A randomized double-blind clinical trial on safety and efficacy of tauroursodeoxycholic acid (TUDCA) as add-on treatment in patients affected by amyotrophic lateral sclerosis (ALS): the statistical analysis plan of TUDCA-ALS trial.

Flavia L LombardoStefania Spila AlegianiFlavia MayerMarta CiprianiMaria Lo GiudiceAlbert Christian LudolphChristopher J McDermottPhilippe CorciaPhilip Van DammeLeonard H Van den BergOrla HardimanGabriele NicoliniNicola VanacoreBrian DickieAlberto AlbaneseMaria Puopolonull null

Published in: Trials (2023)

ClinicalTrials.gov NCT03800524 . Registered on January 11, 2019.

Keyphrases

amyotrophic lateral sclerosis
clinical trial
phase iii
phase ii
double blind
study protocol
placebo controlled
open label
randomized controlled trial