Sunphenon in Progressive Forms of Multiple Sclerosis (SUPREMES)
This study is ongoing, but not recruiting participants.
Sponsor:
Charite University, Berlin, Germany
Collaborator:
TAIYO EUROPE
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00799890
First received: November 28, 2008
Last updated: November 13, 2012
Last verified: November 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Primary or Secondary Chronic-progressive Multiple Sclerosis |
Drug: Sunphenon EGCG Drug: Placebo |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | 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 30-months Treatment Time in Patients With Primary or Secondary Chronic-progressive Multiple Sclerosis |
Resource links provided by NLM:
Genetics Home Reference related topics:
multiple sclerosis
MedlinePlus related topics:
Multiple Sclerosis
U.S. FDA Resources
Further study details as provided by Charite University, Berlin, Germany:
Primary Outcome Measures:
- brain atrophy [ Time Frame: after 30 months of treatment ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- new T2 lesions [ Time Frame: after 30 months of treatment ] [ Designated as safety issue: No ]
- reduction of the NAA/Cr-ratio in MR-spectroscopy [ Time Frame: after 30 months of treatment ] [ Designated as safety issue: No ]
- progression of disability such as cognitive disorders [ Time Frame: after 30 months of treatment ] [ Designated as safety issue: No ]
- safety and tolerability of verum treatment (number of AEs incl. safetylab values) [ Time Frame: assessed at every (unscheduled or scheduled) visit ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 60 |
| Study Start Date: | April 2009 |
| Estimated Study Completion Date: | May 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Sunphenon |
Drug: Sunphenon EGCG
200-800mg (1-4 capsules)
Other Name: Epigallo Catechin Gallate
|
| Placebo Comparator: Placebo |
Drug: Placebo
1-4 capsules
Other Name: n.a.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00799890
Locations
| Germany | |
| Charité Universitätsmedizin Berlin (NeuroCure Clinical Research Center) | |
| Berlin, Germany, 10117 | |
Sponsors and Collaborators
Charite University, Berlin, Germany
TAIYO EUROPE
Investigators
| Principal Investigator: | Friedemann Paul, Dr. | Charite University (NeuroCure Clinical Research Center) |
More Information
Additional Information:
No publications provided
| Responsible Party: | Dr. Friedemann Paul, Charite University Berlin |
| ClinicalTrials.gov Identifier: | NCT00799890 History of Changes |
| Other Study ID Numbers: | SUPREMES-01 |
| Study First Received: | November 28, 2008 |
| Last Updated: | November 13, 2012 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by Charite University, Berlin, Germany:
|
multiple sclerosis sunphenon egcg brain atrophy T2 lesions |
Additional relevant MeSH terms:
|
Multiple Sclerosis Sclerosis Multiple Sclerosis, Chronic Progressive Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases Pathologic Processes Epigallocatechin gallate |
Antioxidants Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protective Agents Physiological Effects of Drugs Antimutagenic Agents Anticarcinogenic Agents Antineoplastic Agents Therapeutic Uses Neuroprotective Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 21, 2013