Evidence map›Paper›PMID 26809243›Full record

Trial reportJournal of neural transmission (Vienna, Austria : 1996)2016

The PROMESA-protocol: progression rate of multiple system atrophy under EGCG supplementation as anti-aggregation-approach.

Johannes Levin, Sylvia Maaß, Madeleine Schuberth, Gesine Respondek, Friedemann Paul, Ullrich Mansmann, Wolfgang H Oertel, Stefan Lorenzl, Florian Krismer, Klaus Seppi and 6 more

Erratum issuedAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Journal of neural transmission (Vienna, Austria : 1996), 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 23 papers.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed
4.0field-weighted citation impact, top 7% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 38 citations in OpenAlex.

  1. Review
  2. Review
  3. Review
  4. Review
  5. Recent Advances in Clinical Trials in Multiple System Atrophy.Current neurology and neuroscience reports · 2024
    Review
  6. Article
  7. Review
  8. Review
  9. Disease modification in Parkinsonism: obstacles and ways forward.Journal of neural transmission (Vienna, Austria : 1996) · 2022
    Review
  10. Review
  11. Review
  12. Review
  13. Review
  14. Review
  15. Review
  16. Review
  17. Article
  18. Unbiased Screens for Modifiers of Alpha-Synuclein Toxicity.Current neurology and neuroscience reports · 2019
    Review
  19. Review
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

16 authors at 6 institutions in 2 countries.

Johannes LevinDepartment of Neurology, Klinikum Großhadern, Ludwig-Maximilians-Universität, Munich, Germany. jlevin@med.uni-muenchen.de.
Sylvia MaaßGerman Centre for Neurodegenerative Diseases (DZNE), Feodor-Lynen Str. 17, 81377, Munich, Germany.
Madeleine SchuberthDepartment of Neurology, Klinikum Großhadern, Ludwig-Maximilians-Universität, Munich, Germany.
Gesine RespondekGerman Centre for Neurodegenerative Diseases (DZNE), Feodor-Lynen Str. 17, 81377, Munich, Germany.
Friedemann PaulNeuroCure Clinical Research Center and Clinical and Experimental Multiple Sclerosis Research Center, Department of Neurology, Charité University Medicine Berlin, Berlin, Germany.
Ullrich MansmannInstitute for Medical Informatics, Biometry and Epidemiology (IBE), Ludwig-Maximilians-Universität, Munich, Germany.
Wolfgang H OertelDepartment of Neurology, Philipps Universität, Marburg, Germany.
Stefan LorenzlDepartment of Neurology, Klinikum Großhadern, Ludwig-Maximilians-Universität, Munich, Germany.
Florian KrismerDepartment of Neurology, Medical University of Innsbruck, Innsbruck, Austria.
Klaus SeppiDepartment of Neurology, Medical University of Innsbruck, Innsbruck, Austria.
Werner PoeweDepartment of Neurology, Medical University of Innsbruck, Innsbruck, Austria.
Gregor WenningDepartment of Neurology, Medical University of Innsbruck, Innsbruck, Austria.
PROMESA study group
Armin GieseCenter for Neuropathology and Prion Research, Ludwig-Maximilians-Universität, Munich, Germany.
Kai BötzelDepartment of Neurology, Klinikum Großhadern, Ludwig-Maximilians-Universität, Munich, Germany.
Günter HöglingerGerman Centre for Neurodegenerative Diseases (DZNE), Feodor-Lynen Str. 17, 81377, Munich, Germany.
German Center for Neurodegenerative Diseases · DEInnsbruck Medical University · ATLudwig-Maximilians-Universität München · DEPhilipps University of Marburg · DEMax Delbrück Center · DETUM Klinikum · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Formation of toxic α-synuclein oligomers appears to be a key underlying pathological mechanism of synucleinopathies such as Parkinson's disease or multiple system atrophy (MSA). Given that Epigallocatechin-gallate has been shown to inhibit α-synuclein aggregation, it might represent a causal treatment option. Therefore, we set out to evaluate the safety, tolerability and a potential disease-modifying effect of Epigallocatechin-gallate in patients with MSA after 48 weeks of treatment. Power calculation was performed on existing natural history data on the progression of the Unified MSA Rating Scale as primary readout parameter. To assess the efficacy of Epigallocatechin-gallate versus placebo regarding the reduction of disease progression measured during the study period (80 % power, 5 % p level, 50 % effect size) 36 patients per group are needed. Considering a drop-out rate of 20 % a total of 86 patients will be recruited in this multicentre study. These data provide a solid rationale to investigate whether supplementation of Epigallocatechin-gallate can delay the progression of the MSA-related disability.

Indexed as

Research DesignCatechinDisease ProgressionDouble-Blind MethodHumansMultiple System AtrophyNeuroprotective AgentsCatechinepigallocatechin gallateNeuroprotective AgentsEGCGMultiple system atrophyOligomerParkinsonProtein aggregationα-Synuclein

Identifiers

PMID26809243
OpenAlexW2272243439

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.