SUNIMUD - Sunphenon EGCg (Epigallocatechin-Gallate) in Duchenne Muscular Dystrophy

• Register: EUCTR
• Last refreshed on: 14 June 2021
• Main ID: EUCTR2009-016482-28-DE
• Date of registration: 15/03/2010
• Prospective Registration: Yes
• Primary sponsor: Charite Universitätsmedizin Berlin
• Public title: SUNIMUD - Sunphenon EGCg (Epigallocatechin-Gallate) in Duchenne Muscular Dystrophy
• Scientific title: SUNIMUD - Sunphenon EGCg (Epigallocatechin-Gallate) in Duchenne Muscular Dystrophy - SUNIMUD
• Date of first enrolment: 25/06/2010
• Target sample size: 40
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-016482-28
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: no; Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Germany

Contacts

• Name: Sponsor Deputy
• Affiliation: Charite

• Name: Sponsor Deputy
• Affiliation: Charite

Key inclusion & exclusion criteria

Inclusion criteria:
• Duchenne Muscular Dystrophy
• Male patients > 4 years
• ability to walk without help (a minimum of 75 meters)
• maximum 2 cups of black tea, no consumption of grean tee, no consumption of greater amounts of grapefriut juice
• Informed consent of parents

Are the trial subjects under 18? yes
Number of subjects for this age range: 40
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
• serious other organic disease
• known intolerance of Sunphenon
• massiv and protracted exposure to sun
• participation in other interventional clinical trials on pharmaceuticals or medical devices during the study or 3 months before
• futher primary psychiatric/neurologic disorders
• known allergy against Sunphenon EGCg or additives of the study medication or placebo capsules
• longterm intake of liver toxic medication



Age minimum:
Age maximum:
Gender:
Female: no
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Duchenne Muscular Dystrophy

Intervention(s)

Product Name: Sunphenon EGCG
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Sunphenon
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Primary Outcome(s)

Main Objective: To assess safety and efficacy of Sunphenon EGCG in patients with Duchenne Muscular Dystrophy

Secondary Objective: To compare secondary clinical endpoints between the verum and the placebo group

Primary end point(s): - Adverse events and GHDL values (Verum vs Placebo, Months 0-12 and Months 12-36)
- 6 Minutes Walking Test (Differenz between Month 0 and 36)

Timepoint(s) of evaluation of this end point: after 12 and 36 months

Secondary Outcome(s)

Secondary end point(s): - Progression (MRC Score, HAMA Score, Time funtion tests)
- Contractures (neutral-null-methode)

Timepoint(s) of evaluation of this end point: after 36 months

Secondary ID(s)

SUNIMUD

Source(s) of Monetary Support

aktion benni & co.

Deutsche Gesellschaft für Muskelkranke e.V.

Ethics review

Status: Approved
Approval date: 25/06/2010
Contact: