NCT00799890: SUPREMES

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

Completed Phase 2/Phase 3 Last updated 28 July 2021

What this trial tests

Phase 2/Phase 3 trial testing Sunphenon EGCG in Multiple Sclerosis in 61 participants. Completed in 1 March 2016.

Timeline

1 May 2009

Primary endpoint
1 March 2016

1 March 2016

Quick facts

Lead sponsor	Friedemann Paul
Phase	Phase 2/Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	61
Start date	1 May 2009
Primary completion	1 March 2016
Estimated completion	1 March 2016
Sites	1 location across Germany

Drugs / interventions tested

• Sunphenon EGCG — full drug profile →
• Placebo

Conditions studied

• Multiple Sclerosis — all drugs for Multiple Sclerosis →

Sponsor

Friedemann Paul — full company profile →

Who can join

Adults 18 to 65, any sex, with Multiple Sclerosis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• brain atrophy
  Time frame: 36 months of treatment

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Clinical trials in progressive multiple sclerosis: lessons learned and future perspectives.
   Ontaneda D, Fox RJ, Chataway J. · · 2015 · cited 161× · PMID 25772899 · DOI 10.1016/s1474-4422(14)70264-9
2. Tracking CNS and systemic sources of oxidative stress during the course of chronic neuroinflammation.
   Mossakowski AA, Pohlan J, Bremer D, Lindquist R, et al · · 2015 · cited 76× · PMID 26521072 · DOI 10.1007/s00401-015-1497-x
3. Protective Effect of Epigallocatechin-3-Gallate (EGCG) in Diseases with Uncontrolled Immune Activation: Could Such a Scenario Be Helpful to Counteract COVID-19?
   Menegazzi M, Campagnari R, Bertoldi M, Crupi R, et al · · 2020 · cited 70× · PMID 32708322 · DOI 10.3390/ijms21145171
4. Therapeutic Advances and Future Prospects in Progressive Forms of Multiple Sclerosis.
   Shirani A, Okuda DT, Stüve O. · · 2016 · cited 69× · PMID 26729332 · DOI 10.1007/s13311-015-0409-z
5. Epigallocatechin-3-gallate: a useful, effective and safe clinical approach for targeted prevention and individualised treatment of neurological diseases?
   Mähler A, Mandel S, Lorenz M, Ruegg U, et al · · 2013 · cited 53× · PMID 23418936 · DOI 10.1186/1878-5085-4-5
6. Phytochemicals as inhibitors of tumor necrosis factor alpha and neuroinflammatory responses in neurodegenerative diseases.
   Zahedipour F, Hosseini SA, Henney NC, Barreto GE, et al · · 2022 · cited 40× · PMID 35017414 · DOI 10.4103/1673-5374.332128
7. A Personalized Approach in Progressive Multiple Sclerosis: The Current Status of Disease Modifying Therapies (DMTs) and Future Perspectives.
   D'Amico E, Patti F, Zanghì A, Zappia M. · · 2016 · cited 25× · PMID 27763513 · DOI 10.3390/ijms17101725
8. Pharmacological Approaches to Delaying Disability Progression in Patients with Multiple Sclerosis.
   Wiendl H, Meuth SG. · · 2015 · cited 24× · PMID 26033077 · DOI 10.1007/s40265-015-0411-0