Safety of Polyphenon E in Multiple Sclerosis Pilot Study
The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by National Center for Complementary and Alternative Medicine (NCCAM).
Recruitment status was Recruiting
Information provided by:
National Center for Complementary and Alternative Medicine (NCCAM)
First received: February 3, 2009
Last updated: August 13, 2009
Last verified: August 2009
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.
Drug: Polyphenon E
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Safety and Neuroprotective Effects of Polyphenon E in Multiple Sclerosis
Primary Outcome Measures:
- Frequency and severity of adverse events [ Time Frame: six months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Change in brain NAA level as measured by MR Spectroscopy [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Change in peak T1 times [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- serum levels of EGCG will be correlated with the changes in NAA and other imaging parameters [ Time Frame: 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||October 2009 (Final data collection date for primary outcome measure)
Experimental: Polyphenon E
Drug: Polyphenon E
Polyphenon E capsules containing 200 mg of Epigallcachin-galleate. Two capsules twice a day.
|Ages Eligible for Study:
||18 Years to 65 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00836719
|Louisiana Health Sciences Center New Orleans
|New Orleans, Louisiana, United States, 70112 |
|Contact: Jesus Lovera, MD 504-903-9302 |
|Principal Investigator: Jesus F Lovera, MD |
|Sub-Investigator: Amparo Gutierrez, MD |
|Sub-Investigator: Bridget Bagert, MD |
||Jesus Lovera MD, Louisiana State University Health Sciences Center New Orleans
History of Changes
|Other Study ID Numbers:
||K23 AT004433-01, 1K23AT004433-01 Pilot
|Study First Received:
||February 3, 2009
||August 13, 2009
||United States: Food and Drug Administration
Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 23, 2013
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Immune System Diseases