NCT00525668: SuniMS

Sunphenon EGCg (Epigallocatechin-gallate) in Relapsing-remitting Multiple Sclerosis (SuniMS Study)

Completed Phase 1/Phase 2 Last updated 28 July 2021

What this trial tests

Phase 1/Phase 2 trial testing epigallocatechin-gallate (Sunphenon) in Relapsing-remitting Multiple Sclerosis in 120 participants. Completed in 1 November 2012.

Timeline

1 September 2007

Primary endpoint
1 November 2012

1 November 2012

Quick facts

Lead sponsor	Charite University, Berlin, Germany
Phase	Phase 1/Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	120
Start date	1 September 2007
Primary completion	1 November 2012
Estimated completion	1 November 2012
Sites	2 locations across Germany

Drugs / interventions tested

• epigallocatechin-gallate (Sunphenon) — full drug profile →
• placebo

Conditions studied

• Relapsing-remitting Multiple Sclerosis — all drugs for Relapsing-remitting Multiple Sclerosis →

Sponsor

Charite University, Berlin, Germany

Who can join

Adults 18 to 60, any sex, with Relapsing-remitting 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.

• number of new T2 lesions on brain MRI performed after 18 months of Sunphenon treatment compared to baseline MRI in the verum arm versus placebo
  Time frame: 18 months

Sponsor's own description

Hypothesis:

Sunphenon, a green tea extract containing 95% egcg, given daily as oral medication over a period of 18 months has anti-inflammatory and neuroprotective properties in patients with relapsing-remitting multiple sclerosis as assessed by magnetic resonance imaging and clinical examination (EDSS and MSFC).

Publications & conference data

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

1. New pharmacological strategies for treatment of Alzheimer's disease: focus on disease modifying drugs.
   Salomone S, Caraci F, Leggio GM, Fedotova J, et al · · 2012 · cited 197× · PMID 22035455 · DOI 10.1111/j.1365-2125.2011.04134.x
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. 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
4. Epigallocatechin Gallate in Relapsing-Remitting Multiple Sclerosis: A Randomized, Placebo-Controlled Trial.
   Bellmann-Strobl J, Paul F, Wuerfel J, Dörr J, et al · · 2021 · cited 22× · PMID 33762428 · DOI 10.1212/nxi.0000000000000981
5. New insights in the mechanisms of impaired redox signaling and its interplay with inflammation and immunity in multiple sclerosis.
   Michaličková D, Šíma M, Slanař O. · · 2020 · cited 22× · PMID 31852206 · DOI 10.33549/physiolres.934276
6. In vivo and in vitro perspectives in Parkinson's disease: Mechanisms and the role of phytomedicine.
   Singh J, Kumar D. · · 2025 · cited 1× · PMID 41066749 · DOI 10.38212/2224-6614.3557
7. Phytochemicals as modulators of dendritic cell functions: implications for tolerogenic cell-based therapy.
   Fekete T, Pázmándi K. · · 2025 · PMID 41306974 · DOI 10.3389/fimmu.2025.1653803
8. Concomitant Use of Neuroprotective Drugs in Neuro Rehabilitation of Multiple Sclerosis.
   Dasari H, Wootla B, Warrington AE, Rodriguez M. · · 2016 · PMID 27595123 · DOI 10.4172/2329-9096.1000348