E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Multiple Sclerosis patients treated with nabiximols (Sativex¿, Almirall) |
Pazienti affetti da Sclerosi Multipla in trattamento con Sativex |
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E.1.1.1 | Medical condition in easily understood language |
Multiple Sclerosis patients treated with nabiximols (Sativex¿, Almirall) |
Pazienti affetti da Sclerosi Multipla in trattamento con Sativex |
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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 | 21.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10063399 |
E.1.2 | Term | Relapsing-remitting multiple sclerosis |
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 | 20.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10039720 |
E.1.2 | Term | Sclerosis multiple |
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 |
To assess the possible improvement of urinary dysfunction using the urodynamic evaluation in MS patients affected by urinary disturbances and eligible to the treatment with Sativex |
Valutare l¿efficacia di Sativex nel ridurre i disturbi sfinterici urinari in pazienti avviati a tale trattamento secondo le attuali linee guida AIFA |
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E.2.2 | Secondary objectives of the trial |
1. to evaluate the improvement of urinary disturbances by means of self-reported scales 2. to correlate subjective amelioration of bladder dysfunction to parameters at the urodynamic tests 3. to evaluate improvement in spasticity and its related disorders (spasms, pain) and its correlation with amelioration of urodynamic parameters 4. to assess the possible correlation between the changes in urinary symptoms and the motor performance (evaluated by means of the Timed 10-Meters Walk Test) [14] 5. to assess the possible correlation between the improvement of bladder dysfunction and cannabinoids doses
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1. valutare il miglioramento dei disturbi urinari attraverso scale di autovalutazione 2. correlare il miglioramento soggettivo di disturbi vescicali ai parametri valutati al test urodinamico 3. valutare il miglioramento della spasticit¿ e dei disordini ad essa correlati (spasmi muscolari, dolore) e la correlazione con il miglioramento dei parametri urodinamici 4. valutare la possibile correlazione tra le modifiche dei sintomi urinari e la performance motoria (valutata tramite Test del cammino dei 10 metri) 5. valutare la possibile correlazione tra miglioramento dei disturbi vescicali e la dose di cannabinoidi assunta
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Patients who will start therapy with Sativex according to the judgment of the physician, and who are eligible to the treatment following AIFA guidelines - Patients aged 18 - 75 years (inclusive) - Patients with a diagnosis of Relapsing-Remittent, Secondary Progressive and Primary Progressive MS, according to the revised McDonald criteria for MS diagnosis 2010 [18] - Kurtzke EDSS score = 8.0 [19] - Patients with anamnestic report of urinary disturbances - Patients able to give valid informed consent to take part in the study
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- Pazienti candidati al trattamento con Sativex secondo giudizio clinico ed eleggibili in accordo con le linee guida AIFA - Pazienti di età compresa tra 18 e 75 anni - Pazienti con diagnosi di Sclerosi Multipla Recidivante-Remittente, Secondariamente Progressiva e Primariamente Progressiva, secondo i criteri diagnosti di Mc Donald 2010 - Pazienti con EDSS = 8.0 - Pazienti con anamnesi positiva per disturbi sfinterici urinari - Pazienti in grado di dare un valido consenso informato per la partecipazione allo studio |
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E.4 | Principal exclusion criteria |
- Male patients affected by benign prostatic hypertrophy - Presence of urinary infection at baseline or any other contraindications to urodynamic examination - Hypersensitivity to any active ingredient in Sativex product or to any of the excipients listed in the local Sativex product information
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- Pazienti di sesso maschile, affetti da un'ipertrofia prostatica benigna - presenza, alla visita di baseline, di infezioni alle vie urinarie o di altre controindicazioni all'esame urodinamico - ipersensibilità ad una qualsiasi componente del farmaco Sativex o a qualsiasi degli eccipianti riportati nel foglietto illustrativo
