Multiple SclerosisPhase 2POEMSNCT01451723
Safety and Neuroprotective Effects of Polyphenon E in MS; Phase II
A Phase 2 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
The hypothesis is that Polyphenon E can protect brain cells in patients with Multiple Sclerosis. To test this hypothesis we are going to compare the changes in n-Acetyl-Aspartate (a chemical that reflects the number of neurons and their metabolism) over one year between people with MS treated with Polyphenon E at a… Read more about this study
- Who is it for?
- Ages 18 to 60 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?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Feb 2013
- Phase
- Phase 2
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of MS by McDonald criteria
- Relapsing-remitting MS or secondary progressive MS
- Stable therapy with Copaxone, Rebif, Betaseron or Avonex 30 mcg for at least six months
- EDSS Score less than or equal to 7.0
- Ages 18-60.
- Participants must have normal organ and marrow function as defined below:
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- Leukocytes ≥3,000/µL
- Absolute neutrophil count ≥1,500/µL
- Platelets ≥100,000/µL
- Total bilirubin ≤local upper limit of normal
- AST (SGOT) ≤local upper limit of normal
- ALT (SGPT) ≤local upper limit of normal
- Creatinine ≤local upper limit of normal
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, Natalizumab or other immunomodulatory or immunosuppressant therapies except the DMT's included in the inclusion criteria and 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.
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- 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 women
- Any underlying predisposition to gastrointestinal bleeding (peptic ulcer disease, gastritis, diverticulitis, colitis, hemorrhoids)
Trial locations and contacts
1 site in 1 country.
United States1 site
LSu Health Sciences Center
New Orleans, Louisiana, 70112
About this study
Official title: Phase 2 Randomized Placebo Controlled Trial of Polyphenon E in MS
The hypothesis is that Polyphenon E can protect brain cells in patients with Multiple Sclerosis. To test this hypothesis we are going to compare the changes in n-Acetyl-Aspartate (a chemical that reflects the number of neurons and their metabolism) over one year between people with MS treated with Polyphenon E at a dose of 400mg twice a day and people with MS treated with a matching sugar pill.
Read the detailed description
This will be a double blind placebo controlled trial of Polyphenon E as a treatment for MS.
The primary outcome will be the changes in NAA levels over one year. Secondary outcomes will be changes in brain atrophy over one year. As an exploratory outcome we will correlate changes in NAA levels with free Plasma levels of EGCG 8 hours after the morning dose.
Exploratory outcomes include disability progression by EDSS, MS functional composite components and a cognitive test battery.
- Conditions
- Multiple Sclerosis
- Being tested
- Polyphenon E, Placebo
- Keywords
- Multiple Sclerosis, Polyphenon E, Green tea, EGCG, Epigallocatechin-galleate, Placebo, Randomized controlled trial
- 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, epigallocatechin gallate, Green tea extract
Polyphenon E is a standardized green tea extract. For this study we will use capsules of Polyphenon E containing 200 mg of EGCG per capsule. Subjects will take two capsules twice a day with food.
PlaceboOther
Matching placebo capsules
| Study group | Role | What they receive |
|---|---|---|
| Polyphenon E 400mg twice a day | Experimental | Two capsules of Polyphenon E containing 200mg of EGCG each taken twice a day with food. Receives: Drug: Polyphenon E |
| Placebo | Placebo comparator | Matching placebo capsules. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Change in NAA Levels Adjusted for Water Content.
The rate of change will be calculated using all the time points available )baseline, 6 and 12 months) using a mixed model analysis with the Log NAA as the dependent variable and water content, %grey matter, %white matter, %CSF and % lesion volume as covariates. All the voxels available for each subject where estimates have a SD <30 will be used. A spatial anysotropic exponential covariance structure will be used.
Measured: 1 year
Secondary outcomes (1)
Brain Atrophy
Difference between the two groups in brain atrophy as measured by SIENA
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2011 (estimated)
- Study startJul 2011
- Primary completionFeb 2013
- Study completionFeb 2013
Why it stopped: Unusual high frequency of elevated liver function tests.
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 (1)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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 11 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, Principal investigator, LSUHSC-New Orleans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01451723
- Sponsor's protocol ID
- K23AT004433-02
- Other IDs
- K23AT004433-02, K23AT004433
- Acronym
- POEMS
- Status last verified
- Jan 2014
- First submitted
- 11 Oct 2011
- Last updated
- 14 Mar 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Lovera 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 14 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Randomized Placebo Controlled Trial of Polyphenon E in MS
- ClinicalTrials.gov ID
- NCT01451723
- Acronym / sponsor ID
- POEMS / K23AT004433-02
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Polyphenon E, Green tea, EGCG, Epigallocatechin-galleate, Placebo, Randomized controlled trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unusual high frequency of elevated liver function tests.
- Enrolment
- 11 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
- Jul 2011
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 14 Oct 2011 (estimated)
- Results
- Posted 14 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The hypothesis is that Polyphenon E can protect brain cells in patients with Multiple Sclerosis. To test this hypothesis we are going to compare the changes in n-Acetyl-Aspartate (a chemical that reflects the number of neurons and their metabolism) over one year between people with MS treated with Polyphenon E at a dose of 400mg twice a day and people with MS treated with a matching sugar pill.
Detailed description
This will be a double blind placebo controlled trial of Polyphenon E as a treatment for MS.
The primary outcome will be the changes in NAA levels over one year. Secondary outcomes will be changes in brain atrophy over one year. As an exploratory outcome we will correlate changes in NAA levels with free Plasma levels of EGCG 8 hours after the morning dose.
Exploratory outcomes include disability progression by EDSS, MS functional composite components and a cognitive test battery.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Polyphenon E 400mg twice a day | Experimental | Drug: Polyphenon ETwo capsules of Polyphenon E containing 200mg of EGCG each taken twice a day with food. |
| Placebo | Placebo comparator | Other: PlaceboMatching placebo capsules. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Diagnosis of MS by McDonald criteria
- Relapsing-remitting MS or secondary progressive MS
- Stable therapy with Copaxone, Rebif, Betaseron or Avonex 30 mcg for at least six months
- EDSS Score less than or equal to 7.0
- Ages 18-60.
Key exclusion criteria (13 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, Natalizumab or other immunomodulatory or immunosuppressant therapies except the DMT's included in the inclusion criteria and 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, epigallocatechin gallate, Green tea extractPolyphenon E is a standardized green tea extract. For this study we will use capsules of Polyphenon E containing 200 mg of EGCG per capsule. Subjects will take two capsules twice a day with food. | Drug | Polyphenon E 400mg twice a day |
| PlaceboMatching placebo capsules | Other | Placebo |
Primary outcome
Rate of Change in NAA Levels Adjusted for Water Content.
Time frame: 1 year
The rate of change will be calculated using all the time points available )baseline, 6 and 12 months) using a mixed model analysis with the Log NAA as the dependent variable and water content, %grey matter, %white matter, %CSF and % lesion volume as covariates. All the voxels available for each subject where estimates have a SD <30 will be used. A spatial anysotropic exponential covariance structure will be used.
1 secondary outcome
Brain Atrophy
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
- LSU MS ClinicLink 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.
Jesus F Lovera, MD principal investigator
LSUHSC-New Orleans
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 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 13 inclusion and 13 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: stopped early, as of the sponsor's last update on 14 Mar 2014. 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. Some participants in this study may receive a placebo. 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 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?
Yes. Results are posted in the registry (first posted 14 Mar 2014). 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?
Rate of Change in NAA Levels Adjusted for Water Content. (time frame: 1 year). 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 NCT01451723, 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 14 Mar 2014.