E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
post-stroke spasticity of the lower limb |
Espasticidad de las extremidades inferiores después de un ictus |
|
E.1.1.1 | Medical condition in easily understood language |
increased muscle tension / uncontrollable muscle stiffness in the leg after a stroke |
|
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 | 14.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10058977 |
E.1.2 | Term | Spastic paresis |
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. |
Investigar la eficacia y la seguridad de NT 201 en comparación con placebo en el primer ciclo doble ciego, y en 3 ciclos subsiguientes de tratamiento abierto con una duración total del periodo de tratamiento de 48 semanas en pacientes no tratados previamente con Toxina Botulínica [TXB] o pretratadas con TXB en la indicación de espasticidad de las extremidades inferiores después de un ictus. Se inyectará una dosis fija total de 400 unidades [U] de NT 201 por ciclo a intervalos de 12 semanas entre inyecciones. |
|
E.2.2 | Secondary objectives of the trial |
there are no secondary objectives |
|
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 |
Edad de 18 a 80 años Espasticidad de las extremidades inferiores Un periodo de ? 3 meses desde el último ictus Necesidad de 400 U de toxina botulínica tipo A |
|
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 corporal < 50 kg Contractura fija de las extremidades inferiores Trastornos generalizados de la actividad muscular como miastenia grave que impida el uso de toxina botulínica tipo A Infección en la zona de inyección |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Change from baseline in Ashworth Scale Score for plantar flexors |
Cambios respecto al valor basal en la Escala de Ashworth para los flexores plantares |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
· Response rate for plantar flexors 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. |
?Índice de respuesta para los flexores plantares en todas las visitas posteriores al periodo basal en pacientes con una mejora (reducción) de al menos 1 punto respecto al valor basal en la EAS. ?EAS para flexores plantares en todas las visitas y cambios desde el periodo basal en todas las visitas posteriores a éste |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Week 4, 8, 12 |
Semana 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 | 5 |
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 |
el final del ensayo se define como la última visita del último paciente sometido al ensayo |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 1 |
E.8.9.2 | In all countries concerned by the trial days | 0 |