Multiple SclerosisPhase 2NCT02011451
Safety and Brain Protection Effects of the Green Tea Extract Theaphenon 95% (95% Pure EGCG) in Multiple Sclerosis
A Phase 2 study testing 95% Pure ECGC capsules 200mg 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 95% pure EGCG 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 six between people with MS treated with EGCG at a dose of… 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?
- 95% Pure ECGC capsules 200mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to Dec 2017
- Phase
- Phase 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 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, 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: Safety and Neuroprotective Effects of Theaphenon 95% (95% Pure EGCG) in Multiple Sclerosis
The hypothesis is that 95% pure EGCG 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 six between people with MS treated with EGCG 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 Theaphenon 95% (95% pure Epigallo-catechin-galleate [EGCG]) as a treatment for MS.
The primary outcome will be the changes in N-Acety-Aspartate (NAA) levels over six months. Secondary outcomes will be changes in brain atrophy over over six months. 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 Expanded Disability Status Scale (EDSS), multiple sclerosis functional composite components and a cognitive test battery.
- Conditions
- Multiple Sclerosis
- Being tested
- 95% Pure ECGC capsules 200mg, Placebo Comparator:
- Keywords
- Multiple Sclerosis, Green Tea, ECGC, Theaphenon, Randomized placebo controlled trial, NAA, Spectroscopy, Brain Atrophy, SIENA
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
95% Pure ECGC capsules 200mgDrug
Also called Theaphenon 95%
Theaphenon 95% 95% Pure EGCG
Placebo Comparator:Drug
Also called "Sugar pill"
| Study group | Role | What they receive |
|---|---|---|
| 95% Pure ECGC capsules 200mg | Experimental | 95% Pure ECGC capsules 200mg three times a day with food for 6 months Receives: Drug: 95% Pure ECGC capsules 200mg |
| Sugar pill | Placebo comparator | Matched placebo capsules Receives: Drug: Placebo Comparator: |
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,3 and 6 months) using a mixed model analysis with the Log NAA as the dependent variable and water content, %grey matter, %white matter, %cerebrospinal fluid (CSF) and % lesion volume as covariates. All the voxels available for each subject where estimates have a standard deviation(SD) <30 will be used. A spatial anisotropic exponential covariance structure will be used.
Measured: 6 months
Secondary outcomes (1)
Brain Atrophy
Difference between the two groups in brain atrophy as measured by SIENA
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 posted13 Dec 2013 (estimated)
- Study startDec 2015
- Primary completionMar 2017 (estimated)
- Study completionDec 2017 (estimated)
Why it stopped: unable to enroll
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Louisiana State University Health Sciences Center in New Orleans
- Sponsor type
- University, hospital or other
- Collaborators
- National Multiple Sclerosis Society
- Responsible party
- Principal investigator, Jesus Lovera MD, Louisiana State University Health Sciences Center in New Orleans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02011451
- Sponsor's protocol ID
- 4818-A-1
- Other IDs
- 4816-A-1
- Status last verified
- Sep 2016
- First submitted
- 10 Dec 2013
- Last updated
- 26 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Neuroprotective Effects of Theaphenon 95% (95% Pure EGCG) in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT02011451
- Acronym / sponsor ID
- 4818-A-1
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Green Tea, ECGC, Theaphenon, Randomized placebo controlled trial, NAA, Spectroscopy, Brain Atrophy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: unable to enroll
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Louisiana State University Health Sciences Center in New OrleansUniversity, hospital or other
- Collaborators
- National Multiple Sclerosis Society
- Study start
- Dec 2015
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 13 Dec 2013 (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.
The hypothesis is that 95% pure EGCG 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 six between people with MS treated with EGCG 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 Theaphenon 95% (95% pure Epigallo-catechin-galleate [EGCG]) as a treatment for MS.
The primary outcome will be the changes in N-Acety-Aspartate (NAA) levels over six months. Secondary outcomes will be changes in brain atrophy over over six months. 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 Expanded Disability Status Scale (EDSS), multiple sclerosis functional composite components and a cognitive test battery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 95% Pure ECGC capsules 200mg | Experimental | Drug: 95% Pure ECGC capsules 200mg95% Pure ECGC capsules 200mg three times a day with food for 6 months |
| Sugar pill | Placebo comparator | Drug: Placebo Comparator:Matched placebo capsules |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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 |
|---|---|---|
| 95% Pure ECGC capsules 200mgAlso: Theaphenon 95%Theaphenon 95% 95% Pure EGCG | Drug | 95% Pure ECGC capsules 200mg |
| Placebo Comparator:Also: "Sugar pill" | Drug | Sugar pill |
Primary outcome
Rate of change in NAA levels adjusted for water content.
Time frame: 6 months
The rate of change will be calculated using all the time points available (baseline,3 and 6 months) using a mixed model analysis with the Log NAA as the dependent variable and water content, %grey matter, %white matter, %cerebrospinal fluid (CSF) and % lesion volume as covariates. All the voxels available for each subject where estimates have a standard deviation(SD) <30 will be used. A spatial anisotropic exponential covariance structure will be used.
1 secondary outcome
Brain Atrophy
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 95% Pure ECGC capsules 200mg 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: withdrawn, as of the sponsor's last update on 26 Sep 2016. 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?
The study was withdrawn before enrolling participants, so there are no results.
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: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Sep 2016.