Sunphenon in Progressive Forms of Multiple Sclerosis

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Drug: Sunphenon EGCG
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sunphenon<br> | Drug: Sunphenon EGCG<br>* 200-800mg (1-4 capsules)<br>* Other names: Epigallo Catechin Gallate;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* 1-4 capsules<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| brain atrophy |  | 36 months of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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primary or secondary chronic-progressive, sunphenon egcg, brain atrophy, T2 lesions