E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Multiple Sclerosis patients |
Soggetti affetti da Sclerosi Multipla |
|
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 | HLGT |
E.1.2 | Classification code | 10012303 |
E.1.2 | Term | Demyelinating disorders |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10052785 |
E.1.2 | Term | Multiple sclerosis acute and progressive |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
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 |
|
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 |
|
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 |
Against this background, the present case-control group study has been designed with the aim to evaluate the impact of Glatiramer Acetate treatment on Multiple Sclerosis-related fatigue, under both a clinical and a paraclinical point of view. |
Questo studio osservazionale longitudinale della durata di 12 mesi, ha come obiettivo primario quello di determinare l'impatto del trattamento iniziale con glatiramer acetato sulla fatica, tramite misure di outcome sia cliniche che di Risonanza Magnetica ed utilizzando come gruppo di controllo pazienti con Sclerosi Multipla benigna (SMB) che non necessitino di terapia immunomodulante. |
|
E.2.2 | Secondary objectives of the trial |
Secondary outcome will be to evaluate the effect of treatment on clinical and MRI outcomes related to the symptom “fatigue” and in particular related to functioning of its brain networks. |
Obiettivo secondario sara' quello di valutare l'effetto del trattamento con Glatiramer Acetato tramite misure di outcome sia cliniche che di Risonanza Magnetica relative al sintomo ''fatica'', valutando in particolare il funzionamento degli specifici network cerebrali correlati alla “fatica”. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Inclusion criteria: - Age between 18 and 60 years; - Diagnosis of multiple sclerosis, according to the revised McDonald criteria [37]; - Relapsing-remitting or benign course; - EDSS score between 0.0 and 5.5 [38]; - For BMS: disease duration of 15 years or longer, EDSS <3.0 |
Criteri di inclusione: - eta' compresa tra 18 e 60 anni; - diagnosi di SM secondo secondo i criteri di McDonald [37]; - decorso recidivante-remittente o benigno; - punteggio EDSS tra 0.0 e 5.5 [38]; - per SMB: durata della malattia di 15 anni o piu', EDSS <3.0. |
|
E.4 | Principal exclusion criteria |
Exclusion criteria: - Relapse or corticosteroid treatment within 30 days before study entry, - Chronic use of psychotropic drugs - Use of other disease-modifying treatments in the previous six months - Clinically significant systemic diseases. |
Criteri di esclusione: - recidiva o trattamento con corticosteroidi, entro 30 giorni prima dell'inizio dello studio; - uso cronico di psicofarmaci; - uso di altre terapie modificanti il decorso della SM nei sei mesi precedenti - malattie sistemiche clinicamente significative. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Against this background, the present case-control group study has been designed with the aim to evaluate the impact of Glatiramer Acetate treatment on Multiple Sclerosis-related fatigue, under both a clinical and a paraclinical point of view. |
Questo studio osservazionale longitudinale della durata di 12 mesi, ha come obiettivo primario quello di determinare l'impatto del trattamento iniziale con glatiramer acetato sulla fatica, tramite misure di outcome sia cliniche che di Risonanza Magnetica ed utilizzando come gruppo di controllo pazienti con Sclerosi Multipla benigna (SMB) che non necessitino di terapia immunomodulante. |
|
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 | No |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
Verificare l'impatto del farmaco sul manifestarsi dei sintomi di fatica provocati dalla malattia. |
|
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 | Yes |
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 | Yes |
E.8.1.7.1 | Other trial design description |
|
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 | 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.8.6 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
| |
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 | 24 |
E.8.9.1 | In the Member State concerned days | 0 |