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

This study is currently recruiting participants.

Verified November 2010 by Charite University, Berlin, Germany

First Received on September 4, 2007. Last Updated on November 10, 2010 History of Changes

Sponsor:	Charite University, Berlin, Germany
Information provided by:	Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:	NCT00525668

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 I Phase II

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:

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Sunphenon Epigallocatechin gallate

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 ]

Estimated Enrollment:	120
Study Start Date:	September 2007
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 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

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

Contacts

Contact: Judith Bellmann-Strobl, Dr, MD	+49 30 450539040	judith.bellmann-strobl@charite.de
Contact: Friedemann Paul, Dr, MD	+49 30 450539040	friedemann.paul@charite.de

Locations

Germany
Outpatient Clinic for Neuroimmunology at the ECRC, Charite University, Berlin	Recruiting
Berlin, Germany, 13125
Contact: Judith Bellmann-Strobl, Dr, MD +49 30 450 540 660 judith.bellmannn-strobl@charite.de
NeuroCure Clinical Research Center, Charite University, Berlin	Recruiting
Berlin, Germany, 10117
Contact: Friedemann Paul, Dr, MD +49 30 450 539040 friedemann.paul@charite.de

Sponsors and Collaborators

Charite University, Berlin, Germany

Investigators

Principal Investigator:

Judith Bellmann-Strobl, Dr, MD

Experimental and Clinical Research Center, Charite 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, Dr, MD, 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:	November 10, 2010
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 February 09, 2012