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Completed

NCT Number: NCT00525668

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

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).

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Key information

Conditions

Relapsing-Remitting Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Inflammation Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Nerve Degeneration Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

NeuroCure Clinical Research Center, Charite University, Berlin, Berlin, Germany

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

epigallocatechin-gallate (Sunphenon)

Drug

200 mg twice daily, after 3 months 400 mg twice daily

Placebo

Drug

2 placebo capsules twice daily, after 3 months 4 placebo capsules twice daily

Primary outcomes

  1. 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 outcomes

  1. development of brain atrophy under treatment with EGCG vs. placebo

    Time frame: 18 months

  2. Safety and tolerability

    Time frame: 18 months

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study title

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

Acronym: SuniMS

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Sep 6, 2007
Registry last updated
Jul 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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