E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The main objective of this study is to investigate the effect of Botulinum toxin A to improve the Upper Limb dysfunction in Hemiplegic Cerebral Palsy Children and in particular, its impact on Upper limb activity performance and how this might be translate in bimanual activities. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10019475 |
E.1.2 | Term | Hemiplegic infantile cerebral palsy |
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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 |
The main objective of this study is to investigate the effect of Botulinum toxin A to improve the Upper limb dysfunction in Hemiplegic CP Children and in particular, its impact on Upper Limb activity performance and how this might be translate in bimanual activities. |
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E.2.2 | Secondary objectives of the trial |
The second objective is to demonstrate the utility of the Assisting Hand Assessment (AHA) test in the assessment of the effect of Botulinum toxin A on bi-manual activities |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
The participants to this study are aged between 4 and 12 years and have a diagnosis of congenital hemiplegia affecting upper-limb activities but not significative fixed contractures. They have a Manual Ability Classification system( MACS) level between 1 and 4 and a normal education or an IQ > 70. They must have an adapted physiotherapy program before and minimum 9 months after the treatment.
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E.4 | Principal exclusion criteria |
The children who had injection within 6 months previous the inclusion in the lower limb and 9 months in the upper limb will be excluded. Children who participated at a constraint-induced therapy (CIMT) program the year before the study will be automatically excluded. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The main result that is measured at the end of a study is the outcome at 9 months after injection for each group : - at thelevel of deficiency, the investigator will assess the spasticity by the modified Ashworth scale, the grip force by Jamar dynamometer, the joint range of motion by goniometer, the box and block test to measure the manual dexterity. - at the level of activities limitations, we evaluate the children ability to perform daily activities with their upper limbs by using the PEDI and the abilhand-kids questionnaire. - at the level of participation, we give the questionnaire developed by Fougeyrollas : the Assessment of Life Habits ou MHAVIE- Children
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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 | No |
E.6.4 | Safety | No |
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 | 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 | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
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.8.3 |
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 | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
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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Participation at the outcome measures 9 months after injections is the end of the protocole for all of the subjects |
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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 | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |