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:
Ferrer Internacional S.A.
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
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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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00331890
Show 65 Study Locations
Show 65 Study LocationsSponsors 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 May 19, 2013