Progression Rate of MSA Under EGCG Supplementation as Anti-Aggregation-Approach
Status:
Completed
Trial end date:
2016-12-01
Target enrollment:
Participant gender:
Summary
MSA is a rapidly progressive disorder with an average survival time of about 7 years after
the first clinical manifestation. No potent symptomatic treatment is currently available. A
disease-modifying therapy does not exist either. The growing understanding in recent years of
the underlying pathological mechanisms of the disease allows the development of new treatment
options that have a modifying effect on the disease progression. Therefore, treatments are
urgently required that effect the central underlying pathological mechanism, which appears to
be the intracellular aggregation of toxic oligomers of α-synuclein.
EGCG, a polyphenol found in green tea, has shown to inhibit the formation of toxic
α-synuclein oligomers in vitro and has shown to transform α-synuclein-oligomers in non-toxic
oligomer species. There is also evidence for a neuroprotective effect in MPTP-mouse models of
PD and is an antioxidant and iron chelator. There are currently 63 clinical studies
(http://clinicaltrial.gov) in which EGCG was applied for various indications, such as
Multiple Sclerosis, various forms of cancer and Huntington's disease. All of which have shown
good tolerability and safety with the applied doses of EGCG of up to 1200 mg per day,
demonstrating the safety of the drug under controlled clinical conditions (see 5.3.1 for
hepatotoxicity in uncontrolled conditions).
These data provide a solid rationale for testing in a clinical trial if supplementation of
EGCG can interfere with the core disease mechanism in MSA and consequently retard the
clinical progression of the MSA-related disability.
Phase:
Phase 3
Details
Lead Sponsor:
Dr. Johannes Levin
Collaborators:
Deutsche Parkinson Vereinigung Deutsche Stiftung Neurologie German Center for Neurodegenerative Diseases (DZNE) German Foundation for Neurology ParkinsonFonds Deutschland gGmbH