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ICTUS Study: International Citicoline Trial on Acute Stroke (ICTUS)

This study has been terminated.
(With 2078 patients, a statistical stopping boundary has now been crossed)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00331890
First Posted: May 31, 2006
Last Update Posted: June 20, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ferrer Internacional S.A.
  Purpose
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

Condition Intervention Phase
Acute Stroke Cerebral Infarction Drug: Citicoline Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Citicoline in the Treatment of Acute Ischemic Stroke. An International Randomized Multicenter Placebo-controlled Study

Further study details as provided by Ferrer Internacional S.A.:

Primary Outcome Measures:
  • Total recovery at three months of onset, based on a global test analysis including NIHSS, mRS and Barthel Index [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • mRS at 3 months [ Time Frame: 3 months ]
  • Barthel Index at 3 months [ Time Frame: 3 months ]
  • Safety and tolerability [ Time Frame: 3 months ]

Enrollment: 2298
Study Start Date: October 2006
Study Completion Date: March 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active
Receives active drug
Drug: Citicoline
1g/12h iv during 3 days and then orally until complete 6 weeks of treatment
Other Name: CDP-choline
Placebo Comparator: Placebo
Receives a placebo
Drug: Placebo
As active drug

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00331890


  Show 65 Study Locations
Sponsors and Collaborators
Ferrer Internacional S.A.
Investigators
Study Chair: Antoni Dávalos, MD, PhD Hospital Universitari Germans Trias i Pujol, Badalona (Spain)
  More Information

Additional Information:
Publications:
Responsible Party: Ferrer Internacional S.A.
ClinicalTrials.gov Identifier: NCT00331890     History of Changes
Other Study ID Numbers: GF-ICTUS-04
First Submitted: May 30, 2006
First Posted: May 31, 2006
Last Update Posted: June 20, 2012
Last Verified: June 2012

Keywords provided by Ferrer Internacional S.A.:
Neuroprotection
Acute ischemic stroke
Cerebral infarction

Additional relevant MeSH terms:
Stroke
Infarction
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Ischemia
Pathologic Processes
Necrosis
Brain Infarction
Brain Ischemia
Cytidine Diphosphate Choline
Nootropic Agents