E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10052469 |
E.1.2 | Term | Postictal paralysis |
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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 |
To investigate the efficacy of Xeomin in the treatment of patients with equinovarus foot due to spasticity after stroke. |
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E.2.2 | Secondary objectives of the trial |
To document the safety profile of Xeomin |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
- Post-stroke (ischaemic or hemorrhagic) patients - Lower-limb spasticity with equinovarus (including dynamic equinovarus)- Female or male patients, ≥ 18 - 75 years - For pre-treated patients only: source documentation of the most recent injection session with Botulinum Toxin and sufficient therapeutic response for equinovarus - For pre-treated patients only: Stable treatment with oral antispastic drugs of ≥3 weeks. - Autonomous walking (with or without aid) for at least 10 meters - Ashworth Scale ≥1 of the plantar flexors - Ashworth Scale ≥1 of the ankle/foot invertors - Foot plantiflexion during swing phase - Foot inversion during swing phase - maximum active ankle ROM at least limited to 10 in the affected side. |
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E.4 | Principal exclusion criteria |
- Limited passive ankle dorsiflexion >0 - Flaccid drop foot - Planned concomitant treatment with Botulinum Toxin of any serotype and for any body region - Previous or planned treatment with phenol- or alcohol-injection in the target limb - Previous surgical treatment of spasticity in the target muscle(s) - Severe atrophy of the target limb muscles - Limited passive ankle pronation Please define - Pregnancy and lactation - Non complete rehabilitation program which is during the last 4 weeks preceding screening - - Mini Mental State Examination <24 - Previous focal treatments for lower limb spasticity. Except treatment with Botulinum Toxin ≥ 5 months before screening visit. - Fixed contracture, defined as severe restriction of the range of joint movement on passive stretch of ankle or knee - Impaired function of lower limb due to any other condition than post-stroke equinovarus. - Severe or uncontrolled systemic disease. - Other muscle hypertonia, e.g., rigidity - INR value > 2.5 on injection day - Result of hematological/clinical chemistry-analysis at baseline which is considered as abnormal and clinically significant (ie indicating the presence of a severe or uncontrolled systemic disease). |
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E.5 End points |
E.5.1 | Primary end point(s) |
To evaluate spasticity of ankle plantiflexors (Primary endpoint) and invertors by the Ashworth Scale |
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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 | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
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) | 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 | No |
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 | 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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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.8.5 | 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 | 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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 0 |