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

Phase 1

Completed

• Conditions: Relapsing-remitting Multiple Sclerosis
• Interventions: Drug: placebo; Drug: epigallocatechin-gallate (Sunphenon)

• Registration Number: NCT00525668
• Lead Sponsor: Charite University, Berlin, Germany

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).

Detailed Description

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

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-09-04
• Study First Submitted QC: 2007-09-05
• Study First Posted: 2007-09-06
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-28
• Last Update Posted: 2021-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	placebo plus glatiramer acetate
verum	epigallocatechin-gallate (Sunphenon)	Sunphenon plus glatiramer acetate

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Safety and tolerability	18 months
development of brain atrophy under treatment with EGCG vs. placebo	18 months

Trial Locations

Locations (2)

NeuroCure Clinical Research Center, Charite University, Berlin; 🇩🇪 Berlin, Germany

Outpatient Clinic for Neuroimmunology at the ECRC, Charite University, Berlin; 🇩🇪 Berlin, Germany