E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Relapsing-remitting multiple sclerosis |
Sclerosi Multipla Recidivante Remittente |
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MedDRA Classification |
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 |
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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 |
1) To investigate the safety and tolerability of 10, 20, and 40 mg/day ACT-128800 for up to 120 weeks (24 weeks of treatment during study AC-058B201, up to 96 weeks of treatment during study AC-058B202). 2) To investigate the efficacy of 10, 20, and 40 mg/day ACT-128800 for up to 120 weeks (24 weeks of treatment during study AC-058B201, up to 96 weeks of treatment during study AC-058B202). |
1) Valutare la sicurezza e tollerabilita' di 10, 20, e 40 mg/die di ACT-128800 fino a 120 settimane (24 settimane di trattamento durante lo studio AC-058B201, fino a 96 settimane di trattamento durante lo studio AC-058B202). 2) Valutare l'efficacia di 10, 20, e 40 mg/die di ACT-128800 fino a 120 settimane (24 settimane di trattamento durante lo studio AC-058B201, fino a 96 settimane di trattamento durante lo studio AC-058B202). |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
OTHER SUBSTUDIES:
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ALTRI SOTTOSTUDI:
Studi ancillari inclusi in questo protocollo ma implementati solo in centri selezionati: 1) valutazione dei parametri ecocardiografici; 2) valutazione dei parametri oftalmologici tramite OCT.
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E.3 | Principal inclusion criteria |
1. Patients who completed study treatment at their regular Week 24 (EOT) visit within the core study. 2. Women of childbearing potential must have a negative urine pregnancy test at their regular Week 24 visit within the core study and agree to continue using two methods of contraception as required for the core study until 8 weeks after study drug discontinuation. 3. Signed informed consent for participating in the extension study prior to administration of the first dose in the transition period (i.e., prior to continuation of dosing at Visit 11 (Week 24) of the core study). |
1) I pazienti che hanno completato il trattamento dello studio alla visita regolare alla Settimana 24 (EOT) dello studio principale. 2) Le donne in eta' fertile devono avere un risultato negativo al test di gravidanza su urine alla visita regolare alla settimana 24 dello studio principale e accettare di continuare a utilizzare due metodi contraccettivi come richiesto nello studio principale fino a 8 settimane dopo la sospensione del farmaco in studio. 3) Consenso informato firmato per la partecipazione allo studio di estensione prima della somministrazione della prima dose nel periodo di transizione (cioe' prima di continuare la somministrazione alla Visita 11 (Settimana 24) dello studio principale). |
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E.4 | Principal exclusion criteria |
1. Patients meeting at their regular Week 24 (EOT) visit, during the transition period, and/or at Visit E1 any of the study-specific criteria for permanent discontinuation of study drug as defined in Appendix 1, or patients receiving any of the prohibited concomitant medication as outlined in Section 3.3.4.3 and Appendix 8. 2. Any other clinically relevant medical or surgical condition, which, in the opinion of the investigator, would put the patient at risk by participating in the extension study. |
1) I pazienti per i quali alla regolare visita (EOT) alla Settimana 24, durante il periodo di transizione, e/o alla Visita E1, si riscontra uno dei criteri specifici di sospensione permanente del farmaco in studio, o i pazienti che ricevono una delle terapie concomitanti proibite 2) Qualunque altra condizione medica o chirurgica clinicamente rilevante, che, secondo lo sperimentatore, possa mettere il paziente a rischio di partecipazione nello studio di estensione. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The following exploratory endpoints will be analyzed: 1. Annualized confirmed relapse rate. 2. Time to first confirmed relapse. Additional endpoints/parameters based on MRI scans, as well as endpoints related to safety and tolerability will be investigated. |
I seguenti endpoint esplorativi di efficacia saranno analizzati: 1. Tasso annualizzato di recidiva confermata. 2. Tempo di comparsa della prima recidiva confermata. Saranno analizzati ulteriori endpoints/parametri basati sulla RMN cosi' come endpoints relativi alla sicurezza e tollerabilita'. |
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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 | Yes |
E.6.7 | Pharmacodynamic | Yes |
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 |
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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 | No |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
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 | Yes |
E.8.1.7.1 | Other trial design description |
studio di estensione dello studio di Fase 2b AC-058B201 |
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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 | 3 |
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 | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 80 |
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 | 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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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 | 27 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 27 |
E.8.9.2 | In all countries concerned by the trial days | 0 |