ICTUS Study: International Citicoline Trial on Acute Stroke

This study has been terminated.
(With 2078 patients, a statistical stopping boundary has now been crossed)
Sponsor:
Information provided by (Responsible Party):
Ferrer Internacional S.A.
ClinicalTrials.gov Identifier:
NCT00331890
First received: May 30, 2006
Last updated: June 19, 2012
Last verified: June 2012
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Citicoline in the Treatment of Acute Ischemic Stroke. An International Randomized Multicenter Placebo-controlled Study

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • mRS at 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Barthel Index at 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Safety and tolerability [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: May 30, 2006
Last Updated: June 19, 2012
Health Authority: Spain: Spanish Agency of Medicines
Portugal: National Pharmacy and Medicines Institute
Germany: Federal Institute for Drugs and Medical Devices

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

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

ClinicalTrials.gov processed this record on July 24, 2014