Combined Treatment With Alteplase (Rt-PA) and Cerebrolysin® in Acute Ischemic Hemispheric Stroke

Phase 3 Completed 119 enrolled Ever Neuro Pharma GmbH JSW-Research Forschungslabor GmbH, Parkring 12, 8074 Grambach · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

It should be shown that Cerebrolysin in combination with Alteplase, the medication that should recover the blood flow through the brain, is an effective and save medication to treat ischeamic stroke.

Timeline

Start: 2005-10
Primary completion: 2008-03
Completion: 2008-07

Outcome

Missed primary endpoint

paper The third interim analysis did not show a benefit in the modified Rankin Scale for Cerebrolysin on day 90 compared to placebo PMID 23009193 ↗

paper but did not improve outcome at day 90 PMID 23009193 ↗

Publications

Lang W, Stadler CH, Poljakovic Z, Fleet D; Lyse Study Group. A prospective, randomized, placebo-controlled, double-blind trial about safety and efficacy of combined treatment with alteplase (rt-PA) and Cerebrolysin in acute ischaemic hemispheric stroke. Int J Stroke. 2013 Feb;8(2):95-104. doi: 10.1111/j.1747-4949.2012.00901.x. Epub 2012 Sep 26.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cerebrolysin	Peptide	30 ml	Intravenous