Study type: Human research · Status: Verified against declared source

Add-on treatment with Cerebrolysin improves clinical symptoms in patients with ALS: results from a prospective, single-center, placebo-controlled, randomized, double-blind, phase II study.

Journal of medicine and life · 2023

Study scale: Functional impairment, measured by the change in ALSFRS-R score from baseline to Month 1, was the primary outcome measure for the study.

Abstract only: Open source record

Product or molecular entity relationships

Cerebrolysin: Exact entity relationship. Legacy citation custody associates this source with the catalog record; no product-relevance conclusion is implied.

Plain-language verified summary

Question

Despite extensive research efforts, there is currently no cure for ALS.

Methods

All efficacy analyses were performed on the intention-to-treat (ITT) population, which included all randomized patients who received at least one dose of the study drug (Cerebrolysin/placebo) and completed at least one post-baseline assessment.

Scale or participants

Functional impairment, measured by the change in ALSFRS-R score from baseline to Month 1, was the primary outcome measure for the study.

Key findings

Amyotrophic lateral sclerosis (ALS) is a devastating and progressive neurodegenerative disease with limited treatment options available.

Limitations and uncertainty

The small sample size, a major limitation of this study, did not allow analysis of certain subgroups, such as rapidly progressing patients.

Verified against declared source. Verification is limited to the declared source and review scope. It does not mean independent replication or establish efficacy, safety, or suitability.