ICTUS Study: International Citicoline Trial on Acute Stroke - Full Text View

Sponsor:	Ferrer Internacional S.A.
Information provided by (Responsible Party):	Ferrer Internacional S.A.
ClinicalTrials.gov Identifier:	NCT00331890

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 III

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:

Drug Information available for: Choline Choline chloride Choline dihydrogen citrate Choline bitartrate Cytidine diphosphate choline Choline salicylate

U.S. FDA Resources

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 ]

Estimated Enrollment:	2300
Study Start Date:	October 2006
Estimated Study Completion Date:	April 2012
Estimated 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

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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

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:

Register of ischemic stroke trials This link exits the ClinicalTrials.gov site

Register of stroke trials This link exits the ClinicalTrials.gov site

Protocol reviewed by The Lancet This link exits the ClinicalTrials.gov site

Publications:

Bolland K, Whitehead J, Cobo E, Secades JJ. Evaluation of a sequential global test of improved recovery following stroke as applied to the ICTUS trial of citicoline. Pharm Stat. 2008 Jul 21; [Epub ahead of print]

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:	October 28, 2011
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 February 09, 2012