NCT00799890

Brief Summary

The investigators hypothesize that an oral Sunphenon EGCg (Epigallocatechin-Gallat, EGCG) treatment is - due to its antiinflamatoric and neuroprotective potence - significantly more effective than an oral placebo treatment regarding following parameters: increase in brain atrophy, number of new T2-lesions in the cerebral magnetic resonance tomography, reduction of the NAA/Cr-ratio in MR-spectroscopy, progression of disability such as cognitive disorders in patients with MS.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P50-P75 for phase_2 multiple-sclerosis

Timeline
Completed

Started May 2009

Longer than P75 for phase_2 multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 28, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 1, 2008

Completed
5 months until next milestone

Study Start

First participant enrolled

May 1, 2009

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

July 29, 2021

Status Verified

July 1, 2021

Enrollment Period

6.8 years

First QC Date

November 28, 2008

Last Update Submit

July 28, 2021

Conditions

Multiple Sclerosis

Keywords

primary or secondary chronic-progressivesunphenon egcgbrain atrophyT2 lesions

Outcome Measures

Primary Outcomes (1)

  • brain atrophy

    36 months of treatment

Secondary Outcomes (4)

  • new T2 lesions

    36 months of treatment

  • reduction of the NAA/Cr-ratio in MR-spectroscopy

    36 months of treatment

  • progression of disability such as cognitive disorders

    36 months of treatment

  • number of AEs

    36 months of treatment

Study Arms (2)

Sunphenon

EXPERIMENTAL
Drug: Sunphenon EGCG

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

Sunphenon EGCGDRUG

200-800mg (1-4 capsules)

Also known as: Epigallo Catechin Gallate
Sunphenon
PlaceboDRUG

1-4 capsules

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary or secondary chronic progressive multiple sclerosis (ms)
  • EDSS 3-8
  • Age 18-65

You may not qualify if:

  • Relapsing-remitting ms
  • Immunodulatoric or immunosuppressive therapy
  • pretreatment with Mitoxantron, Natalizumab, Rituximab, Azathioprin \<2 month before screening
  • pretreatment with Glairameracetat or beta-Interferons \<4 weeks before screening
  • signs of hepatic dysfunction
  • active ulcus ventriculi or duodeni
  • neoplasias if not cured \>1 year before screening

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité Universitätsmedizin Berlin (NeuroCure Clinical Research Center)

Berlin, 10117, Germany

Location

Related Publications (2)

  • Klumbies K, Rust R, Dorr J, Konietschke F, Paul F, Bellmann-Strobl J, Brandt AU, Zimmermann HG. Retinal Thickness Analysis in Progressive Multiple Sclerosis Patients Treated With Epigallocatechin Gallate: Optical Coherence Tomography Results From the SUPREMES Study. Front Neurol. 2021 Apr 28;12:615790. doi: 10.3389/fneur.2021.615790. eCollection 2021.

    PMID: 33995239DERIVED

  • Rust R, Chien C, Scheel M, Brandt AU, Dorr J, Wuerfel J, Klumbies K, Zimmermann H, Lorenz M, Wernecke KD, Bellmann-Strobl J, Paul F. Epigallocatechin Gallate in Progressive MS: A Randomized, Placebo-Controlled Trial. Neurol Neuroimmunol Neuroinflamm. 2021 Feb 23;8(3):e964. doi: 10.1212/NXI.0000000000000964. Print 2021 May.

    PMID: 33622766DERIVED

Related Links

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

epigallocatechin gallate

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Friedemann Paul, Dr.

    Charite University (NeuroCure Clinical Research Center)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

November 28, 2008

First Posted

December 1, 2008

Study Start

May 1, 2009

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

July 29, 2021

Record last verified: 2021-07

Locations

DE(1)