Sunphenon in Progressive Forms of Multiple Sclerosis (SUPREMES)

Friedemann Paul

Status and phase

Completed

Phase 3

Phase 2

Conditions

Multiple Sclerosis

Treatments

Drug: Placebo

Drug: Sunphenon EGCG

Study type

Interventional

Funder types

Other

Identifiers

NCT00799890

SUPREMES-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

61 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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