E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Spasticity following stroke |
Spasticità a seguito di ictus |
|
E.1.1.1 | Medical condition in easily understood language |
Spasticity following stroke |
Spasticità a seguito di 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 | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10041416 |
E.1.2 | Term | Spasticity |
E.1.2 | System Organ Class | 100000004852 |
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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 assess if Sativex is able to reduce spasticity in chronic stroke patients |
Verificare se Sativex è in grado di ridurre la spasticità in Pazienti con esito di ictus cerebri |
|
E.2.2 | Secondary objectives of the trial |
To evaluate the tolerability of Sativex |
Valutare la tollerabilità del Sativex |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
patients of either sex, at least 18 years of age, with a history of stroke (hemorrhagic or ischemic) occurred at least 3 months earlier and presence of spasticity rated between 1 and 3 at the Ashworth Modified Scale (MAS) in at least one of the following segments: flexor muscles of the wrist, flexor muscles of the forearm, extensor muscles of the leg, foot plantiflexors.
Current antispastic therapy has to be stable since at least three months before inclusion into the study and will be maintained stable across the study.
|
Pazienti maggiorenni di sesso maschile o femminile con esito di ictus ischemico o emorragico avvenuto almeno 3 mesi prima e spasticità quantificabile tra 1 e 3 della Scala di Ashworth Modificata (MAS). Devono essere coinvolti almeno uno sei seguenti segmenti: flessori del polso, flessori dell'avambraccio, estensori di gamba e plantiflessori del piede |
|
E.4 | Principal exclusion criteria |
treatment with botulinum toxin injection for the relief of spasticity within 4 months prior to the screening visit, CHA2DS2VASc score (Melgaard, 2015) higher than 6, presence of a cardiovascular risk at cardiological visit, pregnant or lactating women, or any significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, may influence the result of the study, or the patient’s ability to participate in the study. |
Trattamento con tossina botulinica nei 4 mesi precedenti all'inclusione nello studio, punteggio CHA2DS2VASc maggiore di 6 (ad attestare un eccessivo rischio cardiovascolare) o altri elementi che giustifichino un eccessivo rischio cardiovascolare alla valutazione cardiologica. Donne gravide o in allattamento. Qualsiasi condizione clinica concomitante che a giudizio del ricercatore possa determinare un rischio eccessivo per il paziente o influenzare la qualità dei risultati dello studio. Incapacità del paziente a comprendere le modalità dello studio o fornire il proprio consenso informato |
|
E.5 End points |
E.5.1 | Primary end point(s) |
To assess the effect of the tested treatment on muscle spasticity assessed with the stretch reflex and the 0-10 numeric rating scale for spasticity (NRS) |
Valutare l'effetto del trattamento testato sulla spasticità muscolare tramite la scala numerica per la spasticità e l'ampiezza del riflesso da stiramento |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
1) Daily spasms count
2) Bladder dysfunction (0-10 numeric rating scale)
3) Subjective amount of pain (O-10 numeric rating scale)
4) Number of Patients with adverse events and seriouse adverse events
5) Number of treatments interruptions related to adverse events
6) Systolic/ dyastolic blood pressure and heart rate
7) Modified Ashworth spasticity scale score |
1) Conteggio giornaliero degli spasmi
2) Disfunzione della vescica (scala numerica da 0 a 10)
3) Quantificazione soggettiva del dolore (scala numerica da 10 a 0)
4) Numero di pazienti con eventi avversi ed eventi avversi gravi
5) numero di interruzioni del trattamento correlate ad eventi avversi
6) Pressione sanguigna sistolica/diastolica e frequenza cardiaca
7) Valutazione del punteggio della scala di spasticità di Ashworth |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
1) 12 weeks
2) 12 weeks
3) 12 weeks
4) 12 weeks
5) 12 weeks
6) 12 weeks
7) 12 weeks |
1) massimo 12 settimane
2) 12 settimane
3) 12 settimane
4) 12 settimane
5) 12 settimane
6) 12 settimane
7) 12 settimane |
|
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 | 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) | 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 | 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 | No |
E.8.1.6 | Cross over | Yes |
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 1 |
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 | No |
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 | 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 |