E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Duchenne Muscular Dystrophy |
Muskeldystrophie vom Typ Duchenne |
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E.1.1.1 | Medical condition in easily understood language |
Duchenne Muscular Dystrophy |
Muskeldystrophie vom Typ Duchenne |
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E.1.1.2 | Therapeutic area | Diseases [C] - Musculoskeletal Diseases [C05] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To assess safety and efficacy of Sunphenon EGCG in patients with Duchenne Muscular Dystrophy
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E.2.2 | Secondary objectives of the trial |
To compare secondary clinical endpoints between the verum and the placebo group
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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
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E.5 End points |
E.5.1 | 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) |
- Unerwünschte Ereignisse und GHDL Werte(Verum vs Placebo, Monate 0-12 und Monate 12-36)
- 6 Minute Gehtest (Differenz zwischen Monat 0 und 36) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
after 12 and 36 months |
nach 12 und 36 Monaten |
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E.5.2 | Secondary end point(s) |
- Progression (MRC Score, HAMA Score, Time funtion tests)
- Contractures (neutral-null-methode) |
- Progression gemessen anhand von MRC Summenscore, Hammersmith Scale for Assesment of Motor Ability (HAMA), Time function tests (Aufstehen aus dem Liegen, 10 m Gehen, 4 Stufen steigen, 6 Minuten Gehtest)
- Kontrakturen gemessen mit der Neutral-Null-Methode Zeit bis Verlust der Gehfähigkeit
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
after 36 months |
nach 36 Monaten |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 5 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 5 |