E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Spasticity of the upper and lower limb of the same body side due to cerebral causes |
Spasticita' degli arti superiori ed inferiori dello stesso lato del corpo dovuta a cause cerebrali |
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E.1.1.1 | Medical condition in easily understood language |
Increased muscle tension/uncontrollable muscle stiffness in the leg and arm of the same body side due to cerebral causes. |
Aumento della tensione muscolare/rigidita' muscolare incontrollabile nelle gambe e nelle braccia dello stesso lato del corpo dovuta a cause cerebrali |
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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 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
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 |
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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 primary objective of this clinical study is to assess the safety of doses of NT 201 of up to 800 U in subjects suffering from spasticity in both upper and lower limbs of the same side of the body due to cerebral causes over a period of up to 48 weeks with flexible injection intervals of 12 to 16 weeks |
L'obiettivo principale di questo studio clinico è valutare la sicurezza delle dosi di NT 201 fino a 800 U in soggetti affetti da spasticita' sia degli arti superiori sia inferiori dello stesso lato del corpo dovuta a cause cerebrali per un periodo fino a 48 settimane con intervalli di iniezioni flessibili da 12 a 16 settimane |
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E.2.2 | Secondary objectives of the trial |
As a secondary objective, this study will evaluate the impact of the administration of NT 201 on several efficacy variables |
Come obiettivo secondario,questo studio valutera' l'effetto della somministrazione di NT201 su diverse variabili di efficacia |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Age from 18-80 yrs - Upper and lower limb spasticity of the same body side due to cerebral causes - Time since event leading to spasticity in the target body side greater than 12 weeks - Need for 800 units Botulinum toxin type A |
-Eta' compresa tra 18 e 80 anni -Spasticita' degli arti superiori ed inferiori dello stesso lato del corpo dovuta a cause cerebrali -Periodo di tempo superiore a 12 settimane dall'evento che ha comportato la spasticita' nel lato target del corpo -Necessita' di 800 unità di tossina botulinica di tipo A |
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E.4 | Principal exclusion criteria |
- Body weight below 50kg - Fixed contractures of the target joint - 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 -Contrattura permanente dell'articolazione target -Disturbi generalizzati dell'attivita' muscolare come Misastenia grave che preclude l'uso della tossina botulinica di tipo A -Infezione del sito di iniezione |
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E.5 End points |
E.5.1 | Primary end point(s) |
Occurence of treatment emergent adverse events (AEs), AEs of special interest (AESIs), and Serious AEs (SAEs) by injection cycle Occurence of treatment-emergent AEs, AESIs and SAEs related to the administration of study medication by injection cycle Investigator's global assessment of tolerability using a 4-point Likert scale at end of injection cycle visits |
-Verificarsi di eventi avversi inaspettati(AEs) al trattamento, AEs di interesse particolare (AESIs), e eventi avversi seri (SAEs) nel ciclo di inizione -Verificarsi di AEs imprevisti al trattamento, AESIs e SAEs correlati alla somministrazione del farmaco in studio nel ciclo di iniezione -Valutazione globale da parte dello sperimentatore di tollerabilita' tramite la scala Likert a 4 punti alla fine delle visite del ciclo di iniezione |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
week 12-16, week 24-32, week 36-48 |
settimana 12-16, settimana 24-32, settimana 36-48 |
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E.5.2 | Secondary end point(s) |
Ashworth Scale (AS) of the target joint selected at study baseline visit -AS of every joint affected by clinical patterns of spasticity and treated at least once, of the same body side as the selected target joint Resistance to passive movement scale (REPAS) Functional ambulation classification (FAC) scale Global attainment scale (GAS) for upper and lower limb, respectively Disability Assessment Scale (DAS) in a selected principal therapeutic target domain affecting the upper limb EuroQoL 5-dimensional questionaire (EQ-5D) Global assessment of efficacy |
-Scala di Ashworth (AS) dell'articolazione target selezionata alla visita di baseline dello studio -AS di ciascuna articolazione affetta da modelli clinici di spasticita' e trattata almeno una volta, della stessa parte del corpo dell'articolazione target selezionata -Scala di Resistenza al movimento passivo (Resistance to passive movement scale REPAS) -Scala di classificazione funzionale di deambulazione(Functional ambulation classification FAC) -Scala di raggiungimento globale (Global attainment scale GAS) rispettivamente per gli arti superiori ed inferiori -Scala di valutazione della disabilita' (Disability Assessment Scale DAS) in un dominio target terapeutico principale selezionato concernente gli arti superiori -Questionario EuroQoL 5-dimensional questionaire (EQ-5D) -Valutazione globale di efficacia |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
from baseline up to week 48 for: AS, REPAS, FAC, DAS,EQ-5D. Up to week 48 for: GAS and Global assessment of efficacy |
Dal baseline fino alla settimana 48 per: AS, REPAS, FAC, DAS,EQ-5D. Fino alla settimana 48 per: GAS e Global assessment of efficacy |
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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 | 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 | Yes |
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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
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.8.2.4 | Number of treatment arms in the trial | 1 |
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 | 8 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 26 |
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 |
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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
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The end of study will be defined as the last visit of the last subject |
La fine dello studio sarà definita come l'ultima visita dell'ultimo paziente |
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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 | 2 |
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 | 2 |
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 |