SUPREMES: Sunphenon in Progressive Forms of Multiple Sclerosis

Sponsor

Friedemann Paul (Other)

Overall Status

Completed

CT.gov ID

NCT00799890

Collaborator

TAIYO EUROPE (Other)

Enrollment

Location

Arms

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The investigators hypothesize that an oral Sunphenon EGCg (Epigallocatechin-Gallat, EGCG) treatment is - due to its antiinflamatoric and neuroprotective potence - significantly more effective than an oral placebo treatment regarding following parameters: increase in brain atrophy, number of new T2-lesions in the cerebral magnetic resonance tomography, reduction of the NAA/Cr-ratio in MR-spectroscopy, progression of disability such as cognitive disorders in patients with MS.

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis	Drug: Sunphenon EGCG Drug: Placebo	Phase 2/Phase 3

Detailed Description

The hypotheses of our study are:

Sunphenon EGCg has an antiinflammatoric effect due to its impact on the T-cell-proliferation and the inhibition of the activity of NF-Kb.

Sunphenon EGCg has a neuroprotective effect due to its antioxidative potence as a radical scavenger.

A 30 month treatment with Sunphenon EGCg is safe and well-tolerated.

Study Design

Study Type:

Interventional

Actual Enrollment :

61 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Monocentric, Prospective, Doubleblind, Randomised/Stratified, Placebocontrolled Two-arm Study to Evaluate the Effect of Sunphenon EGCg (Main Component Epigallocatechin-Gallat) on the Increase of Brain Atrophy in the Cerebral Magnetic Resonance Tomography in a 36-months Treatment Time in Patients With Primary or Secondary Chronic-progressive Multiple Sclerosis

Study Start Date :

May 1, 2009

Actual Primary Completion Date :

Mar 1, 2016

Actual Study Completion Date :

Mar 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sunphenon	Drug: Sunphenon EGCG 200-800mg (1-4 capsules) Other Names: Epigallo Catechin Gallate
Placebo Comparator: Placebo	Drug: Placebo 1-4 capsules

Arm

Intervention/Treatment

Experimental: Sunphenon

Drug: Sunphenon EGCG

200-800mg (1-4 capsules)

Other Names:

Epigallo Catechin Gallate

Placebo Comparator: Placebo

Drug: Placebo

1-4 capsules

Outcome Measures

Primary Outcome Measures

brain atrophy [36 months of treatment]

Secondary Outcome Measures

new T2 lesions [36 months of treatment]
reduction of the NAA/Cr-ratio in MR-spectroscopy [36 months of treatment]
progression of disability such as cognitive disorders [36 months of treatment]
number of AEs [36 months of treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Primary or secondary chronic progressive multiple sclerosis (ms)
EDSS 3-8
Age 18-65

Exclusion Criteria:

Relapsing-remitting ms
Immunodulatoric or immunosuppressive therapy
pretreatment with Mitoxantron, Natalizumab, Rituximab, Azathioprin <2 month before screening
pretreatment with Glairameracetat or beta-Interferons <4 weeks before screening
signs of hepatic dysfunction
active ulcus ventriculi or duodeni
neoplasias if not cured >1 year before screening