Sunphenon in Progressive Forms of Multiple Sclerosis (SUPREMES)

This study is ongoing, but not recruiting participants.
Information provided by:
Charite University, Berlin, Germany Identifier:
First received: November 28, 2008
Last updated: May 20, 2015
Last verified: September 2014

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.

Condition Intervention Phase
Multiple Sclerosis
Drug: Sunphenon EGCG
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • brain atrophy [ Time Frame: 36 months of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • new T2 lesions [ Time Frame: 36 months of treatment ] [ Designated as safety issue: No ]
  • reduction of the NAA/Cr-ratio in MR-spectroscopy [ Time Frame: 36 months of treatment ] [ Designated as safety issue: No ]
  • progression of disability such as cognitive disorders [ Time Frame: 36 months of treatment ] [ Designated as safety issue: No ]
  • number of AEs [ Time Frame: 36 months of treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: May 2009
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sunphenon Drug: Sunphenon EGCG
200-800mg (1-4 capsules)
Other Name: Epigallo Catechin Gallate
Placebo Comparator: Placebo Drug: Placebo
1-4 capsules
Other Name: n.a.

Detailed Description:

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.


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00799890

Charité Universitätsmedizin Berlin (NeuroCure Clinical Research Center)
Berlin, Germany, 10117
Sponsors and Collaborators
Charite University, Berlin, Germany
Principal Investigator: Friedemann Paul, Dr. Charite University (NeuroCure Clinical Research Center)
  More Information

Additional Information:
No publications provided

Responsible Party: Dr. Friedemann Paul, Charite University Berlin Identifier: NCT00799890     History of Changes
Other Study ID Numbers: SUPREMES-01
Study First Received: November 28, 2008
Last Updated: May 20, 2015
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Charite University, Berlin, Germany:
primary or secondary chronic-progressive
sunphenon egcg
brain atrophy
T2 lesions

Additional relevant MeSH terms:
Multiple Sclerosis, Chronic Progressive
Multiple Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes
Epigallocatechin gallate
Anticarcinogenic Agents
Antimutagenic Agents
Antineoplastic Agents
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Neuroprotective Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses processed this record on October 08, 2015