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
Lang W, Stadler CH, Poljakovic Z, Fleet D, Lyse Study Group · 2013 · Int J Stroke 8:95-104
Reported findings and study design
The trial stopped after an interim analysis found no day-90 modified Rankin Scale benefit. Early neurological responder analyses favored Cerebrolysin at days 2, 5, 10 and 30.
Dose, route and schedule
Cerebrolysin 30 mL/day intravenously for 10 days versus placebo, starting one hour after alteplase; acute enrollment within three hours of symptom onset. Historical study methods, not personal-use instructions.
Protocol source ↗ · Indexed abstract
| Measure | Result | Comparison, timing and statistics |
|---|---|---|
| Day-90 modified Rankin Scale | No benefit; trial stopped at third interim analysis | |
| Early NIHSS responder analysis | Favored Cerebrolysin at days 2, 5, 10 and 30 | Secondary endpoint; response ≥6-point improvement or total score 0–1 |
| Adverse events | No between-group difference reported |
The primary disability endpoint was neutral; early secondary responder findings do not establish a day-90 benefit.
Source for the extracted data ↗ · Checked 2026-11-01
Molekul summary of the linked publication. Educational information, not medical advice. Seek qualified healthcare help for medical conditions.
Methods, limitations & source review
Study limitations
- The primary disability endpoint was neutral; early secondary responder findings do not establish a day-90 benefit.
Publication counts are not counts of independent trials. Reviews, translations and reports sharing participants may overlap. Findings apply to the studied preparation, population and endpoints.
Review depth: Indexed abstract checked
Source access and review scope
Primary indexed abstract and publication metadata checked through Europe PMC on 1 November 2026. Full-text methods not reviewed.
Recorded source-check date: 2026-11-01. This date does not imply a completed systematic review.
Source type: Original journal report
Citation and original source
Original source: 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 8:95-104 2013.
Molekul research summary: https://molekul.io/research/placebo-23009193. Cite the original publication for its findings and this page when referring to Molekul’s summary or evidence appraisal.
Bibliography entry