Sunphenon in Progressive Forms of Multiple Sclerosis (SUPREMES)

• ClinicalTrials.gov Identifier: NCT00799890
• Recruitment Status: Completed
• First Posted: December 1, 2008
• Last Update Posted: July 29, 2021
• Sponsor: Friedemann Paul
• Collaborator: TAIYO EUROPE
• Information provided by (Responsible Party): Friedemann Paul, Charite University, Berlin, Germany

Tracking Information

• First Submitted Date: November 28, 2008
• First Posted Date: December 1, 2008
• Last Update Posted Date: July 29, 2021
• Study Start Date: May 2009
• Actual Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: September 22, 2014): brain atrophy [ Time Frame: 36 months of treatment ]
• Original Primary Outcome Measures (submitted: November 28, 2008): brain atrophy [ Time Frame: after 30 months of treatment ]

Current Secondary Outcome Measures (submitted: September 22, 2014)

• new T2 lesions [ Time Frame: 36 months of treatment ]
• reduction of the NAA/Cr-ratio in MR-spectroscopy [ Time Frame: 36 months of treatment ]
• progression of disability such as cognitive disorders [ Time Frame: 36 months of treatment ]
• number of AEs [ Time Frame: 36 months of treatment ]

Original Secondary Outcome Measures (submitted: November 28, 2008)

• new T2 lesions [ Time Frame: after 30 months of treatment ]
• redution of the NAA/Cr-ratio in MR-spectroscopy [ Time Frame: after 30 months of treatment ]
• progression of disability such as cognitive disorders [ Time Frame: after 30 months of treatment ]
• safety and tolerability of verum treatment [ Time Frame: at every visit and inbetween ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Sunphenon in Progressive Forms of Multiple Sclerosis
• Official Title: Monocentric, Prospective, Doubleblind, Randomised/Stratified, Placebocontrolled Two-arm Study to Evaluate the Effect of Sunphenon EGCg (Main Component Epigallocatechin-Gallat) on the Increase of Brain Atrophy in the Cerebral Magnetic Resonance Tomography in a 36-months Treatment Time in Patients With Primary or Secondary Chronic-progressive Multiple Sclerosis
• 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.

Detailed Description

The hypotheses of our study are:

Sunphenon EGCg has an antiinflammatoric effect due to its impact on the T-cell-proliferation and the inhibition of the activity of NF-Kb.

Sunphenon EGCg has a neuroprotective effect due to its antioxidative potence as a radical scavenger.

A 30 month treatment with Sunphenon EGCg is safe and well-tolerated.

• Study Type: Interventional
• Study Phase: Phase 2; Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Multiple Sclerosis

Intervention

• Drug: Sunphenon EGCG
  200-800mg (1-4 capsules)
  Other Name: Epigallo Catechin Gallate
• Drug: Placebo
  1-4 capsules

Study Arms

• Experimental: Sunphenon
  Intervention: Drug: Sunphenon EGCG
• Placebo Comparator: Placebo
  Intervention: Drug: Placebo

Publications *

• 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 14, 2020): 61
• Original Estimated Enrollment (submitted: November 28, 2008): 60
• Actual Study Completion Date: March 2016
• Actual Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Germany

Administrative Information

• NCT Number: NCT00799890
• Other Study ID Numbers: SUPREMES-01
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Friedemann Paul, Charite University, Berlin, Germany
• Original Responsible Party: Prof. Dr. Frauke Zipp, Charite University Berlin
• Current Study Sponsor: Friedemann Paul
• Original Study Sponsor: Charite University, Berlin, Germany
• Collaborators: TAIYO EUROPE

Investigators

• Principal Investigator: Friedemann Paul, Dr.; Charite University (NeuroCure Clinical Research Center)

• PRS Account: Charite University, Berlin, Germany
• Verification Date: July 2021