Sunphenon in Progressive Forms of Multiple Sclerosis

• Status: Completed
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Charite University, Berlin, Germany; Friedemann Paul
• Collaborator: TAIYO EUROPE
• Treatments: Epigallocatechin gallate

Criteria

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