drugset / Trial / NCT00331890
ICTUS Study: International Citicoline Trial on Acute Stroke
RandomizedParallel-groupQuadruple-blindTreatment
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
Timeline
- Start
- 2006-10
- Primary completion
- 2012-02
- Completion
- 2012-03
Outcome
Missed primary endpoint
Stopped: “With 2078 patients, a statistical stopping boundary has now been crossed”
paper Global recovery was similar in both groups (odds ratio 1·03, 95% CI 0·86-1·25; p=0·364). PMID 22691567 ↗
Publications
- Background 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. 2009 Apr-Jun;8(2):136-49. doi: 10.1002/pst.344.
- Results Davalos A, Alvarez-Sabin J, Castillo J, Diez-Tejedor E, Ferro J, Martinez-Vila E, Serena J, Segura T, Cruz VT, Masjuan J, Cobo E, Secades JJ; International Citicoline Trial on acUte Stroke (ICTUS) trial investigators. Citicoline in the treatment of acute ischaemic stroke: an international, randomised, multicentre, placebo-controlled study (ICTUS trial). Lancet. 2012 Jul 28;380(9839):349-57. doi: 10.1016/S0140-6736(12)60813-7. Epub 2012 Jun 11.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Citicoline | Other / unclassified | 1 g | Intravenous |