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Sunphenon Epigallocatechin-gallate (EGCg) in Relapsing-remitting Multiple Sclerosis (SuniMS Study)

NCT00525668 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2021-07-29

No results posted yet for this study

Summary

Hypothesis:

Sunphenon, a green tea extract containing 95% egcg, given daily as oral medication over a period of 18 months has anti-inflammatory and neuroprotective properties in patients with relapsing-remitting multiple sclerosis as assessed by magnetic resonance imaging and clinical examination (EDSS and MSFC).

Conditions

  • Relapsing-remitting Multiple Sclerosis

Interventions

DRUG

epigallocatechin-gallate (Sunphenon)

200 mg twice daily, after 3 months 400 mg twice daily

DRUG

placebo

2 placebo capsules twice daily, after 3 months 4 placebo capsules twice daily

Sponsors & Collaborators

  • Charite University, Berlin, Germany

    lead OTHER

Principal Investigators

  • Judith Bellmann-Strobl, Dr., MD · Experimental and Clinical Research Center, Charite University, Berlin, Germany

  • Friedemann Paul, Prof., MD · NeuroCure Clinical Research Center, Charité University, Berlin, Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2012-11-30
Completion
2012-11-30

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00525668 on ClinicalTrials.gov