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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.
 
ClinicalTrials.gov Identifier: NCT00799890
Recruitment Status : Completed
First Posted : December 1, 2008
Last Update Posted : July 29, 2021
Sponsor:
Collaborator:
TAIYO EUROPE
Information provided by (Responsible Party):
Friedemann Paul, Charite University, Berlin, Germany

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Multiple Sclerosis Drug: Sunphenon EGCG Drug: Placebo Phase 2 Phase 3

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : May 2009
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Sunphenon Drug: Sunphenon EGCG
200-800mg (1-4 capsules)
Other Name: Epigallo Catechin Gallate
Placebo Comparator: Placebo Drug: Placebo
1-4 capsules


Outcome Measures
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Primary Outcome Measures :
  1. brain atrophy [ Time Frame: 36 months of treatment ]

Secondary Outcome Measures :
  1. new T2 lesions [ Time Frame: 36 months of treatment ]
  2. reduction of the NAA/Cr-ratio in MR-spectroscopy [ Time Frame: 36 months of treatment ]
  3. progression of disability such as cognitive disorders [ Time Frame: 36 months of treatment ]
  4. number of AEs [ Time Frame: 36 months of treatment ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00799890


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Friedemann Paul, Prof. Dr., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT00799890    
Other Study ID Numbers: SUPREMES-01
First Posted: December 1, 2008    Key Record Dates
Last Update Posted: July 29, 2021
Last Verified: July 2021
Keywords provided by Friedemann Paul, Charite University, Berlin, Germany:
primary or secondary chronic-progressive
sunphenon egcg
brain atrophy
T2 lesions
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
 Epigallocatechin gallate
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antimutagenic Agents
Anticarcinogenic Agents
Antineoplastic Agents
Neuroprotective Agents