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Methodological Quality of Clinical Trials in Amyotrophic Lateral Sclerosis: A Systematic Review.


ABSTRACT:

Background

More than 200 clinical trials have been performed worldwide in ALS so far, but no agents with substantial efficacy on disease progression have been found.

Objective

To describe the methodological quality of all clinical trials performed in ALS and published before December 31, 2022.

Methods

We conducted a systematic review following the Preferred Reporting Items for Systematic Reviews and Meta Analyses.

Results

213 trials were included. 47.4% manuscripts described preclinical study evaluation, with a positive effect in all. 67.6% of trials were conducted with a parallel-arm design, while 12.7% were cross-over studies; 77% were randomized, while in 5.6% historical-controls were used for comparison. 70% of trials were double blind. Participant inclusio

SUBMITTER: Pupillo E 

PROVIDER: S-EPMC11307009 | biostudies-literature | 2024

REPOSITORIES: biostudies-literature