Multiple SclerosisPhase 1NCT00836719
Safety of Polyphenon E in Multiple Sclerosis Pilot Study
A Phase 1 study testing Polyphenon E in people with Multiple Sclerosis, run by Louisiana State University Health Sciences Center in New Orleans at 1 site in United States.
Trial summary
This study is an open label 6 month study. All subjects will be treated with Polyphenon E (400 mg EGCG twice a day) for six months. The main outcome of this pilot phase will be safety. Secondary outcomes are the change in NAA levels over 6 months as measured by MR-spectroscopy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Polyphenon E
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Nov 2010
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of MS by McDonald criteria
- Relapsing-remitting MS or secondary progressive MS
- Stable therapy with Copaxone, for at least six months prior to inclusion in the study or no therapy for six months in subjects refusing therapy.
- EDSS Score less than or equal to 6.5 (able to walk about 20 meters without resting)
- Ages 18-60.
- Leukocytes ≥3,000/µL
Show all 14Show fewer
- Absolute neutrophil count ≥1,500/µL
- Platelets ≥100,000/µL
- Total bilirubin ≤local upper limit of normal
- normal AST (SGOT) ALT (SGPT)
- normal serum Creatinine
- women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.
- Ability to understand and the willingness to sign a written informed consent document.
- Willing to drink at most one cup of black tea and two cups of coffee per day, and abstain from drinking green tea or taking supplements containing green tea or green tea compounds, for the duration of the investigation.
Who cannot join
- MS relapse within the 30 days prior to enrollment.
- A primary progressive form of MS.
- Previous treatment prior to study entry as follows: complete radiation ablation of the bone marrow or anti-CD4 antibody treatment (Campath) at any time; mitoxantrone, cyclophosphamide, cyclosporin, Natalizumab or other immunomodulatory or immunosuppressant therapies except for Copaxone or methylprednisone for relapses within prior nine months.
- History of renal or liver disease.
- Consumption of green tea or supplements containing green tea or tea extract within 30 days prior to enrollment.
- Participants may not participate in any other clinical trial involving investigational agents during the study, or within six months prior to enrolling in the study.
Show all 12Show fewer
- history of allergic reactions attributed to compounds of similar chemical or biologic composition to Polyphenon E, tea, or any of the inactive ingredients present in the active or placebo capsules, including gelatin.
- history of allergic reactions to gadolinium or any other condition contraindicated for MRI.
- Uncontrolled, clinically-relevant active illness (aside from MS) including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Any condition which would make the subject, in the opinion of the investigator, unsuitable for the study.
- Inability to complete the baseline MRI scan.
- Pregnant or breastfeeding women.
Trial locations and contacts
1 site in 1 country.
United States1 site
Louisiana Health Sciences Center New Orleans
New Orleans, Louisiana, 70112
About this study
Official title: Safety and Neuroprotective Effects of Polyphenon E in Multiple Sclerosis
This study is an open label 6 month study. All subjects will be treated with Polyphenon E (400 mg EGCG twice a day) for six months. The main outcome of this pilot phase will be safety. Secondary outcomes are the change in NAA levels over 6 months as measured by MR-spectroscopy. NAA levels are a marker of neuronal function. We think that Polyphenon E will protect neurons and thus increase NAA levels.
Read the detailed description
Additional clinical data include changes in EDSS, MS functional composite and cognitive testing.
- Conditions
- Multiple Sclerosis
- Being tested
- Polyphenon E
- Keywords
- Multiple sclerosis, safety, open label, Polyphenon E, EGCG, NAA, N-acetyl-aspartate, MRI
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyphenon EDrug
Also called EGCG, Green tea extract
Polyphenon E capsules containing 200 mg of Epigallocachin-galleate. Two capsules twice a day.
| Study group | Role | What they receive |
|---|---|---|
| Polyphenon E | Experimental | Standarized green tea extract containing 50% EGCG Receives: Drug: Polyphenon E |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Experiencing Serious Adverse Events
Measured: six months
Secondary outcomes (1)
Change in Brain NAA Level as Measured by MR Spectroscopy
percent change from baseline to exit in NAA levels adjusted for creatine levels
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Louisiana State University Health Sciences Center in New Orleans
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Jesus Lovera MD, Louisiana State University Health Sciences Center in New Orleans
- Investigators
- Jesus F Lovera, MD, MSPH, Principal investigator, LSUHSC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00836719
- Sponsor's protocol ID
- K23AT004433-01
- Other IDs
- K23AT004433-01, 1K23AT004433-01
- Status last verified
- May 2013
- First submitted
- 3 Feb 2009
- Last updated
- 27 Jun 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Aktas O, Prozorovski T, Smorodchenko A, Savaskan NE, Lauster R, Kloetzel PM, Infante-Duarte C, Brocke S, Zipp F. Green tea epigallocatechin-3-gallate mediates T cellular NF-kappa B inhibition and exerts neuroprotection in autoimmune encephalomyelitis. J Immunol. 2004 Nov 1;173(9):5794-800. doi: 10.4049/jimmunol.173.9.5794.
