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NCT00525668 Clinical Trial

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

Relapsing-remitting Multiple Sclerosis Clinical Trial

— SuniMS  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00525668
Other study ID # 2006-006323-39
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date September 2007
Est. completion date November 2012

Study information
Verified date July 2021
Source Charite University, Berlin, Germany
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 120
Est. completion date November 2012
Est. primary completion date November 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• epigallocatechin-gallate (Sunphenon)
200 mg twice daily, after 3 months 400 mg twice daily
• placebo
2 placebo capsules twice daily, after 3 months 4 placebo capsules twice daily

Locations
Country Name City State
Germany NeuroCure Clinical Research Center, Charite University, Berlin Berlin
Germany Outpatient Clinic for Neuroimmunology at the ECRC, Charite University, Berlin Berlin

Sponsors (1)
Lead Sponsor Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 development of brain atrophy under treatment with EGCG vs. placebo 18 months
Secondary Safety and tolerability 18 months
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