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

July 28, 2021 updated by: Friedemann Paul, Charite University, Berlin, Germany

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This multicentric, national study investigates the efficacy and safety of EGCG in patients with relapsing-remitting multiple sclerosis.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • NeuroCure Clinical Research Center, Charite University, Berlin
      • Berlin, Germany, 13125
        • Outpatient Clinic for Neuroimmunology at the ECRC, Charite University, Berlin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • male and female subjects age 18 to 60
  • relapsing-remitting course of MS
  • stable treatment with glatiramer acetate at least 6 months prior to inclusion

Exclusion Criteria:

  • primary or secondary progressive forms of MS
  • clinically relevant heart, lung, liver, kidney diseases
  • regular hepatotoxic co-medication
  • drug addiction
  • alcohol abuse

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: verum
Sunphenon plus glatiramer acetate
Drug: epigallocatechin-gallate (Sunphenon)
200 mg twice daily, after 3 months 400 mg twice daily
ACTIVE_COMPARATOR: placebo
placebo plus glatiramer acetate
Drug: placebo
2 placebo capsules twice daily, after 3 months 4 placebo capsules twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
number of new T2 lesions on brain MRI performed after 18 months of Sunphenon treatment compared to baseline MRI in the verum arm versus placebo
Time Frame: 18 months
18 months

Secondary Outcome Measures

Outcome Measure
Time Frame
development of brain atrophy under treatment with EGCG vs. placebo
Time Frame: 18 months
18 months
Safety and tolerability
Time Frame: 18 months
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Investigators

  • Principal Investigator: Judith Bellmann-Strobl, Dr., MD, Experimental and Clinical Research Center, Charite University, Berlin, Germany
  • Study Director: Friedemann Paul, Prof., MD, NeuroCure Clinical Research Center, Charité University, Berlin, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (ACTUAL)

November 1, 2012

Study Completion (ACTUAL)

November 1, 2012

Study Registration Dates

First Submitted

September 4, 2007

First Submitted That Met QC Criteria

September 5, 2007

First Posted (ESTIMATE)

September 6, 2007

Study Record Updates

Last Update Posted (ACTUAL)

July 29, 2021

Last Update Submitted That Met QC Criteria

July 28, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2006-006323-39

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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