Trial record 6 of 55 for:    "Multiple Sclerosis, Chronic Progressive"

Sunphenon in Progressive Forms of Multiple Sclerosis (SUPREMES)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
TAIYO EUROPE
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00799890
First received: November 28, 2008
Last updated: August 7, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention Phase
Primary or Secondary Chronic-progressive Multiple Sclerosis
Drug: Sunphenon EGCG
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • brain atrophy [ Time Frame: after 36 months of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • new T2 lesions [ Time Frame: after 36 months of treatment ] [ Designated as safety issue: No ]
  • reduction of the NAA/Cr-ratio in MR-spectroscopy [ Time Frame: after 36 months of treatment ] [ Designated as safety issue: No ]
  • progression of disability such as cognitive disorders [ Time Frame: after 36 months of treatment ] [ Designated as safety issue: No ]
  • safety and tolerability of verum treatment (number of AEs incl. safetylab values) [ Time Frame: assessed at every (unscheduled or scheduled) visit ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: May 2009
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sunphenon Drug: Sunphenon EGCG
200-800mg (1-4 capsules)
Other Name: Epigallo Catechin Gallate
Placebo Comparator: Placebo Drug: Placebo
1-4 capsules
Other Name: n.a.

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00799890

Locations
Germany
Charité Universitätsmedizin Berlin (NeuroCure Clinical Research Center)
Berlin, Germany, 10117
Sponsors and Collaborators
Charite University, Berlin, Germany
TAIYO EUROPE
Investigators
Principal Investigator: Friedemann Paul, Dr. Charite University (NeuroCure Clinical Research Center)
  More Information

Additional Information:
No publications provided

Responsible Party: Dr. Friedemann Paul, Charite University Berlin
ClinicalTrials.gov Identifier: NCT00799890     History of Changes
Other Study ID Numbers: SUPREMES-01
Study First Received: November 28, 2008
Last Updated: August 7, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Charite University, Berlin, Germany:
multiple sclerosis
sunphenon egcg
brain atrophy
T2 lesions

Additional relevant MeSH terms:
Multiple Sclerosis, Chronic Progressive
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Epigallocatechin gallate
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Antimutagenic Agents
Anticarcinogenic Agents
Antineoplastic Agents
Therapeutic Uses
Neuroprotective Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 27, 2014