Safety and Neuroprotective Effects of Polyphenon E in MS; Phase II

Multiple Sclerosis Clinical Trial

— POEMS  

Official title:

Phase 2 Randomized Placebo Controlled Trial of Polyphenon E in MS

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01451723
• Other study ID #: K23AT004433-02
• Secondary ID: K23AT004433-02K2
• Status: Terminated
• Phase: Phase 2
• First received: October 11, 2011
• Last updated: January 30, 2014
• Start date: July 2011
• Est. completion date: February 2013

Study information

• Verified date: January 2014
• Source: Louisiana State University Health Sciences Center in New Orleans
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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 dose of 400mg twice a day and people with MS treated with a matching sugar pill.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• 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:

1. Leukocytes =3,000/µL

2. Absolute neutrophil count =1,500/µL

3. Platelets =100,000/µL

4. Total bilirubin =local upper limit of normal

5. AST (SGOT) =local upper limit of normal

6. ALT (SGPT) =local upper limit of normal

7. Creatinine =local upper limit of normal

Exclusion Criteria:

• 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.

• 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)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis

Intervention

Drug:
• Polyphenon E
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.

Other:
• Placebo
Matching placebo capsules

Locations

Country	Name	City	State
United States	LSu Health Sciences Center	New Orleans	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
Louisiana State University Health Sciences Center in New Orleans	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year	No
Secondary	Brain Atrophy	Difference between the two groups in brain atrophy as measured by SIENA	1 year	No

External Links

•   LSU MS Clinic