SUPREMES - Sunphenon in progressive forms of multiple sclerosis

Phase 1

• Conditions: primary and secondary progressive forms of multiple sclerosis; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2008-005213-22-DE
• Lead Sponsor: Charite Universitätsmedizin Berlin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-08-22
• Last Update Posted: 18 March 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

age 18-65, primary or secondary progressive Multiple Sclerosis according to McDonald-criteria, EDSS 3-8, negative pregnancy test, use of highly effective methods of birth control in women with childbearing potential, informed consent, max. 4 cups of coffee and 2 cups of black tea daily, no consumption of grean tea or larger amounts of grapefruit juice, at least 30 days between the last relapse and screening

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 52
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8

Exclusion Criteria

relapsing remitting Multiple Sclerosis, clinical or laboratory findings of impaired liver function, psychiatric disorders, concomitant medication of hepatotoxic medication, any other relevant disorder

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate efficacy and safety of Sunphenon EGCg in progressive forms of multiple sclerosis after a 36 months treatment compared to the placebo-group, primary outcome criteria being reduction of Brain Parenchymal Fraction (atrophy) ;Secondary Objective: - T2-lesions (number and volume)<br>- T1 hypointensive lesions („black holes)<br>- changes in the NAA/Cr ratio (spectroscopy)<br>- EDSS<br>- cognitive functions and fatigue <br>- RNFL („retinal nerve fiber layer) thickness (optic coherencetomography)<br><br>;Primary end point(s): Brain Parenchymal Fraction / atrophy after 36 months of treatment vs. placebo;Timepoint(s) of evaluation of this end point: month 0-36<br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): T2 leasion, T1 hypotensive leasion, EDSS, changes in NAA/Cr quotient in spectroscopy, cognitive disorders and fatigue<br>RNFL thickness in OCT;Timepoint(s) of evaluation of this end point: month 0-36<br>