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

This study has been completed.
Information provided by (Responsible Party):
Friedemann Paul, Charite University, Berlin, Germany Identifier:
First received: September 4, 2007
Last updated: April 12, 2017
Last verified: April 2017


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 Intervention Phase
Relapsing-remitting Multiple Sclerosis
Drug: epigallocatechin-gallate (Sunphenon)
Drug: placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: Sunphenon EGCg (Epigallocatechin-gallate) in Relapsing-remitting Multiple Sclerosis (SuniMS Study)

Resource links provided by NLM:

Further study details as provided by Friedemann Paul, Charite University, Berlin, Germany:

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

Enrollment: 120
Study Start Date: September 2007
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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 Identifier: NCT00525668     History of Changes
Other Study ID Numbers: 2006-006323-39
Study First Received: September 4, 2007
Last Updated: April 12, 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
Epigallocatechin gallate
Glatiramer Acetate
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antimutagenic Agents
Anticarcinogenic Agents
Antineoplastic Agents
Neuroprotective Agents
Adjuvants, Immunologic
Immunologic Factors
Immunosuppressive Agents
Antirheumatic Agents processed this record on May 25, 2017