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E.5 End points |
E.5.1 | Primary end point(s) |
Improvement in urodynamic parameters between pre- and post-treatment evaluations: amelioration of urodynamic test will be defined as the combination of the reduction of at least 20 cmH2O in the amplitude of the maximal detrusorial contraction plus the increase of at least one third of the baseline bladder filling capacity. |
Miglioramento dei parametri urodinamici tra valutazione pre- e post-trattamento: tale miglioramento sarà definito come la combinazione tra la riduzione di almeno 20 mmHg della ampiezza della massima contrazione detrusoriale e incremento di almeno un terzo della capacità di riempimento vescicale rispetto al valore del baseline. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
(T=0; T=1 30 +/-7d; T=6 180+/-7d) |
(T=0; T=1 30 +/-7gg; T=6 180+/-7gg) |
|
E.5.2 | Secondary end point(s) |
Improvement in self-reported scales about urinary disturbances (urinary diary), in particular frequency of micturitions, episodes of diurnal and nocturnal incontinence, episodes of nocturnal micturition, micturial hesitation ; Correlation between changes in urinary disturbances evaluated by urodynamic evaluation and spasticity evaluated by Numerical Rating Scale (NRS) [15], and motor improvement evaluated by the Timed 10-Meters Walk Test; Correlation between changes in urinary symptoms evaluated by urinary diary and spasticity evaluated by NRS, and motor improvement evaluated by the Timed 10-Meters Walk Test; Amelioration of spasticity, evaluated by means of and by means of the Ashworth Scale [16]; Amelioration of motor performance evaluated by means of the Timed 10-Meters Walk Test; Improvement of VAS scales for: spasms, tremors and pain [17]; Correlation between the whole number of puffs taken from baseline to T1 and from T1 to T6 and: changes in urodynamic parameters, amelioration of urinary symptoms evaluated by means of the urinary diary, results at the NRS and the Timed 10-Meters Walk Test, evaluated at the same time points |
Miglioramento dei parametri delle valutazioni soggettive riferite ai disturbi urinari (diario minzionale), in particolare riguardo a frequenza delle minzioni, episodi di incontinenza diurna e notturna, episodi di minzione notturna, esitazione minzionale.; Correlazione tra modifiche dei ai disturbi urinari valutati tramite esame urodinamico e spasticit¿ valutata tramite la scala Numerical Rating Scale (NRS) [15], e miglioramento della performance motoria valutata tramite il test dei 10 metri (Timed 10-Meters Walk Test) ; Correlazione tra il cambiamento dei sintomi urinari valutati tramite diario minzionale e spasticit¿ valutata tramite la scala Numerical Rating Scale (NRS), e miglioramento della performance motoria valutata tramite il test dei 10 metri (Timed 10-Meters Walk Test) ; Miglioramento della spasticit¿ valutata tramite Ashworth Scale [16]; Miglioramento della performance motoria valutata tramite il test dei 10 metri (Timed 10-Meters Walk Test); Miglioramento della scala VAS [17] per i seguenti disturbi: spasmi muscolari, tremore, dolore ; Correlazione tra il numero totale di puff assunto tra il baseline e T1 e tra T1 e T6 e: modifiche dei parametri urodinamici, miglioramento dei sintomi urinari valutati tramite diario minzionale, risultati alla NRS e al test dei 10 passi, valutati ai medesimi time-points |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
(T=0; T=1=30 +/-7d; T=6=180+/-7d); (T=0; T=1=30 +/-7d; T=6=180+/-7d); (T=0; T=1=30 +/-7d; T=6=180+/-7d); (T=0; T=1=30 +/-7d; T=6=180+/-7d); (T=0; T=1=30 +/-7d; T=6=180+/-7d); (T=0; T=1=30 +/-7d; T=6=180+/-7d); (T=0; T=1=30 +/-7d; T=6=180+/-7d) |
(T=0; T=1=30 +/-7gg; T=6=180+/-7gg); (T=0; T=1=30 +/-7gg; T=6=180+/-7gg); (T=0; T=1=30 +/-7gg; T=6=180+/-7gg); (T=0; T=1=30 +/-7gg; T=6=180+/-7gg); (T=0; T=1=30 +/-7gg; T=6=180+/-7gg); (T=0; T=1=30 +/-7gg; T=6=180+/-7gg); (T=0; T=1=30 +/-7gg; T=6=180+/-7gg) |
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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 | 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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
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
| 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
|
day 180 +/- 7 from baseline of the enrollment of the last patient |
180 giorni (+/- 7) dalla data di arruolamento 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 |