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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

September 4, 2007
February 25, 2013
September 2007
November 2012   (final data collection date for primary outcome measure)
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 ]
number of new T2 lesions on brain MRI performed after 12 months of Sunphenon treatment compared to baseline MRI in the verum arm versus placebo
Complete list of historical versions of study NCT00525668 on ClinicalTrials.gov Archive Site
  • 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 ]
development of brain atrophy under treatment with EGCG vs. placebo
Not Provided
Not Provided
 
Sunphenon Epigallocatechin-gallate (EGCg) in Relapsing-remitting Multiple Sclerosis (SuniMS Study)
Sunphenon EGCg (Epigallocatechin-gallate) 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).

This multicentric, national study investigates the efficacy and safety of EGCG in patients with relapsing-remitting multiple sclerosis.
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Relapsing-remitting Multiple Sclerosis
  • Drug: epigallocatechin-gallate (Sunphenon)
    200 mg twice daily, after 3 months 400 mg twice daily
  • Drug: placebo
    2 placebo capsules twice daily, after 3 months 4 placebo capsules twice daily
  • Active Comparator: verum
    Sunphenon plus glatiramer acetate
    Intervention: Drug: epigallocatechin-gallate (Sunphenon)
  • Active Comparator: placebo
    placebo plus glatiramer acetate
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
November 2012
November 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00525668
2006-006323-39
Yes
Friedemann Paul, Charite University, Berlin, Germany
Charite University, Berlin, Germany
Not Provided
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
Charite University, Berlin, Germany
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP