Relapsing-remitting Multiple SclerosisPhase 1/2SuniMSNCT00525668
Sunphenon Epigallocatechin-gallate (EGCg) in Relapsing-remitting Multiple Sclerosis (SuniMS Study)
A Phase 1/2 study testing epigallocatechin-gallate (Sunphenon) in people with Relapsing-remitting Multiple Sclerosis, run by Charite University, Berlin, Germany at 2 sites in Germany.
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). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Relapsing-remitting Multiple Sclerosis
- What is being tested?
- epigallocatechin-gallate (Sunphenon)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 2 sitesGermany
- Study dates
- Sep 2007to Nov 2012
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- primary or secondary progressive forms of MS
- clinically relevant heart, lung, liver, kidney diseases
- regular hepatotoxic co-medication
- drug addiction
- alcohol abuse
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
NeuroCure Clinical Research Center, Charite University, Berlin
Berlin, 10117
Outpatient Clinic for Neuroimmunology at the ECRC, Charite University, Berlin
Berlin, 13125
About this study
Official title: Sunphenon EGCg (Epigallocatechin-gallate) in Relapsing-remitting Multiple Sclerosis (SuniMS Study)
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).
Read the detailed description
This multicentric, national study investigates the efficacy and safety of EGCG in patients with relapsing-remitting multiple sclerosis.
- Conditions
- Relapsing-remitting Multiple Sclerosis
- Being tested
- epigallocatechin-gallate (Sunphenon), placebo
- Keywords
- multiple sclerosis, inflammation, neurodegeneration, neuroprotection
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis, Inflammation, Nerve Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
epigallocatechin-gallate (Sunphenon)Drug
200 mg twice daily, after 3 months 400 mg twice daily
placeboDrug
2 placebo capsules twice daily, after 3 months 4 placebo capsules twice daily
| Study group | Role | What they receive |
|---|---|---|
| verum | Active comparator | Sunphenon plus glatiramer acetate Receives: Drug: epigallocatechin-gallate (Sunphenon) |
| placebo | Active comparator | placebo plus glatiramer acetate Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 18 months
Secondary outcomes (2)
development of brain atrophy under treatment with EGCG vs. placebo
Measured: 18 months
Safety and tolerability
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2007 (estimated)
- Study startSep 2007
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Relapsing-remitting Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Friedemann Paul, Charite University, Berlin, Germany
- Investigators
- Judith Bellmann-Strobl, Dr., MD, Principal investigator, Experimental and Clinical Research Center, Charite University, Berlin, GermanyFriedemann Paul, Prof., MD, Study director, NeuroCure Clinical Research Center, Charité University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00525668
- Sponsor's protocol ID
- 2006-006323-39
- Acronym
- SuniMS
- Status last verified
- Jul 2021
- First submitted
- 4 Sep 2007
- Last updated
- 29 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bellmann-Strobl J, Paul F, Wuerfel J, Dorr J, Infante-Duarte C, Heidrich E, Kortgen B, Brandt A, Pfuller C, Radbruch H, Rust R, Siffrin V, Aktas O, Heesen C, Faiss J, Hoffmann F, Lorenz M, Zimmermann B, Groppa S, Wernecke KD, Zipp F. Epigallocatechin Gallate in Relapsing-Remitting Multiple Sclerosis: A Randomized, Placebo-Controlled Trial. Neurol Neuroimmunol Neuroinflamm. 2021 Mar 24;8(3):e981. doi: 10.1212/NXI.0000000000000981. Print 2021 May.
PubMed 33762428
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sunphenon EGCg (Epigallocatechin-gallate) in Relapsing-remitting Multiple Sclerosis (SuniMS Study)
- ClinicalTrials.gov ID
- NCT00525668
- Acronym / sponsor ID
- SuniMS / 2006-006323-39
- Conditions
- Relapsing-remitting Multiple Sclerosis
- Keywords
- multiple sclerosis, inflammation, neurodegeneration, neuroprotection
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 6 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
This multicentric, national study investigates the efficacy and safety of EGCG in patients with relapsing-remitting multiple sclerosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| verum | Active comparator | Drug: epigallocatechin-gallate (Sunphenon)Sunphenon plus glatiramer acetate |
| placebo | Active comparator | Drug: placeboplacebo plus glatiramer acetate |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- primary or secondary progressive forms of MS
- clinically relevant heart, lung, liver, kidney diseases
- regular hepatotoxic co-medication
- drug addiction
- alcohol abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| epigallocatechin-gallate (Sunphenon)200 mg twice daily, after 3 months 400 mg twice daily | Drug | verum |
| placebo2 placebo capsules twice daily, after 3 months 4 placebo capsules twice daily | Drug | placebo |
Primary outcome
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
2 secondary outcomes
development of brain atrophy under treatment with EGCG vs. placebo
Time frame: 18 months
Safety and tolerability
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2021.
- Derived from this study: PubMed 33762428Bellmann-Strobl J, Paul F, Wuerfel J, Dorr J, Infante-Duarte C, Heidrich E, Kortgen B, Brandt A, Pfuller C, Radbruch H, Rust R, Siffrin V, Aktas O, Heesen C, Faiss J, Hoffmann F, Lorenz M, Zimmermann B, Groppa S, Wernecke KD, Zipp F. Epigallocatechin Gallate in Relapsing-Remitting Multiple Sclerosis: A Randomized, Placebo-Controlled Trial. Neurol Neuroimmunol Neuroinflamm. 2021 Mar 24;8(3):e981. doi: 10.1212/NXI.0000000000000981. Print 2021 May.
- Homepage of the Outpatient Clinic for NeuroimmunologyLink provided by the sponsor.
- Homepage of the NeuroCure Clinical Research CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Judith Bellmann-Strobl, Dr., MD principal investigator
Experimental and Clinical Research Center, Charite University, Berlin, Germany
Friedemann Paul, Prof., MD study director
NeuroCure Clinical Research Center, Charité University, Berlin, Germany
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing epigallocatechin-gallate (Sunphenon) in people with Relapsing-remitting Multiple Sclerosis, run by Charite University, Berlin, Germany at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00525668, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2021.