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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2012-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Sunphenon in Progressive Forms of Multiple Sclerosis

NCT00799890

Multiple Sclerosis

COMPLETED PHASE2/PHASE3

Safety and Brain Protection Effects of the Green Tea Extract Theaphenon 95% (95% Pure EGCG) in Multiple Sclerosis

NCT02011451

Multiple Sclerosis

WITHDRAWN PHASE2

Metabolic Effects of a Green Tea Extract in Multiple Sclerosis Patients

NCT01417312

Multiple Sclerosis, Relapsing-Remitting

COMPLETED NA

Natural Antioxidants in the Treatment of Multiple Sclerosis

NCT00010842

Multiple Sclerosis

COMPLETED PHASE1/PHASE2

Safety of Polyphenon E in Multiple Sclerosis Pilot Study

NCT00836719

Multiple Sclerosis

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Relapsing-remitting Multiple Sclerosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

verum

Sunphenon plus glatiramer acetate

Group Type ACTIVE_COMPARATOR

epigallocatechin-gallate (Sunphenon)

Intervention Type DRUG

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

placebo

placebo plus glatiramer acetate

Group Type ACTIVE_COMPARATOR

placebo

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

epigallocatechin-gallate (Sunphenon)

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

Intervention Type DRUG

placebo

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No