E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
post-stroke spasticity of the lower limb |
Trattamento della spasticità dell'arto inferiore in seguito ad ictus |
|
E.1.1.1 | Medical condition in easily understood language |
increased muscle tension / uncontrollable muscle stiffness in the leg after a stroke |
aumento della tensione muscolare / rigidità muscolare incontrollabile alla gamba dopo un ictus |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | SOC |
E.1.2 | Classification code | 10029205 |
E.1.2 | Term | Nervous system disorders |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
|
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 and safety of NT 201 compared to placebo in the first double-blind cycle, and in 3 subsequent open-label treatment cycles with a total exposure duration of 48 weeks in Botulinum toxin [BTX] treatment-naïve and BTX-pretreated subjects with post-stroke spasticity in the lower limb. A fixed total dose of 400 units [U] NT 201 per cycle will be injected at an interval of 12 weeks between injections. |
L'obiettivo è di determinare l'efficacia e la sicurezza di NT 201 rispetto al placebo nel primo ciclo in doppio cieco (periodo principale) e in tre successivi cicli di trattamento in aperto (periodo OLEX). Lo studio osserverà un periodo di trattamento totale di 48 settimane con la Tossina botulinica (BTX) in soggetti affetti da spasticità dell'arto inferiore in seguito a ictus e naive al trattamento con BTX o precedentemente trattati con BTX. |
|
E.2.2 | Secondary objectives of the trial |
there are no secondary objectives |
no ci sono obiettivi secondari. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Age from 18-80 yrs; Lower limb spasticity Time since stroke greater than 3 months; Need for 400 U Botulinum toxin type A |
Età superiore a 18 anni, Periodo ≥ 3 mesi dall'ultimo ictus che ha causato spasticità dell'arto inferiore; il soggetto deve presentare una necessità clinica di una dose totale di 400 U di NT 201 nell'arto inferiore interessato |
|
E.4 | Principal exclusion criteria |
Body weight below 50kg;
Fixed contractures of the lower limb; Generalized disorders of muscle activity like Myasthenia gravis that preclude use of Botulinum toxin type A; Infection at the injection site |
peso corporeo inferiore a 50 kg;
Contratture fisse agli arti inferiori; Disturbi generalizzati dell'attività muscolare, come la Miastenia gravis, che impediscono l'uso della tossina botulinica di tipo A;
Infezioni nel sito di iniezione; |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Change from baseline in Ashworth Scale Score for plantar flexors |
• Variazione rispetto al basale nella Scala di Ashworth (AS) per i flessori plantari |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
Ashworthflexors at all post-baseline visits for subjects with an improvement (reduction) of at least 1 point from baseline in the AS. · AS for plantar flexors at all visits and changes from baseline at all post-baseline visits |
•Tasso di risposta per i flessori plantari in tutte le visite successive al basale per i soggetti con un miglioramento (riduzione) di almeno 1° punto nell'AS rispetto al basale
·Variazione rispetto al basale nell’ AS per i flessori plantari in tutte le visite successive al basale. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Week 4, 8, 12 |
settimana 4, 8, 12 |
|
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 | 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 | 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) | Yes |
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 | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 32 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Canada |
Russian Federation |
United States |
|
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
|
end of trial is defined as the last visit of the last subject undergoing the trial |
la conclusione della sperimentazione è definita come l'ultima visita dell'ultimo soggetto incluso nello studio |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 25 |
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 | 25 |
E.8.9.2 | In all countries concerned by the trial days | 0 |