Sunphenon in Progressive Forms of Multiple Sclerosis (SUPREMES)

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. Identifier: NCT00799890
Recruitment Status : Completed
First Posted : December 1, 2008
Last Update Posted : March 20, 2018
Information provided by:
Charite University, Berlin, Germany

November 28, 2008
December 1, 2008
March 20, 2018
May 2009
March 2016   (Final data collection date for primary outcome measure)
brain atrophy [ Time Frame: 36 months of treatment ]
brain atrophy [ Time Frame: after 30 months of treatment ]
Complete list of historical versions of study NCT00799890 on Archive Site
  • new T2 lesions [ Time Frame: 36 months of treatment ]
  • reduction of the NAA/Cr-ratio in MR-spectroscopy [ Time Frame: 36 months of treatment ]
  • progression of disability such as cognitive disorders [ Time Frame: 36 months of treatment ]
  • number of AEs [ Time Frame: 36 months of treatment ]
  • new T2 lesions [ Time Frame: after 30 months of treatment ]
  • redution of the NAA/Cr-ratio in MR-spectroscopy [ Time Frame: after 30 months of treatment ]
  • progression of disability such as cognitive disorders [ Time Frame: after 30 months of treatment ]
  • safety and tolerability of verum treatment [ Time Frame: at every visit and inbetween ]
Not Provided
Not Provided
Sunphenon in Progressive Forms of Multiple Sclerosis
Monocentric, Prospective, Doubleblind, Randomised/Stratified, Placebocontrolled Two-arm Study to Evaluate the Effect of Sunphenon EGCg (Main Component Epigallocatechin-Gallat) on the Increase of Brain Atrophy in the Cerebral Magnetic Resonance Tomography in a 36-months Treatment Time in Patients With Primary or Secondary Chronic-progressive Multiple Sclerosis
The investigators hypothesize that an oral Sunphenon EGCg (Epigallocatechin-Gallat, EGCG) treatment is - due to its antiinflamatoric and neuroprotective potence - significantly more effective than an oral placebo treatment regarding following parameters: increase in brain atrophy, number of new T2-lesions in the cerebral magnetic resonance tomography, reduction of the NAA/Cr-ratio in MR-spectroscopy, progression of disability such as cognitive disorders in patients with MS.

The hypotheses of our study are:

Sunphenon EGCg has an antiinflammatoric effect due to its impact on the T-cell-proliferation and the inhibition of the activity of NF-Kb.

Sunphenon EGCg has a neuroprotective effect due to its antioxidative potence as a radical scavenger.

A 30 month treatment with Sunphenon EGCg is safe and well-tolerated.

Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Multiple Sclerosis
  • Drug: Sunphenon EGCG
    200-800mg (1-4 capsules)
    Other Name: Epigallo Catechin Gallate
  • Drug: Placebo
    1-4 capsules
  • Experimental: Sunphenon
    Intervention: Drug: Sunphenon EGCG
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
March 2016
March 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Primary or secondary chronic progressive multiple sclerosis (ms)
  • EDSS 3-8
  • Age 18-65

Exclusion Criteria:

  • Relapsing-remitting ms
  • Immunodulatoric or immunosuppressive therapy
  • pretreatment with Mitoxantron, Natalizumab, Rituximab, Azathioprin <2 month before screening
  • pretreatment with Glairameracetat or beta-Interferons <4 weeks before screening
  • signs of hepatic dysfunction
  • active ulcus ventriculi or duodeni
  • neoplasias if not cured >1 year before screening
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Dr. Friedemann Paul, Charite University Berlin
Charite University, Berlin, Germany
Principal Investigator: Friedemann Paul, Dr. Charite University (NeuroCure Clinical Research Center)
Charite University, Berlin, Germany
December 2017

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