Sunphenon in Progressive Forms of Multiple Sclerosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2016-03-31

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.

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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.

Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Sunphenon

Group Type EXPERIMENTAL

Sunphenon EGCG

Intervention Type DRUG

200-800mg (1-4 capsules)

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

1-4 capsules

Interventions

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Sunphenon EGCG

200-800mg (1-4 capsules)

Intervention Type DRUG

Placebo

1-4 capsules

Intervention Type DRUG

Other Intervention Names

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Epigallo Catechin Gallate

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No