Session Information
Date: Thursday, June 8, 2017
Session Title: Clinical Trials and Therapy in Movement Disorders
Session Time: 1:15pm-2:45pm
Location: Exhibit Hall C
Objective: In the PROMESA trial (ClinicalTrials Identifier: NCT02008721) Epigallocatechingallate (EGCG) a catechine that prevents pathological protein aggregation in vitro and can be purified from green tea leaves is tested against placebo in daily doses between 400 and 1200 mgs administered orally one hour before or after last food intake in gelatin-hard capsules containing 400 mgs EGCG each. Subjects are treated for 48 weeks with EGCG. Here we report on the serious adverse reactions during the ongoing study.
Background: Several lines of evidence including epidemiological, in vitro, and in vivo data, suggest that Epigallocatechin gallate (EGCG) might be able to delay disease progression of MSA by modifying several aspects in the pathogenesis of MSA including protein aggregation.
Methods: To assess the efficacy, safety and tolerability of EGCG vs. placebo regarding the reduction of disease progression measured during the study period (80% power, 5% p-level, 50% effect size), considering a drop-out rate of 20%, 86 patients had to be recruited in this multicentric study. Because of high interest of screened participants finally 92 patients were included within the recruitment period from January 2014 till August 2015.
Results: 32 SAEs were reported in total until March 2016. SAEs due to MSA-related symptoms (falls, swallowing problems, urinary tract infections, orthostatic problems and disease progression) were excluded as SAEs and listed as AEs. Two SAEs were initially assessed as potentially related to study drug (fatal gastrointestinal bleeding (SUSAR), elevation of hepatic enzymes (SAR)). The SUSAR was rated unrelated to the study medication by the data safety monitoring committee secondary to an evaluation of autopsy samples by an expert pathologist. Six SAEs with fatal outcome (death of the patient) were reported which are related to vegetative dysfunction (sudden cardiac death, urinary tract infection, asphyxia) and respiratory failure.
Conclusions: Preliminary data of the PROMESA-study suggest a safe pharmacological profile apart from individual cases of hepatotoxicity which can be controlled by determining serum liver parameters.
To cite this abstract in AMA style:
M. Schuberth, J. Levin, S. Maaß, G. Respondek, K. Bötzel, G. Höglinger. PROMESA: Progression Rate of MSA under EGCG Supplementation as anti-Aggregation-Approach – evaluation of serious adverse events [abstract]. Mov Disord. 2017; 32 (suppl 2). https://www.mdsabstracts.org/abstract/promesa-progression-rate-of-msa-under-egcg-supplementation-as-anti-aggregation-approach-evaluation-of-serious-adverse-events/. Accessed May 11, 2025.« Back to 2017 International Congress
MDS Abstracts - https://www.mdsabstracts.org/abstract/promesa-progression-rate-of-msa-under-egcg-supplementation-as-anti-aggregation-approach-evaluation-of-serious-adverse-events/