Clinical Trial Details
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NCT02008721 : Progression Rate of MSA Under EGCG Supplementation as Anti-Aggregation-Approach
PhasePhase 3
AgesMin: 18 Years Max: N/A
Inclusion Criteria:

1. "clinical possible" or "clinical probable" MSA (Gilman et al., Neurology, 2008

2. Hoehn & Yahr stage I - III

3. A stable regimen for at least 1 month prior to V1 and willingness / no fore-seeable
need to change the regimen throughout the 52 week follow-up pe-riod for

1. drugs acting against Parkinsonism (e.g. Levodopa, Dopamine-Agonists, Amantadine
and MAO-B-Inhibitors)

2. drugs acting against autonomic dysfunction (e.g. ephedrin, midodrin,
fludrucortison, octreotide, desmopresin, oxybutinine)

3. antidepressant and antidementive drugs.

4. No regular consumption of EGCG, green tea, or more than two cups of black tea per day

5. Capability and willingness to give written informed consent indicating that the
subject has been informed of and understood all aspects pertinent to the study

6. Capability and willingness to comply with the procedures of the study

7. Contraception by adequate contraceptive methods (oral, injected or im-planted
hormonal contraceptive methods, intrauterine pessar, sterilisation or real
abstinence) in all female patients with childbearing potential

8. Absence of liver disease documented by transaminases and bilirubin below 2-folds of
the upper normal level.

Exclusion Criteria:

1. Hoehn & Yahr stage > III (loss of postural reflexes, no independent walking possible,
inability to stand unassisted, wheelchair-bound).

2. Neurodegenerative diseases other than MSA

3. Severe liver disease with elevation of transaminases and bilirubin above 2-folds of
the upper normal level or regular intake of hepatotoxic drugs

4. Known hypersensitivity to EGCG or to drugs with similar chemical structure

5. Participation in another clinical trial involving administration of an
investigational medicinal product within 1 month prior to V1

6. A physical or psychiatric condition, which at the investigator's discretion may put
the subject at risk, may confound the trial results, or may interfere with the
subject's participation in this clinical trial

7. Persistent abuse of medication, drugs or alcohol

8. Consumption of > 500 ml grapefruit juice per day (leading to inhibition of cytochrome
P-450 isoenzyme 3A4, which may be involved in degradation of EGCG).

9. Current or planned pregnancy or breast feeding in females

10. Females of childbearing potential, who are not using medically reliable methods of
contraception for the entire study duration (such as oral, inject-able, or
implantable contraceptives, or intrauterine contraceptive devices).

11. Intake of COMT-inhibitors (e.g. Entacapone, Tolcapone)

12. Current or planned therapy with Bortezomib and/ or history of plasmocytoma.

13. Anemia at Screening (Hb < 10g/dl)

14. Other severe medical conditions upon discretion of the LKP
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