SUPREMES - Sunphenon in progressive forms of multiple sclerosis

SUPREMES - Sunphenon in progressive forms of multiple sclerosis - SUPREMES

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-005213-22-DE

Enrollment

Registered

2008-08-22

Start date

Unknown

Completion date

Unknown

Last updated

2020-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

primary and secondary progressive forms of multiple sclerosis

Interventions

Product Name: Sunphenon Pharmaceutical Form: Capsule, hard Other descriptive name: Sunphenon EGCg Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200- Pharmaceutica

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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) - T1 hypointensive lesions („black holes“) - changes in the NAA/Cr ratio (spectroscopy) - EDSS - cognitive functions and fatigue - RNFL („retinal nerve fiber layer“) thickness (optic coherencetomography) ;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	—

Measure

Time frame

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) - T1 hypointensive lesions („black holes“) - changes in the NAA/Cr ratio (spectroscopy) - EDSS - cognitive functions and fatigue - RNFL („retinal nerve fiber layer“) thickness (optic coherencetomography) ;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

—

Secondary

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

Countries

Germany

Contacts

Public ContactNeuroCure Clinical Research Center

Charite Universitätsmedizin Berlin

claudia.blum@charite.de004930450 539 728

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026