artery territory * At inclusion, NIHSS score \> 7, with at least 2 of these points from sections 5 \& 6 (motor) * Immediately (i.e. minutes) pre-stroke, MRS \< 2 * Women of childbearing potential must have a negative pregnancy test prior to enrolment * Signed informed consent Exclusion Criteria: * Patients in coma: patients having a score of 2 or higher in the items regarding the level of consciousness in the NIHSS (1a) * CT or conventional MRI evidence of brain tumor, cerebral edema with a clinically significant mass midline shift with compression of the ventricles, brainstem or cerebellar infarction, subarachnoid and/or intracerebral and/or intraventricular hemorrhage * History of ventricular dysrhythmias, acute myocardial infarction within 72 hours prior to enrolment, unstable angina, decompensated congestive heart failure or any other acute, severe, uncontrollable or sustained cardiovascular condition that, in the Investigator's opinion, may interfere with effective participation in the study * Previous disorders that may c…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Total recovery at three months of onset, based on a global test analysis including NIHSS, mRS and Barthel Index

Timeframe: 3 months

Trial details

NCT IDNCT00331890

SponsorFerrer Internacional S.A.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-02

View on ClinicalTrials.gov More Acute Stroke trials