NCT00525668

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2007

Longer than P75 for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

September 4, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 6, 2007

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

July 29, 2021

Status Verified

July 1, 2021

Enrollment Period

5.2 years

First QC Date

September 4, 2007

Last Update Submit

July 28, 2021

Conditions

Relapsing-remitting Multiple Sclerosis

Keywords

multiple sclerosisinflammationneurodegenerationneuroprotection

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • development of brain atrophy under treatment with EGCG vs. placebo

    18 months

  • Safety and tolerability

    18 months

Study Arms (2)

verum

ACTIVE COMPARATOR

Sunphenon plus glatiramer acetate

Drug: epigallocatechin-gallate (Sunphenon)

placebo

ACTIVE COMPARATOR

placebo plus glatiramer acetate

Drug: placebo

Interventions

epigallocatechin-gallate (Sunphenon)DRUG

200 mg twice daily, after 3 months 400 mg twice daily

verum
placeboDRUG

2 placebo capsules twice daily, after 3 months 4 placebo capsules twice daily

placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • male and female subjects age 18 to 60
  • relapsing-remitting course of MS

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

NeuroCure Clinical Research Center, Charite University, Berlin

Berlin, 10117, Germany

Location

Outpatient Clinic for Neuroimmunology at the ECRC, Charite University, Berlin

Berlin, 13125, Germany

Location

Related Publications (1)

  • 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.

    PMID: 33762428DERIVED

Related Links

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-RemittingMultiple SclerosisInflammationNerve Degeneration

Interventions

epigallocatechin gallateSunphenon

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • 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

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

September 4, 2007

First Posted

September 6, 2007

Study Start

September 1, 2007

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

July 29, 2021

Record last verified: 2021-07

Locations

DE(2)