Double blind, randomised, prospective placebo controlled parallel group phase III study to investigate the Effect of EGCG supplementation on disease progression of patients with Multiple System Atrophy (MSA)

Phase 1

• Conditions: Progression of patients with Multiple System Atrophy (MSA); Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2012-000928-18-DE
• Lead Sponsor: Hospital of the Ludwig-Maximilians-University of Munich

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06-28
• Last Update Posted: 5 December 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

1. Clinical signs of MSA. Diagnosis will be made for patients with „clinical possible or „clinical prob-able Multiple System Atrophy (MSA) according to the diagnostic criteria of Gilman et al. (Neurology 2008).
2. Stadium Hoehn & Yahr I – III
3. A stable regimen for at least 1 month prior to V1 and willingness / no foreseeable need to change the regimen throughout the the 52 week follow-up period for
a. drugs acting against Parkinsonism (e.g. Levodopa, Dopamine-Agonists, Amantadine and MAO-B-Inhibitors)
b. other CNS-active substances including antidepressants and antidementive drugs.
c. drugs acting against autonomic dysfunction (e.g. ephedrin, midodrin, fludrucortison, octreo-tide, desmopresin, oxybutinine).
4.Capability and willingness to give written signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study
5. No regular consumption of green tea or EGCG
6. Not more than maximum of two cups black tea /day

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 86
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 86

Exclusion Criteria

1. Clinical signs of MSA exceeding Stadium Hoehn and Yahr 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 above 5folds of the upper normal level or the in-take of hepatotoxic drugs
4. Known hypersensitivity to EGCG or substances with a similar chemical structure
5. Participation in another clinical trial involving administration of an investigational medicinal product within 30 days prior to V0.
6. Known or persistent abuse of medication, drugs or alcohol
7. Subjects with a physical or psychiatric condition that may put the subject at risk, confound trial results or may interfere with the subject’s participation in this clinical trial
8. Consumption of more than 500ml grapefruit juice/day (leading to inhibition of cytochrome P-450 isoen-zyme 3A4, which may be involved in degradation of EGCG)
9. Intake of COMT-Inhibitors (e.g. Entacapone, Tolcapone)
12. Current or planned therapy with bortezomib and/ or history of plasmocytoma
13. Anemia at Screening Visit (Hb < 10g/dl)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified