ICTUS Study: International Citicoline Trial on Acute Stroke

• Status: Terminated
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ferrer Internacional S.A.
• Treatments: Choline; Cytidine Diphosphate Choline

Criteria

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 confound the interpretation of the neurological scales

• Drug addiction-related disorders

• Pre existing dementia, when dementia implies a disability, measured as an score of 2 or higher in the previous MRS

• Pre existing medical condition that, in the Investigator's opinion, may interfere with the patient's suitability and participation in the study

• Patients participating in another clinical trial or receiving a non-approved drug (clinical investigational drug) less than 30 days prior to screening

• Patients under current treatment with citicoline