The Safety and Efficacy of Cerebrolysin in Patients With Acute Ischemic Stroke

Summary

The study investigated the clinical efficacy and safety of a 10-day course of therapy with daily intravenous administration of 30mL Cerebrolysin based on a comparison with Placebo in patients with acute ischemic stroke. 1070 patients were randomized in this trial in 2 parallel groups, one receiving Cerebrolysin, the control group receiving Placebo. Study drug will be given once daily by intravenous infusion for 10 consecutive days. Acetylsalicylic acid will be given orally, once daily throughout the study duration of 90 days as basic treatment. The clinical observation period for each patient will be 3 months and will include six clinical evaluation visits at Baseline (day 1) and on study days 2, 5, 10, 30 and 90.

Timeline

Start

2006-09

Primary completion

2010-10

Completion

2011-02

Publications

• Background Hong Z, Moessler H, Bornstein N, Brainin M, Heiss WD; CASTA-Investigators. A double-blind, placebo-controlled, randomized trial to evaluate the safety and efficacy of Cerebrolysin in patients with acute ischaemic stroke in Asia--CASTA. Int J Stroke. 2009 Oct;4(5):406-12. doi: 10.1111/j.1747-4949.2009.00340.x.
• Results Heiss WD, Brainin M, Bornstein NM, Tuomilehto J, Hong Z; Cerebrolysin Acute Stroke Treatment in Asia (CASTA) Investigators. Cerebrolysin in patients with acute ischemic stroke in Asia: results of a double-blind, placebo-controlled randomized trial. Stroke. 2012 Mar;43(3):630-6. doi: 10.1161/STROKEAHA.111.628537. Epub 2012 Jan 26.
• Results Bornstein NM, Guekht A, Vester J, Heiss WD, Gusev E, Homberg V, Rahlfs VW, Bajenaru O, Popescu BO, Muresanu D. Safety and efficacy of Cerebrolysin in early post-stroke recovery: a meta-analysis of nine randomized clinical trials. Neurol Sci. 2018 Apr;39(4):629-640. doi: 10.1007/s10072-017-3214-0. Epub 2017 Dec 16.

Drugs

Indications