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CompletedNCT00799890SUPREMESUpdated Jul 29, 2021

Sunphenon in Progressive Forms of Multiple Sclerosis

A Phase 2/3 interventional study of Sunphenon EGCG and Placebo in Multiple Sclerosis, sponsored by Friedemann Paul. Completed at 1 site in Germany. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-07-29.

Sponsored by Friedemann Paul · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
61
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Multiple Sclerosis

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Keywords

  • primary or secondary chronic-progressive
  • sunphenon egcg
  • brain atrophy
  • T2 lesions
03

In context

Multiple Sclerosis

3,524 studies on the registry are indexed under Multiple Sclerosis; 668 are open to participants now.

This study's enrollment of 61 is above the median of 50 across 2,386 interventional studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

Friedemann Paul is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Primary or secondary chronic progressive multiple sclerosis (ms)
  • EDSS 3-8
  • Age 18-65

Exclusion criteria

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
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
61 participants (actual)

Study arms

  • Experimental
    Sunphenon

    Drug: Sunphenon EGCG

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugSunphenon EGCG

    200-800mg (1-4 capsules)

    Also known as: Epigallo Catechin Gallate

  • DrugPlacebo

    1-4 capsules

06

What researchers measure

Primary outcomes

  1. brain atrophy

    Time frame: 36 months of treatment

Secondary outcomes

  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

07

Study locations

1 site
  • Charité Universitätsmedizin Berlin (NeuroCure Clinical Research Center)
    Berlin, 10117, Germany
08

References and documents

Publications

  • 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. PubMed 33995239 ↗
  • 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. PubMed 33622766 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of May 2009, a primary completion of Mar 2016 and a completion of Mar 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 28, 2008
First posted
Dec 1, 2008
Start
May 2009
Primary completionActual
Mar 2016
CompletionActual
Mar 2016
Last update
Jul 29, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 29, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00799890
Lead sponsor
Friedemann Paul
Collaborators
TAIYO EUROPE
Responsible party
Friedemann Paul (Prof. Dr., Charite University, Berlin, Germany) — Sponsor-investigator
First posted
Dec 1, 2008
Start date
May 2009
Primary completion
Mar 2016
Completion
Mar 2016
Last update
Jul 29, 2021

Study contacts

Friedemann Paul, Dr.
principal investigator · Charite University (NeuroCure Clinical Research Center)

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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