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: November 13, 2012

Last verified: November 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

November 28, 2008

Last Updated Date

November 13, 2012

Start Date ^ICMJE

April 2009

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

brain atrophy [ Time Frame: after 30 months of treatment ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00799890 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

new T2 lesions [ Time Frame: after 30 months of treatment ] [ Designated as safety issue: No ]
reduction 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 (number of AEs incl. safetylab values) [ Time Frame: assessed at every (unscheduled or scheduled) visit ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

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 ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

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 30-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

Phase 2
Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Primary or Secondary Chronic-progressive Multiple Sclerosis

Intervention ^ICMJE

Drug: Sunphenon EGCG
200-800mg (1-4 capsules)

Other Name: Epigallo Catechin Gallate
Drug: Placebo
1-4 capsules

Other Name: n.a.

Study Arm (s)

Experimental: Sunphenon
Intervention: Drug: Sunphenon EGCG
Placebo Comparator: Placebo
Intervention: Drug: Placebo

Publications *

Not Provided

* 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

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

May 2014

Estimated Primary Completion Date

December 2013 (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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT00799890

Other Study ID Numbers ^ICMJE

SUPREMES-01

Has Data Monitoring Committee

Responsible Party

Dr. Friedemann Paul, Charite University Berlin

Study Sponsor ^ICMJE

Charite University, Berlin, Germany

Collaborators ^ICMJE

TAIYO EUROPE

Investigators ^ICMJE

Principal Investigator:

Friedemann Paul, Dr.

Charite University (NeuroCure Clinical Research Center)

Information Provided By

Charite University, Berlin, Germany

Verification Date

November 2012

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

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