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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00525668
Recruitment Status : Completed
First Posted : September 6, 2007
Last Update Posted : April 15, 2020
Sponsor:
Information provided by (Responsible Party):
Friedemann Paul, Charite University, Berlin, Germany

Tracking Information
First Submitted Date  ICMJE September 4, 2007
First Posted Date  ICMJE September 6, 2007
Last Update Posted Date April 15, 2020
Study Start Date  ICMJE September 2007
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 30, 2009)
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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 5, 2007)
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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 30, 2009)
  • development of brain atrophy under treatment with EGCG vs. placebo [ Time Frame: 18 months ]
  • Safety and tolerability [ Time Frame: 18 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 5, 2007)
development of brain atrophy under treatment with EGCG vs. placebo
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sunphenon Epigallocatechin-gallate (EGCg) in Relapsing-remitting Multiple Sclerosis (SuniMS Study)
Official Title  ICMJE Sunphenon EGCg (Epigallocatechin-gallate) in Relapsing-remitting Multiple Sclerosis (SuniMS Study)
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Relapsing-remitting Multiple Sclerosis
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: verum
    Sunphenon plus glatiramer acetate
    Intervention: Drug: epigallocatechin-gallate (Sunphenon)
  • Active Comparator: placebo
    placebo plus glatiramer acetate
    Intervention: Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 10, 2010)
120
Original Estimated Enrollment  ICMJE
 (submitted: September 5, 2007)
100
Actual Study Completion Date  ICMJE November 2012
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00525668
Other Study ID Numbers  ICMJE 2006-006323-39
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Friedemann Paul, Charite University, Berlin, Germany
Study Sponsor  ICMJE Charite University, Berlin, Germany
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Charite University, Berlin, Germany
Verification Date April 2020

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