PubMed 15494532Lovera J, Ramos A, Devier D, Garrison V, Kovner B, Reza T, Koop D, Rooney W, Foundas A, Bourdette D. Polyphenon E, non-futile at neuroprotection in multiple sclerosis but unpredictably hepatotoxic: Phase I single group and phase II randomized placebo-controlled studies. J Neurol Sci. 2015 Nov 15;358(1-2):46-52. doi: 10.1016/j.jns.2015.08.006. Epub 2015 Aug 7.
PubMed 26298797
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Neuroprotective Effects of Polyphenon E in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT00836719
- Acronym / sponsor ID
- K23AT004433-01
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple sclerosis, safety, open label, Polyphenon E, EGCG, NAA, N-acetyl-aspartate, MRI
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Louisiana State University Health Sciences Center in New OrleansUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Feb 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 4 Feb 2009 (estimated)
- Results
- Posted 27 Jun 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is an open label 6 month study. All subjects will be treated with Polyphenon E (400 mg EGCG twice a day) for six months. The main outcome of this pilot phase will be safety. Secondary outcomes are the change in NAA levels over 6 months as measured by MR-spectroscopy. NAA levels are a marker of neuronal function. We think that Polyphenon E will protect neurons and thus increase NAA levels.
Detailed description
Additional clinical data include changes in EDSS, MS functional composite and cognitive testing.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Polyphenon E | Experimental | Drug: Polyphenon EStandarized green tea extract containing 50% EGCG |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Diagnosis of MS by McDonald criteria
- Relapsing-remitting MS or secondary progressive MS
- Stable therapy with Copaxone, for at least six months prior to inclusion in the study or no therapy for six months in subjects refusing therapy.
- EDSS Score less than or equal to 6.5 (able to walk about 20 meters without resting)
- Ages 18-60.
Key exclusion criteria (12 listed)
- MS relapse within the 30 days prior to enrollment.
- A primary progressive form of MS.
- Previous treatment prior to study entry as follows: complete radiation ablation of the bone marrow or anti-CD4 antibody treatment (Campath) at any time; mitoxantrone, cyclophosphamide, cyclosporin, Natalizumab or other immunomodulatory or immunosuppressant therapies except for Copaxone or methylprednisone for relapses within prior nine months.
- History of renal or liver disease.
- Consumption of green tea or supplements containing green tea or tea extract within 30 days prior to enrollment.
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 |
|---|---|---|
| Polyphenon EAlso: EGCG, Green tea extractPolyphenon E capsules containing 200 mg of Epigallocachin-galleate. Two capsules twice a day. | Drug | Polyphenon E |
Primary outcome
Number of Participants Experiencing Serious Adverse Events
Time frame: six months
1 secondary outcome
Change in Brain NAA Level as Measured by MR Spectroscopy
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 15494532Aktas O, Prozorovski T, Smorodchenko A, Savaskan NE, Lauster R, Kloetzel PM, Infante-Duarte C, Brocke S, Zipp F. Green tea epigallocatechin-3-gallate mediates T cellular NF-kappa B inhibition and exerts neuroprotection in autoimmune encephalomyelitis. J Immunol. 2004 Nov 1;173(9):5794-800. doi: 10.4049/jimmunol.173.9.5794.
- Derived from this study: PubMed 26298797Lovera J, Ramos A, Devier D, Garrison V, Kovner B, Reza T, Koop D, Rooney W, Foundas A, Bourdette D. Polyphenon E, non-futile at neuroprotection in multiple sclerosis but unpredictably hepatotoxic: Phase I single group and phase II randomized placebo-controlled studies. J Neurol Sci. 2015 Nov 15;358(1-2):46-52. doi: 10.1016/j.jns.2015.08.006. Epub 2015 Aug 7.
Related trials for Multiple Sclerosis
Recruiting
Dry Needling in Multiple Sclerosis
Multiple Sclerosis
RecruitingObservational study
Study of the Disease Process of Lymphangioleiomyomatosis
Lung Disease, Pneumothorax
RecruitingPhase 2
A Study to Evaluate Pharmacokinetics (PK) and Safety of Subcutaneous (SC) Ublituximab Administered at Various Injection Sites and Relative Bioavailability Via Autoinjector (AI) Versus Syringe Subcutaneously in Participants With Multiple Sclerosis (MS)
Multiple Sclerosis
Active, not recruitingPhase 2
Stopping TSC Onset and Progression 2B: Sirolimus TSC Epilepsy Prevention Study
Tuberous Sclerosis Complex, Epilepsy
RecruitingObservational study
Natural History Study of Progressive Multifocal Leukoencephalopathy (PML)
Progressive Multifocal Leukoencephalopathy
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.
Jesus F Lovera, MD, MSPH principal investigator
LSUHSC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Polyphenon E in people with Multiple Sclerosis, run by Louisiana State University Health Sciences Center in New Orleans at 1 site in United States.
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 14 inclusion and 12 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 27 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jun 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Participants Experiencing Serious Adverse Events (time frame: six 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 NCT00836719, which also lists 2 linked publications.
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 27 Jun 2013.