Safety of Polyphenon E in Multiple Sclerosis Pilot Study
This study has been completed.
Information provided by (Responsible Party):
Jesus Lovera MD, Louisiana State University Health Sciences Center in New Orleans
First received: February 3, 2009
Last updated: May 21, 2013
Last verified: May 2013
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
||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Safety and Neuroprotective Effects of Polyphenon E in Multiple Sclerosis
Primary Outcome Measures:
- Number of Participants Experiencing Serious Adverse Events [ Time Frame: six months ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||November 2010 (Final data collection date for primary outcome measure)
Experimental: Polyphenon E
Standarized green tea extract containing 50% EGCG
Drug: Polyphenon E
Polyphenon E capsules containing 200 mg of Epigallocachin-galleate. Two capsules twice a day.
Additional clinical data include changes in EDSS, MS functional composite and cognitive testing.
|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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00836719
|Louisiana Health Sciences Center New Orleans
|New Orleans, Louisiana, United States, 70112 |
Louisiana State University Health Sciences Center in New Orleans
||Jesus F Lovera, MD, MSPH
||Jesus Lovera MD, Assistant Profesor, Louisiana State University Health Sciences Center in New Orleans
History of Changes
|Other Study ID Numbers:
||K23 AT004433-01, K23AT004433-01, 1K23AT004433-01
|Study First Received:
||February 3, 2009
|Results First Received:
||April 4, 2013
||May 21, 2013
||United States: Food and Drug Administration
Keywords provided by Louisiana State University Health Sciences Center in New Orleans:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 31, 2014
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Immune System Diseases