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

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. Identifier: NCT00331890
Recruitment Status : Terminated (With 2078 patients, a statistical stopping boundary has now been crossed)
First Posted : May 31, 2006
Last Update Posted : June 20, 2012
Information provided by (Responsible Party):
Ferrer Internacional S.A.

Brief 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

Condition or disease Intervention/treatment Phase
Acute Stroke Cerebral Infarction Drug: Citicoline Drug: Placebo Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2298 participants
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
Study Start Date : October 2006
Actual Primary Completion Date : February 2012
Actual Study Completion Date : March 2012

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. mRS at 3 months [ Time Frame: 3 months ]
  2. Barthel Index at 3 months [ Time Frame: 3 months ]
  3. Safety and tolerability [ Time Frame: 3 months ]

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, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT00331890

  Hide Study Locations
Klinikum AltenburgerLand GmbH
Altenburg, Germany, 4600
Neurologie EVKB
Bielefeld, Germany, 33617
Neurologische Klinik Heinrich-Heine Universität
Dusseldorf, Germany, 40225
Universitätsklinikum Erlangen
Erlangen, Germany, 91054
Ernst-Moritz-Arndt-Universität Greifswald
Greifswald, Germany, 17489
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany, 20246
Neurologische Klinik Universitatsklinikum Heidelberg
Heidelberg, Germany, 69120
Klinikum Ingolstadt
Ingolstadt, Germany, 85049
Universitätsklinikum Leipzig
Leipzig, Germany, 04103
Johannes Wesling Klinikum Minden
Minden, Germany, 32429
Klinikum Großhadern der Universität München
München, Germany, 81377
Universitätsklinikum Münster
Münster, Germany, 48149
Hospital Garcia de Orta, EPE
Almada, Portugal, 2801-951
Hospital Garcia de Orta
Almada, Portugal
Hospital Fernando Fonseca
Amadora - Sintra, Portugal, 2720-276
Hospital Sao Marcos
Braga, Portugal, 4700-308
Hospitais da Universidade Coimbra
Coimbra, Portugal, 3000-075
Centro Hospitalar de Coimbra
Coimbra, Portugal, 3040-324
Hospital de Sao Jose
Lisbon, Portugal, 1150-119
Hospital de Santa Maria
Lisbon, Portugal, 1649-028
Hospital de Santo Antonio
Porto, Portugal, 4099-001
Hospital de Sao Joao
Porto, Portugal, 4202-451
Hospital Sao Sebastiao
Santa Maria da Feira, Portugal, 4520-211
Centro Hospitalar de Setúbal
Setubal, Portugal
Centro Hospitalar de Setúbal, EPE
Setúbal, Portugal, 2910-446
Hospital Sao Pedro
Vila Real, Portugal, 5000-508
Hospital Son Dureta
Palma de Mallorca, Baleares, Spain, 07014
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
Hospital Universitario de Bellvitge
Hospitalet de Llobregat, Barcelona, Spain, 08907
Hospital de Mataro
Mataro, Barcelona, Spain, 08304
Consorci Hospitalari Parc Tauli
Sabadell, Barcelona, Spain, 08208
Hospital Moises Broggi
Sant Joan Despi, Barcelona, Spain, 08970
Hospital Clinico Universitario de Santiago
Santiago de Compostela, La Coruña, Spain, 15706
Hospital de Navarra
Pamplona, Navarra, Spain, 31060
Hospital Meixoeiro
Vigo, Pontevedra, Spain, 36200
Hospital de Cruces
Barakaldo, Vizcaya, Spain, 48903
Hospital de Basurto
Bilbao, Vizcaya, Spain, 48013
Hospital General de Albacete
Albacete, Spain, 02006
Hospital del Mar
Barcelona, Spain, 08003
Hospital de la Santa Creu I Sant Pau
Barcelona, Spain, 08025
Hospital Sagrat Cor
Barcelona, Spain, 08029
Hospital Vall d´Hebron
Barcelona, Spain, 08035
Hospital General Yague
Burgos, Spain, 09005
Hospital San Pedro de Alcantara
Caceres, Spain, 10003
Hospital de Girona Dr. Josep Trueta
Girona, Spain, 17007
Hospital de Leon
Leon, Spain, 24071
Hospital Universitari Arnau de Vilanova
Lleida, Spain, 25198
Hospital Arnau de Vilanova
Lleida, Spain
Complejo Hospitalario Xeral Calde
Lugo, Spain, 27004
Hospital de La Princesa
Madrid, Spain, 28006
Hospital Universitario Gregorio Marañon
Madrid, Spain, 28007
Hospital Ramon y Cajal
Madrid, Spain, 28034
Hospital Clinico San Carlos
Madrid, Spain, 28040
Hospital Universitario La Paz
Madrid, Spain, 28046
Hospital Central de Defensa (del Aire)
Madrid, Spain, 28047
Hospital Marqués de Valdecilla
Santander, Spain, 39008
Hospital Marqués de Valdecilla
Santander, Spain
Hospital Virgen Macarena
Sevilla, Spain, 41009
Hospital Universitario Virgen del Rocio
Sevilla, Spain, 41013
Hospital Universitario Nuestra Señora De Valme
Sevilla, Spain, 41014
Hospital Universitario La Fe
Valencia, Spain, 46009
Hospital Clinico Universitario
Valencia, Spain, 46010
Hospital General Universitario de Valencia
Valencia, Spain, 46014
Hospital Clínico de Valladolid
Valladolid, Spain, 47005
Hospital Universitario
Valladolid, Spain
Sponsors and Collaborators
Ferrer Internacional S.A.
Study Chair: Antoni Dávalos, MD, PhD Hospital Universitari Germans Trias i Pujol, Badalona (Spain)

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

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

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