- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00799890
Sunphenon in Progressive Forms of Multiple Sclerosis (SUPREMES)
July 28, 2021 updated by: Friedemann Paul
Monocentric, Prospective, Doubleblind, Randomised/Stratified, Placebocontrolled Two-arm Study to Evaluate the Effect of Sunphenon EGCg (Main Component Epigallocatechin-Gallat) on the Increase of Brain Atrophy in the Cerebral Magnetic Resonance Tomography in a 36-months Treatment Time in Patients With Primary or Secondary Chronic-progressive Multiple Sclerosis
The investigators hypothesize that an oral Sunphenon EGCg (Epigallocatechin-Gallat, EGCG) treatment is - due to its antiinflamatoric and neuroprotective potence - significantly more effective than an oral placebo treatment regarding following parameters: increase in brain atrophy, number of new T2-lesions in the cerebral magnetic resonance tomography, reduction of the NAA/Cr-ratio in MR-spectroscopy, progression of disability such as cognitive disorders in patients with MS.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The hypotheses of our study are:
Sunphenon EGCg has an antiinflammatoric effect due to its impact on the T-cell-proliferation and the inhibition of the activity of NF-Kb.
Sunphenon EGCg has a neuroprotective effect due to its antioxidative potence as a radical scavenger.
A 30 month treatment with Sunphenon EGCg is safe and well-tolerated.
Study Type
Interventional
Enrollment (Actual)
61
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Berlin, Germany, 10117
- Charité Universitätsmedizin Berlin (NeuroCure Clinical Research Center)
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Primary or secondary chronic progressive multiple sclerosis (ms)
- EDSS 3-8
- Age 18-65
Exclusion Criteria:
- Relapsing-remitting ms
- Immunodulatoric or immunosuppressive therapy
- pretreatment with Mitoxantron, Natalizumab, Rituximab, Azathioprin <2 month before screening
- pretreatment with Glairameracetat or beta-Interferons <4 weeks before screening
- signs of hepatic dysfunction
- active ulcus ventriculi or duodeni
- neoplasias if not cured >1 year before screening
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
1-4 capsules
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Experimental: Sunphenon
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200-800mg (1-4 capsules)
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
brain atrophy
Time Frame: 36 months of treatment
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36 months of treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
new T2 lesions
Time Frame: 36 months of treatment
|
36 months of treatment
|
reduction of the NAA/Cr-ratio in MR-spectroscopy
Time Frame: 36 months of treatment
|
36 months of treatment
|
progression of disability such as cognitive disorders
Time Frame: 36 months of treatment
|
36 months of treatment
|
number of AEs
Time Frame: 36 months of treatment
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36 months of treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Friedemann Paul, Dr., Charite University (NeuroCure Clinical Research Center)
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Klumbies K, Rust R, Dorr J, Konietschke F, Paul F, Bellmann-Strobl J, Brandt AU, Zimmermann HG. Retinal Thickness Analysis in Progressive Multiple Sclerosis Patients Treated With Epigallocatechin Gallate: Optical Coherence Tomography Results From the SUPREMES Study. Front Neurol. 2021 Apr 28;12:615790. doi: 10.3389/fneur.2021.615790. eCollection 2021.
- Rust R, Chien C, Scheel M, Brandt AU, Dorr J, Wuerfel J, Klumbies K, Zimmermann H, Lorenz M, Wernecke KD, Bellmann-Strobl J, Paul F. Epigallocatechin Gallate in Progressive MS: A Randomized, Placebo-Controlled Trial. Neurol Neuroimmunol Neuroinflamm. 2021 Feb 23;8(3):e964. doi: 10.1212/NXI.0000000000000964. Print 2021 May.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2009
Primary Completion (Actual)
March 1, 2016
Study Completion (Actual)
March 1, 2016
Study Registration Dates
First Submitted
November 28, 2008
First Submitted That Met QC Criteria
November 28, 2008
First Posted (Estimate)
December 1, 2008
Study Record Updates
Last Update Posted (Actual)
July 29, 2021
Last Update Submitted That Met QC Criteria
July 28, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Nervous System Diseases
- Immune System Diseases
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Autoimmune Diseases
- Multiple Sclerosis
- Sclerosis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Neuroprotective Agents
- Protective Agents
- Antioxidants
- Anticarcinogenic Agents
- Antimutagenic Agents
- Epigallocatechin gallate
Other Study ID Numbers
- SUPREMES-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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