E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
hemiplegic shoulder pain |
Dolore alla spalla dell'arto paretico dopo ictus |
|
E.1.1.1 | Medical condition in easily understood language |
shoulder pain after stroke |
Dolore alla spalla dopo ictus |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Musculoskeletal Diseases [C05] |
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 | 10028395 |
E.1.2 | Term | Musculoskeletal and connective tissue disorders |
E.1.2 | System Organ Class | 10028395 - Musculoskeletal and connective tissue 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 aim of this study is to confirm the efficacy and safety of the intra-articular injection of BT-A in a multicentric double blind randomised study. |
valutare l’efficacia della somministrazione intra-articolare della BTX-A nel trattamento dell’HSP in uno studio multicentrico, randomizzato, in doppio cieco, vs somministrazione di intra-articolare di steroide. |
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E.2.2 | Secondary objectives of the trial |
Improvement of upper limb functions and activity.
Improvement of quality of life |
Valutare l'efficacia della somministrazione intra-articolare della BTX-A sulla funzione dell'arto superiore e della spalla, dopo ictus. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
•Patients with hemiparesis and shoulder pain due to first stroke (ischemic or hemorrhagic) admitted in a rehabilitative department to carry out a standard post-acute rehabilitative program.
•Age 18-70 years.
•Pain score of 45 or greater on a 0-100 mm pain visual analog scale (VAS; 0 = no pain, 100 = worst possible pain).
•Duration of HSP for at least one month.
•Pain refractoriness to conventional treatment i.e. common analgesics (such as paracetamol and NSAIDs), slings, strapping and handling of the arm, functional electrical stimulation of shoulder muscles. |
•Pazienti con emiparesi e dolore alla spalla dovuto ad un primo evento cerebrovascolare (ischemico o emorragico) ricoverati in reparti di riabilitazione per effettuare un programma riabilitativo post-acuto standard.
•Età compresa tra 18 e 75 anni.
•Dolore a riposo pari a 45 mm o più ad una scala visuo-analogica (VAS) del dolore compresa tra 0-100 mm (VAS 0= nessun dolore, 100 mm = il peggior dolore possibile).
•Durata del dolore alla spalla superiore ad 1 mese.
•Refrattarietà del dolore ai trattamenti convenzionali, ad esempio comuni analgesici (paraceramolo, FANS), corretto posizionamento dell’arto attraverso tutori, stimolazione elettrica funzionale. |
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E.4 | Principal exclusion criteria |
•Significant spasticity in the upper shoulder joint, defined as a score of 2 or more at the modified Ashworth scale.
•History of shoulder pain or shoulder diseases.
•History of neurological diseases (i.e. Parkinson disease, dystonia).
•History of botulinum toxin treatment. |
•Presenza di una significativa spasticità all’articolazione della spalla, definita come un punteggio di 2 o più alla scala modificata di Ashworth.
•Afasia o emi-inattenzione di entità tale da non consentire una affidabile determinazione della VAS.
•Anamnesi positiva per dolore alla spalla o patologia della spalla.
•Anamnesi positiva per patologie neurologiche (es. malattia di Parkinson, distonia, miastenia, polineuropatie, miopatie).
•Pregressi trattamenti con tossina botulinica. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy outcome will be the reduction in pain severity, measured by VAS score after 4 weeks of treatment, with respect to baseline evaluation. |
Riduzione dopo 4 settimane del dolore alla spalla valutato mediante scala VAS |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
The secondary efficacy outcome will include the following measures: VAS score at the other time points of the study (1 week, 2 weeks, 3 months and 6 months after the treatment), Shoulder Pain and Disability Index (SPADI), Modified Ashworth Scale (MAS), Fugl Meyer Assessment Scale (FMAS), NIH Stroke Scale index (NISS), Functional Independent Measure (FIM), quality of life on short-form (SF)-36 subscales (SF-36). |
Le misure secondarie di efficacia includeranno le seguenti variabili:
•Punteggio VAS a 1 settimana, 2 settimane, 3 mesi e 6 mesi dal trattamento.
•Shoulder Pain and Disability Index (SPADI) a 1 settimana, 2 settimane, 4 settimane, 3 mesi e 6 mesi dal trattamento.
•Scala di Ashworth modificata (MAS) con valutazione dell’articolazione della spalla e del gomito a 1 settimana, 2 settimane, 4 settimane, 3 mesi e 6 mesi dal trattamento.
•Fugl Meyer Assessment Scale (FMAS) a 1 settimana, 2 settimane, 4 settimane, 3 mesi e 6 mesi dal trattamento.
•NIH Stroke Scale Index (NISS) a 1 settimana, 2 settimane, 4 settimane, 3 mesi e 6 mesi dal trattamento.
•Functional Independent Measure (FIM) a 1 settimana, 2 settimane, 4 settimane, 3 mesi e 6 mesi dal trattamento.
•Quality of life on short-form (SF)-36 subscales (SF-36) a 1 settimana, 2 settimane, 4 settimane, 3 mesi e 6 mesi dal trattamento |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | No |
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 | Yes |
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) | Yes |
E.8.2.2 | Placebo | No |
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 | 6 |
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 | No |
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
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 12 |
E.8.9.1 | In the Member State concerned days | 0 |