Sunphenon in Progressive Forms of Multiple Sclerosis

Multiple Sclerosis Clinical Trial

— SUPREMES  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00799890
• Other study ID #: SUPREMES-01
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: May 2009
• Est. completion date: March 2016

Study information

• Verified date: July 2021
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Sunphenon EGCG
200-800mg (1-4 capsules)
• Placebo
1-4 capsules

Locations

Country	Name	City	State
Germany	Charité Universitätsmedizin Berlin (NeuroCure Clinical Research Center)	Berlin

Sponsors (2)

Lead Sponsor	Collaborator
Friedemann Paul	TAIYO EUROPE

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	brain atrophy		36 months of treatment
Secondary	new T2 lesions		36 months of treatment
Secondary	reduction of the NAA/Cr-ratio in MR-spectroscopy		36 months of treatment
Secondary	progression of disability such as cognitive disorders		36 months of treatment
Secondary	number of AEs		36 months of treatment

External Links

•   Related Info
•   Related Info