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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00525668
Recruitment Status : Completed
First Posted : September 6, 2007
Last Update Posted : December 22, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:


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).

Condition or disease Intervention/treatment Phase
Relapsing-remitting Multiple Sclerosis Drug: epigallocatechin-gallate (Sunphenon) Drug: placebo Phase 1 Phase 2

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Sunphenon EGCg (Epigallocatechin-gallate) in Relapsing-remitting Multiple Sclerosis (SuniMS Study)
Study Start Date : September 2007
Primary Completion Date : November 2012
Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. development of brain atrophy under treatment with EGCG vs. placebo [ Time Frame: 18 months ]
  2. Safety and tolerability [ Time Frame: 18 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00525668

NeuroCure Clinical Research Center, Charite University, Berlin
Berlin, Germany, 10117
Outpatient Clinic for Neuroimmunology at the ECRC, Charite University, Berlin
Berlin, Germany, 13125
Sponsors and Collaborators
Charite University, Berlin, Germany
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
More Information

Additional Information:
Responsible Party: Friedemann Paul, Prof., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT00525668     History of Changes
Other Study ID Numbers: 2006-006323-39
First Posted: September 6, 2007    Key Record Dates
Last Update Posted: December 22, 2017
Last Verified: December 2017

Keywords provided by Friedemann Paul, Charite University, Berlin, Germany:
multiple sclerosis

Additional relevant MeSH terms:
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Glatiramer Acetate
Epigallocatechin gallate
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Antirheumatic Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Antimutagenic Agents
Anticarcinogenic Agents
Antineoplastic Agents
Neuroprotective Agents