E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Multiple Sclerosis |
Esclerosis múltiple |
|
E.1.1.1 | Medical condition in easily understood language |
Multiple sclerosis |
Esclerosis múltiple |
|
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 | 16.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10028245 |
E.1.2 | Term | Multiple sclerosis |
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 |
1 - To evaluate the safety and tolerability of XCEL-MC-ALPHA by: a. Overall incidence of adverse events by treatment b. Incidence of adverse events by organ system preferred term, by treatment. c. Severity of adverse events per treatment. d. Intensity of adverse events per treatment. e. Causation by treatment. |
Evaluar la seguridad y tolerabilidad de XCEL-MC-ALPHA mediante: a. Incidencia de acontecimientos adversos globales, por tratamiento b. Incidencia de acontecimientos adversos por órganos y sistemas según término preferente, por tratamiento. c. Gravedad de los acontecimientos adversos, por tratamiento. d. Intensidad de los acontecimientos adversos, por tratamiento. e. Relación de causalidad, por tratamiento. |
|
E.2.2 | Secondary objectives of the trial |
Assess the effectiveness of XCEL-MC-ALPHA determined by the cumulative number of lesions that enhance with gadolinium T1 in sequence magnetic resonance in both treatment periods, in the group initially assigned to placebo and the group initially assigned to XCEL-MC-ALPHA |
Evaluar la eficacia de XCEL-MC-ALPHA mediante el número acumulado de lesiones que se realzan con gadolinio en la secuencia T1 en ambos periodos de tratamiento, en el grupo asignado inicialmente a placebo y en el grupo asignado inicialmente a XCEL-MC-ALPHA |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients with MS (McDonald 2010) Clinical course of patients with relapsing-remitting MS or secondary progressive (Lublin and Reingold 1996) Age between 18 and 60 Patients in whom is not indicated or are not in a position to begin treatment with drugs that modify disease available for MS, after the researcher has been informed of their benefits and potential adverse events, or who do not respond adequately to standard therapy or can not tolerate EDSS < o = 6.5 At least nine T2 lesions Active MS, defined by: At least one outbreak in the last year or At least one Gd-enhancing lesion in the last 6 months Have signed the informed consent for participation in the stud |
Pacientes con EM (McDonald 2010) Pacientes con curso clínico de la EM Recurrente-Remitente o Secundariamente Progresivo (Lublin y Reingold 1996) Edad entre 18 y 60 años Pacientes en los que no esté indicado o no deseen iniciar tratamiento con fármacos modificadores de la enfermedad disponibles para la EM, después de que el investigador les haya informado de sus beneficios respectivos y de los posibles acontecimientos adversos, o que no responden adecuadamente al tratamiento habitual o no lo toleran. EDSS < o = 6.5 Al menos nueve lesiones en T2 EM activa, definida por: Al menos un brote en el último año, o Al menos una lesión realzada con Gd en los últimos 6 meses Haber firmado el consentimiento informado de participación en el estudio. |
|
E.4 | Principal exclusion criteria |
Patients pre-treated with: - Interferon beta or glatiramer acetate 3 months prior to screening - Natalizumab or fingolimod in the 6 months prior to screening - Mitoxantrone, cyclophosphamide or other immunosuppressive therapy at any time - Experimental treatment within 3 months prior to screening MS attack in the 4 weeks prior to randomization Serum creatinine> 2.0 mg / dl. If serum creatinine is> 1.2 mg / dl, measure glomerular filtration rate. Patients were excluded if the filtrate is <60 ml/minuto/1, 73 m2 Infectious disease active or uncontrolled Fertile patients who are not using a suitable method of contraception (at the discretion of the investigator). If the patient is postmenopausal or sterile must be documented in the medical record. |
Tratamiento previo con: - Interferón beta o acetato de glatiramer en los 3 meses previos a la selección - Natalizumab o fingolimod en los 6 meses previos a la selección - Mitoxantrona, ciclofosfamida u otro tratamiento inmunosupresor en cualquier momento Tratamiento experimental en los 3 meses previos a la selección Brote de EM en las 4 semanas anteriores a la aleatorización Creatinina sérica > 2.0 mg/dl. Si la creatinina sérica es > 1.2 mg/dl, se debe medir el filtrado glomerular. Los pacientes se excluirán si el filtrado es <60 ml/minuto/1,73 m2 Enfermedad infecciosa activa o no controlada Pacientes fértiles que no estén utilizando un método adecuado de anticoncepción (a criterio del investigador). Si la paciente es menopáusica o estéril debe estar documentado en la historia clínica. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Safety and tolerability |
Seguridad y tolerabilidad |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
4, 12, 24, 28, 36 and 48th weeks |
4, 12, 24, 28, 36 y 48 semanas |
|
E.5.2 | Secondary end point(s) |
Lesions that enhance with gadolinium T1 in sequence magnetic resonance |
Lesiones que se realzan con Gd en la RM |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
4, 12, 24, 28, 36 and 48th weeks |
4, 12, 24, 28, 36 y 48 semanas |
|
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) | Yes |
E.7.1.1 | First administration to humans | Yes |
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.8.5 | 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
|
Last visit of the last subject undergoing the trial. |
Última visita del último sujeto incluido en el ensayo. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |