Clinical trial NCT00799890: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Multiple Sclerosis
Keywords: primary or secondary chronic-progressive
sunphenon egcg
brain atrophy
T2 lesions
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: TAIYO EUROPE
First posted: 2008-12-01
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: brain atrophy
timeFrame: 36 months of treatment
Secondary outcomes:
measure: new T2 lesions
timeFrame: 36 months of treatment
measure: reduction of the NAA/Cr-ratio in MR-spectroscopy
timeFrame: 36 months of treatment
measure: progression of disability such as cognitive disorders
timeFrame: 36 months of treatment
measure: number of AEs
timeFrame: 36 months of treatment
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin (NeuroCure Clinical Research Center)
Study officials:
affiliation: Charite University (NeuroCure Clinical Research Center)
name: Friedemann Paul, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.