Sunphenon in Progressive Forms of Multiple Sclerosis

Phase 2

Completed

• Conditions: Multiple Sclerosis
• Interventions: Drug: Placebo; Drug: Sunphenon EGCG

• Registration Number: NCT00799890
• Lead Sponsor: Friedemann Paul

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.

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 Timeline

• Study First Submitted: 2008-11-28
• Study First Submitted QC: 2008-11-28
• Study First Posted: 2008-12-01
• Study Start: 2009-05
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-28
• Last Update Posted: 2021-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Sunphenon	Sunphenon EGCG	-

Primary Outcome Measures

Name	Time	Method
brain atrophy	36 months of treatment

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Charité Universitätsmedizin Berlin (NeuroCure Clinical Research Center); 🇩🇪 Berlin, Germany