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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00799890

Acronym

SUPREMES

Enrollment

Registered

2008-12-01

Start date

2009-05-31

Completion date

2016-03-31

Last updated

2021-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

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

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.

Interventions

DRUGSunphenon EGCG

200-800mg (1-4 capsules)

DRUGPlacebo

1-4 capsules

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
brain atrophy	36 months of treatment

Secondary

Measure	Time frame
new T2 lesions	36 months of treatment
reduction of the NAA/Cr-ratio in MR-spectroscopy	36 months of treatment
progression of disability such as cognitive disorders	36 months of treatment
number of AEs	36 months of treatment

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 16, 2026