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Sunphenon in Progressive Forms of Multiple Sclerosis (SUPREMES)

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Sunphenon EGCG
Placebo
Sponsored by
Friedemann Paul
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring primary or secondary chronic-progressive, sunphenon egcg, brain atrophy, T2 lesions

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Charité Universitätsmedizin Berlin (NeuroCure Clinical Research Center)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Sunphenon

Placebo

Arm Description

Outcomes

Primary Outcome Measures

brain atrophy

Secondary Outcome Measures

new T2 lesions
reduction of the NAA/Cr-ratio in MR-spectroscopy
progression of disability such as cognitive disorders
number of AEs

Full Information

First Posted
November 28, 2008
Last Updated
July 28, 2021
Sponsor
Friedemann Paul
Collaborators
TAIYO EUROPE
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1. Study Identification

Unique Protocol Identification Number
NCT00799890
Brief Title
Sunphenon in Progressive Forms of Multiple Sclerosis
Acronym
SUPREMES
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 Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Friedemann Paul
Collaborators
TAIYO EUROPE

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
primary or secondary chronic-progressive, sunphenon egcg, brain atrophy, T2 lesions

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sunphenon
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Sunphenon EGCG
Other Intervention Name(s)
Epigallo Catechin Gallate
Intervention Description
200-800mg (1-4 capsules)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
1-4 capsules
Primary Outcome Measure Information:
Title
brain atrophy
Time Frame
36 months of treatment
Secondary Outcome Measure Information:
Title
new T2 lesions
Time Frame
36 months of treatment
Title
reduction of the NAA/Cr-ratio in MR-spectroscopy
Time Frame
36 months of treatment
Title
progression of disability such as cognitive disorders
Time Frame
36 months of treatment
Title
number of AEs
Time Frame
36 months of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Friedemann Paul, Dr.
Organizational Affiliation
Charite University (NeuroCure Clinical Research Center)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charité Universitätsmedizin Berlin (NeuroCure Clinical Research Center)
City
Berlin
ZIP/Postal Code
10117
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
33995239
Citation
Klumbies K, Rust R, Dorr J, Konietschke F, Paul F, Bellmann-Strobl J, Brandt AU, Zimmermann HG. Retinal Thickness Analysis in Progressive Multiple Sclerosis Patients Treated With Epigallocatechin Gallate: Optical Coherence Tomography Results From the SUPREMES Study. Front Neurol. 2021 Apr 28;12:615790. doi: 10.3389/fneur.2021.615790. eCollection 2021.
Results Reference
derived
PubMed Identifier
33622766
Citation
Rust R, Chien C, Scheel M, Brandt AU, Dorr J, Wuerfel J, Klumbies K, Zimmermann H, Lorenz M, Wernecke KD, Bellmann-Strobl J, Paul F. Epigallocatechin Gallate in Progressive MS: A Randomized, Placebo-Controlled Trial. Neurol Neuroimmunol Neuroinflamm. 2021 Feb 23;8(3):e964. doi: 10.1212/NXI.0000000000000964. Print 2021 May.
Results Reference
derived
Links:
URL
http://www.charite.de/
Description
Related Info
URL
http://www.ncrc.de
Description
Related Info

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Sunphenon in Progressive Forms of Multiple Sclerosis

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