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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 3 October 2016
Main ID:  NCT02011451
Date of registration: 10/12/2013
Prospective Registration: Yes
Primary sponsor: Louisiana State University Health Sciences Center in New Orleans
Public title: Safety and Brain Protection Effects of the Green Tea Extract Theaphenon 95% (95% Pure EGCG) in Multiple Sclerosis
Scientific title: Safety and Neuroprotective Effects of Theaphenon 95% (95% Pure EGCG) in Multiple Sclerosis
Date of first enrolment: December 2015
Target sample size: 0
Recruitment status: Withdrawn
URL:  https://clinicaltrials.gov/show/NCT02011451
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment  
Phase:  Phase 2
Countries of recruitment
United States
Contacts
Key inclusion & exclusion criteria

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:

- 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

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)



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Multiple Sclerosis
Intervention(s)
Drug: 95% Pure ECGC capsules 200mg
Drug: Placebo Comparator:
Primary Outcome(s)
Rate of change in NAA levels adjusted for water content. [Time Frame: 6 months]
Secondary Outcome(s)
Brain Atrophy [Time Frame: 6 months]
Secondary ID(s)
4818-A-1
4816-A-1
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
National Multiple Sclerosis Society
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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