Safety and Brain Protection Effects of the Green Tea Extract Theaphenon 95% (95% Pure EGCG) in Multiple Sclerosis

• 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• Recruitment status: Withdrawn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

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: Placebo Comparator:

Drug: 95% Pure ECGC capsules 200mg

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)

4816-A-1

4818-A-1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Multiple Sclerosis Society