Sunphenon in Progressive Forms of Multiple Sclerosis (SUPREMES)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
TAIYO EUROPE
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00799890
First received: November 28, 2008
Last updated: September 22, 2014
Last verified: September 2014

November 28, 2008
September 22, 2014
May 2009
May 2015   (final data collection date for primary outcome measure)
brain atrophy [ Time Frame: 36 months of treatment ] [ Designated as safety issue: No ]
brain atrophy [ Time Frame: after 30 months of treatment ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00799890 on ClinicalTrials.gov Archive Site
  • 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 ]
  • new T2 lesions [ Time Frame: after 30 months of treatment ] [ Designated as safety issue: No ]
  • redution of the NAA/Cr-ratio in MR-spectroscopy [ Time Frame: after 30 months of treatment ] [ Designated as safety issue: No ]
  • progression of disability such as cognitive disorders [ Time Frame: after 30 months of treatment ] [ Designated as safety issue: No ]
  • safety and tolerability of verum treatment [ Time Frame: at every visit and inbetween ] [ Designated as safety issue: Yes ]
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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Multiple Sclerosis
  • Drug: Sunphenon EGCG
    200-800mg (1-4 capsules)
    Other Name: Epigallo Catechin Gallate
  • Drug: Placebo
    1-4 capsules
    Other Name: n.a.
  • 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
November 2016
May 2015   (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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00799890
SUPREMES-01
No
Dr. Friedemann Paul, Charite University Berlin
Charite University, Berlin, Germany
TAIYO EUROPE
Principal Investigator: Friedemann Paul, Dr. Charite University (NeuroCure Clinical Research Center)
Charite University, Berlin, Germany
September 2014

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