E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Spastic equinus foot is a common dynamic deformity in patients with cerebral palsy. This dynamic deformity, mainly caused by spasticity of the soleus, gastrocnemius and tibialis posterior muscles, may lead to gait impairment. |
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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 |
The main objective is to assess the analytical and functional effects of Botox injected into the muscles of the calf on patients with gait impairment due to spastic equinus foot. |
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E.2.2 | Secondary objectives of the trial |
The secondary objective is to do an accurate analysis of the gait of patients with gait impairment due to spastic equinus foot. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
All patients will have unilateral spastic hemiplegia due to vascular or traumatic brain injury, with spastic drop foot impairing gait. Moreover, each patient will be included in a functional rehabilitation program (3 to 5 sessions/week of physiotherapy) during the study. The inclusion criteria are : Unilateral clinical symptoms Equinus foot without fixed contracture Cerebral lesion superior to 2 months Independent gait with or without orthesis
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E.4 | Principal exclusion criteria |
The exclusion criteria are : Absence of prior orthopedic surgery in the lower extremities Absence of major cognitive disorders (MMS > 24) Absence of others factors interfering with gait as judged by investigators
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoints are to analyse, on patients with gait impairment due to spastic equinus foot, the effects of Botox on calf spasticity and on gait (temporospatial parameters, kinematic parameters of ankle, auto-assessment index of gait quality). The secondary endpoints are to analyse, on patients with gait impairment due to spastic equinus foot, the effects of Botox on kinematic parameters of knee and hip during gait, kinetic parameters during gait and static balance in standing position. |
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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 | 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 | Information not present in EudraCT |
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 | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | Information not present in EudraCT |
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 | Information not present in EudraCT |
E.8.5 | The trial involves multiple Member States | Information not present in EudraCT |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Information not present in EudraCT |
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 | Information not present in EudraCT |
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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Last visit of the the last subject enrolled. |
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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 | |
E.8.9.1 | In the Member State concerned days | |