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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).
This multicentric, national study investigates the efficacy and safety of EGCG in patients with relapsing-remitting multiple sclerosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| verum | Active Comparator | Sunphenon plus glatiramer acetate |
|
| placebo | Active Comparator | placebo plus glatiramer acetate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| epigallocatechin-gallate (Sunphenon) | Drug | 200 mg twice daily, after 3 months 400 mg twice daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| development of brain atrophy under treatment with EGCG vs. placebo | 18 months | |
| Safety and tolerability | 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Judith Bellmann-Strobl, Dr., MD | Experimental and Clinical Research Center, Charite University, Berlin, Germany | Principal Investigator |
| Friedemann Paul, Prof., MD | NeuroCure Clinical Research Center, Charité University, Berlin, Germany | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NeuroCure Clinical Research Center, Charite University, Berlin | Berlin | 10117 | Germany | |||
| Outpatient Clinic for Neuroimmunology at the ECRC, Charite University, Berlin |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33762428 | Derived | Bellmann-Strobl J, Paul F, Wuerfel J, Dorr J, Infante-Duarte C, Heidrich E, Kortgen B, Brandt A, Pfuller C, Radbruch H, Rust R, Siffrin V, Aktas O, Heesen C, Faiss J, Hoffmann F, Lorenz M, Zimmermann B, Groppa S, Wernecke KD, Zipp F. Epigallocatechin Gallate in Relapsing-Remitting Multiple Sclerosis: A Randomized, Placebo-Controlled Trial. Neurol Neuroimmunol Neuroinflamm. 2021 Mar 24;8(3):e981. doi: 10.1212/NXI.0000000000000981. Print 2021 May. |
| Label | URL |
|---|---|
| Homepage of the Outpatient Clinic for Neuroimmunology | View source |
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| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| D009103 | Multiple Sclerosis |
| D007249 | Inflammation |
| D009410 | Nerve Degeneration |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| C045651 | epigallocatechin gallate |
| C074269 | Sunphenon |
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| placebo |
| Drug |
2 placebo capsules twice daily, after 3 months 4 placebo capsules twice daily |
|
| Berlin |
| 13125 |
| Germany |
| Homepage of the NeuroCure Clinical Research Center | View source |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |