Ignite Creation Date:
2025-12-24 @ 5:41 PM
Ignite Modification Date:
2026-01-01 @ 9:56 PM
Study NCT ID:
NCT00525668
Status:
COMPLETED
Last Update Posted:
2021-07-29
First Post:
2007-09-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sunphenon Epigallocatechin-gallate (EGCg) in Relapsing-remitting Multiple Sclerosis (SuniMS Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020529', 'term': 'Multiple Sclerosis, Relapsing-Remitting'}, {'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D009410', 'term': 'Nerve Degeneration'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C045651', 'term': 'epigallocatechin gallate'}, {'id': 'C074269', 'term': 'Sunphenon'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-28', 'studyFirstSubmitDate': '2007-09-04', 'studyFirstSubmitQcDate': '2007-09-05', 'lastUpdatePostDateStruct': {'date': '2021-07-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-09-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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', 'timeFrame': '18 months'}], 'secondaryOutcomes': [{'measure': 'development of brain atrophy under treatment with EGCG vs. placebo', 'timeFrame': '18 months'}, {'measure': 'Safety and tolerability', 'timeFrame': '18 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['multiple sclerosis', 'inflammation', 'neurodegeneration', 'neuroprotection'], 'conditions': ['Relapsing-remitting Multiple Sclerosis']}, 'referencesModule': {'references': [{'pmid': '33762428', 'type': 'DERIVED', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'http://www.ncrc.de', 'label': 'Homepage of the NeuroCure Clinical Research Center'}]}, 'descriptionModule': {'briefSummary': 'Hypothesis:\n\nSunphenon, 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).', 'detailedDescription': 'This multicentric, national study investigates the efficacy and safety of EGCG in patients with relapsing-remitting multiple sclerosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* male and female subjects age 18 to 60\n* relapsing-remitting course of MS\n* stable treatment with glatiramer acetate at least 6 months prior to inclusion\n\nExclusion Criteria:\n\n* primary or secondary progressive forms of MS\n* clinically relevant heart, lung, liver, kidney diseases\n* regular hepatotoxic co-medication\n* drug addiction\n* alcohol abuse'}, 'identificationModule': {'nctId': 'NCT00525668', 'acronym': 'SuniMS', 'briefTitle': 'Sunphenon Epigallocatechin-gallate (EGCg) in Relapsing-remitting Multiple Sclerosis (SuniMS Study)', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Sunphenon EGCg (Epigallocatechin-gallate) in Relapsing-remitting Multiple Sclerosis (SuniMS Study)', 'orgStudyIdInfo': {'id': '2006-006323-39'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'verum', 'description': 'Sunphenon plus glatiramer acetate', 'interventionNames': ['Drug: epigallocatechin-gallate (Sunphenon)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'placebo', 'description': 'placebo plus glatiramer acetate', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'epigallocatechin-gallate (Sunphenon)', 'type': 'DRUG', 'description': '200 mg twice daily, after 3 months 400 mg twice daily', 'armGroupLabels': ['verum']}, {'name': 'placebo', 'type': 'DRUG', 'description': '2 placebo capsules twice daily, after 3 months 4 placebo capsules twice daily', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'NeuroCure Clinical Research Center, Charite University, Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '13125', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Outpatient Clinic for Neuroimmunology at the ECRC, Charite University, Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Judith Bellmann-Strobl, Dr., MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Experimental and Clinical Research Center, Charite University, Berlin, Germany'}, {'name': 'Friedemann Paul, Prof., MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'NeuroCure Clinical Research Center, Charité University, Berlin, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'Friedemann Paul', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}