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

Primary Purpose

Relapsing-remitting Multiple Sclerosis

Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
epigallocatechin-gallate (Sunphenon)
placebo
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsing-remitting Multiple Sclerosis focused on measuring multiple sclerosis, inflammation, neurodegeneration, neuroprotection

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • male and female subjects age 18 to 60
  • relapsing-remitting course of MS
  • stable treatment with glatiramer acetate at least 6 months prior to inclusion

Exclusion Criteria:

  • primary or secondary progressive forms of MS
  • clinically relevant heart, lung, liver, kidney diseases
  • regular hepatotoxic co-medication
  • drug addiction
  • alcohol abuse

Sites / Locations

  • NeuroCure Clinical Research Center, Charite University, Berlin
  • Outpatient Clinic for Neuroimmunology at the ECRC, Charite University, Berlin

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

verum

placebo

Arm Description

Sunphenon plus glatiramer acetate

placebo plus glatiramer acetate

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

development of brain atrophy under treatment with EGCG vs. placebo
Safety and tolerability

Full Information

First Posted
September 4, 2007
Last Updated
July 28, 2021
Sponsor
Charite University, Berlin, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT00525668
Brief Title
Sunphenon Epigallocatechin-gallate (EGCg) in Relapsing-remitting Multiple Sclerosis (SuniMS Study)
Acronym
SuniMS
Official Title
Sunphenon EGCg (Epigallocatechin-gallate) in Relapsing-remitting Multiple Sclerosis (SuniMS Study)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).
Detailed Description
This multicentric, national study investigates the efficacy and safety of EGCG in patients with relapsing-remitting multiple sclerosis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsing-remitting Multiple Sclerosis
Keywords
multiple sclerosis, inflammation, neurodegeneration, neuroprotection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
verum
Arm Type
Active Comparator
Arm Description
Sunphenon plus glatiramer acetate
Arm Title
placebo
Arm Type
Active Comparator
Arm Description
placebo plus glatiramer acetate
Intervention Type
Drug
Intervention Name(s)
epigallocatechin-gallate (Sunphenon)
Intervention Description
200 mg twice daily, after 3 months 400 mg twice daily
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
2 placebo capsules twice daily, after 3 months 4 placebo capsules twice daily
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
development of brain atrophy under treatment with EGCG vs. placebo
Time Frame
18 months
Title
Safety and tolerability
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: male and female subjects age 18 to 60 relapsing-remitting course of MS stable treatment with glatiramer acetate at least 6 months prior to inclusion Exclusion Criteria: primary or secondary progressive forms of MS clinically relevant heart, lung, liver, kidney diseases regular hepatotoxic co-medication drug addiction alcohol abuse
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judith Bellmann-Strobl, Dr., MD
Organizational Affiliation
Experimental and Clinical Research Center, Charite University, Berlin, Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Friedemann Paul, Prof., MD
Organizational Affiliation
NeuroCure Clinical Research Center, Charité University, Berlin, Germany
Official's Role
Study Director
Facility Information:
Facility Name
NeuroCure Clinical Research Center, Charite University, Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Outpatient Clinic for Neuroimmunology at the ECRC, Charite University, Berlin
City
Berlin
ZIP/Postal Code
13125
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
33762428
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.
Results Reference
derived
Links:
URL
http://www.ncrc.de
Description
Homepage of the NeuroCure Clinical Research Center

Learn more about this trial

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

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