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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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4 March 2013 |
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Main ID: |
NCT00525668 |
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Date of registration:
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04/09/2007 |
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Primary sponsor: |
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Public title:
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Sunphenon Epigallocatechin-gallate (EGCg) in Relapsing-remitting Multiple Sclerosis (SuniMS Study)
SuniMS |
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Scientific title:
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Sunphenon EGCg (Epigallocatechin-gallate) in Relapsing-remitting Multiple Sclerosis (SuniMS Study) |
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Date of first enrolment:
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September 2007 |
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Target sample size:
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120 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00525668 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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Germany
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Contacts
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Name:
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Judith Bellmann-Strobl, Dr., MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Experimental and Clinical Research Center, Charite University, Berlin, Germany |
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Name:
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Friedemann Paul, Prof. , MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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NeuroCure Clinical Research Center, Charité University, Berlin, Germany |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Relapsing-remitting Multiple Sclerosis
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Intervention(s)
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Drug: epigallocatechin-gallate (Sunphenon)
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Drug: placebo
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Primary Outcome(s)
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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
[Time Frame: 18 months]
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Secondary Outcome(s)
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development of brain atrophy under treatment with EGCG vs. placebo
[Time Frame: 18 months]
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Safety and tolerability
[Time Frame: 18 months]
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Secondary ID(s)
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2006-006323-39
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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