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

Sponsor

Charite University, Berlin, Germany (Other)

Overall Status

Completed

CT.gov ID

NCT00525668

Collaborator

(none)

120

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 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

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 :

Sep 1, 2007

Actual Primary Completion Date :

Nov 1, 2012

Actual Study Completion Date :

Nov 1, 2012

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

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

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 [18 months]

Secondary Outcome Measures

development of brain atrophy under treatment with EGCG vs. placebo [18 months]
Safety and tolerability [18 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	NeuroCure Clinical Research Center, Charite University, Berlin	Berlin		Germany	10117
2	Outpatient Clinic for Neuroimmunology at the ECRC, Charite University, Berlin	Berlin		Germany	13125

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