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Sunphenon in Progressive Forms of Multiple Sclerosis (SUPREMES)

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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

Tracking Information
First Submitted Date  ICMJE November 28, 2008
First Posted Date  ICMJE December 1, 2008
Last Update Posted Date July 29, 2021
Study Start Date  ICMJE May 2009
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 22, 2014)
brain atrophy [ Time Frame: 36 months of treatment ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 28, 2008)
brain atrophy [ Time Frame: after 30 months of treatment ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 22, 2014)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 28, 2008)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sunphenon in Progressive Forms of Multiple Sclerosis
Official Title  ICMJE 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
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Multiple Sclerosis
Intervention  ICMJE
  • Drug: Sunphenon EGCG
    200-800mg (1-4 capsules)
    Other Name: Epigallo Catechin Gallate
  • Drug: Placebo
    1-4 capsules
Study Arms  ICMJE
  • Experimental: Sunphenon
    Intervention: Drug: Sunphenon EGCG
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications *

*   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: April 14, 2020)
61
Original Estimated Enrollment  ICMJE
 (submitted: November 28, 2008)
60
Actual Study Completion Date  ICMJE March 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older 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 NCT00799890
Other Study ID Numbers  ICMJE SUPREMES-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Friedemann Paul, Charite University, Berlin, Germany
Study Sponsor  ICMJE Friedemann Paul
Collaborators  ICMJE TAIYO EUROPE
Investigators  ICMJE
Principal Investigator: Friedemann Paul, Dr. Charite University (NeuroCure Clinical Research Center)
PRS Account Charite University, Berlin, Germany
Verification Date July 2021

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