E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Spastic hemiparesis with involvement of the M. biceps brachii |
|
E.1.1.1 | Medical condition in easily understood language |
Subjects with constraint movability after e.g. a stroke with increased muscle tone |
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E.1.1.2 | Therapeutic area | Body processes [G] - Physiological processes [G07] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
-Visualizing and monitoring the emerging denervation edema after BoNT injection in the MBB and drawing correlations with BoNT induced muscle weakness by measurement of clinical parameters
-To assess whether physical exercise (two groups with/without exercise) influences the size of the denervation edema and/or the extent of botulinum toxin induced weakness |
|
E.2.2 | Secondary objectives of the trial |
-To illustrate MRI alterations with the temporally closest imaging to the clinical onset of BoNT effect
-To assess whether the time of onset of the clinical effect after BoNT injection is influenced by muscle work
-To demonstrate long term structural alterations in the SBB after BoNT injection |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Upper limb spasticity, involvement of M. biceps brachii
• Age 18-80 years
• Male and female
• modified ashworth scale score ≤2
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E.4 | Principal exclusion criteria |
Absolute:
• patients under anticoagulation
• presence of a myasthenic syndrome, myopathies or myotonias
• presence of a cardiac pacemaker
• pregnancy and current breast feeding
Relative:
• implanted metal parts (stent, prosthesis,..), dependend on year of implantation
• claustrophobia
• inflammation at the designated injection site
- spastic tetraparesis
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|
E.5 End points |
E.5.1 | Primary end point(s) |
Monitoring of the emerging denervation edema after intramuscular Botulinumtoxin injection and the correlation with induced muscle weakness and reduction of spasticity measured by clinical examination and dynamometric assessment |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
baseline (before BoNT injection) and 7 times after injection: at day 1,3,7,14, 21 and after 8 and 16 weeks |
|
E.5.2 | Secondary end point(s) |
-To illustrate MRI alterations with the temporally closest imaging to the clinical onset of BoNT effect
-To assess whether the time of onset of the clinical effect after BoNT injection is influenced by muscle work
-To demonstrate long term structural alterations in the SBB after BoNT injection |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
baseline (before BoNT injection) and 7 times after injection: at day 1,3,7,14, 21 and after 8 and 16 weeks |
|
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 | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | Yes |
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 | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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 | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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 | No |
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
|
16 weeks after injection |
16 Wochen nach Injektion |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | |