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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Friedemann Paul, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00525668
First received: September 4, 2007
Last updated: February 25, 2013
Last verified: February 2013
History of Changes
  Purpose

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).


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Sunphenon EGCg (Epigallocatechin-gallate) in Relapsing-remitting Multiple Sclerosis (SuniMS Study)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • development of brain atrophy under treatment with EGCG vs. placebo [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Safety and tolerability [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00525668

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

Additional Information:
Homepage of the Outpatient Clinic for Neuroimmunology  This link exits the ClinicalTrials.gov site
Homepage of the NeuroCure Clinical Research Center  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Friedemann Paul, Prof., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT00525668     History of Changes
Other Study ID Numbers: 2006-006323-39
Study First Received: September 4, 2007
Last Updated: February 25, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Charite University, Berlin, Germany:
multiple sclerosis
inflammation
neurodegeneration
neuroprotection

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Epigallocatechin gallate
 Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Antimutagenic Agents
Anticarcinogenic Agents
Antineoplastic Agents
Therapeutic Uses
Neuroprotective Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 19, 2013