E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Migraine Prevention |
Prevención de la migraña |
|
E.1.1.1 | Medical condition in easily understood language |
Migraine Headaches |
Migraña Cefalea |
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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 | 19.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10027599 |
E.1.2 | Term | Migraine |
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 evaluate the effect of AMG 334 compared to placebo on the proportion of patients with at least 50% reduction from baseline in monthly migraine days |
Evaluar el efecto de AMG 334 en comparación con placebo sobre la proporción de pacientes con reducción de al menos el 50% respecto a la basal de los días con migraña al mes |
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E.2.2 | Secondary objectives of the trial |
To evaluate the effect of AMG 334 compared to placebo on the change from baseline of monthly migraine days To evaluate the effect of AMG 334 compared to placebo on the “impact on everyday activities” domain as measured by the MPFID To evaluate the effect of AMG 334 compared to placebo on the “physical impairment” domain as measured by the Migraine Physical Function Impact Diary (MPFID) To evaluate the effect of AMG 334 compared to placebo on change from baseline in monthly acute migraine-specific medication treatment days To evaluate the effect of AMG 334 compared to placebo on the proportion of patients with at least 75% reduction from baseline in monthly migraine days To evaluate the effect of AMG 334 compared to placebo on the proportion of patients with a 100% reduction from baseline in monthly migraine days To evaluate the safety, tolerability, and immunogenicity of AMG 334 |
Evaluar el efecto de AMG 334 en comparación con placebo sobre el cambio respecto a la basal de los días con migraña al mes. Evaluar el efecto de AMG 334 en comparación con placebo sobre el dominio “impacto sobre las actividades cotidianas” medido con el diario del impacto de la migraña en la función física (Migraine Physical Function Impact Diary; MPFID). Evaluar el efecto de AMG 334 en comparación con placebo sobre el dominio “deterioro físico” medido con el diario del impacto de la migraña en la función física (MPFID). Evaluar el efecto de AMG 334 en comparación con placebo sobre el cambio respecto a la basal de los días de tratamiento con medicamentos específicos para la migraña aguda al mes. Evaluar el efecto de AMG 334 en comparación con placebo sobre la proporción de pacientes con reducción de al menos el 75% respecto a la basal de los días con migraña al mes.
Refiérase al protocolo para resto de objetivos. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Documented history of migraine (with or without aura) for >/= 12 months prior to screening according to the International Classification of Headache Disorders, 3rd Edition (ICHD-3) - 4 to 14 days per month of migraine symptoms (based on ICHD-3 criteria) on average across the 3 months prior to screening based on retrospective reporting - <15 days per month of headache symptoms (ie migraine and non-migraine) - Failed 2 to 4 prior migraine prophylaxis treatments out of the following: Propranolol/metoprolol, topiramate, flunarizine, valproate/divalproex, amitriptyline, venlafaxine, lisinopril, candesartan, locally approved products (e.g. oxeterone or pizotifen) |
- Antecedentes documentados de migraña (con o sin aura) durante >/= 12 meses antes de la selección, de acuerdo con la tercera edición de la clasificación internacional de las cefaleas (International Classification of Headache Disorders) (ICHD-3) - 4 a 14 días al mes, en promedio, con síntomas de migraña (según los criterios de la ICHD-3 durante los 3 meses anteriores a la selección, basándose en comunicaciones retrospectivas - < 15 días al mes con síntomas de cefalea (migraña y no migraña) - Haber fracasado entre 2 y 4 tratamientos profilácticos de la migraña anteriores,entre los siguientes: propranolol/metoprolol, topiramato, flunarizina, valproato/divalproex, amitriptilina, venlafaxina, lisinopril, candesartán, productos aprobados localmente (p. ej., oxeterona o pizotifeno) |
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E.4 | Principal exclusion criteria |
- Older than 50 years of age at migraine onset - Unable to differentiate migraine from other headaches - History of cluster headache or hemiplegic migraine headache - Failed more than 4 prior migraine prophylaxis treatments [as specified in protocol] - Use of a prophylactic migraine medication within 5 half-lives, or a device or procedure within one month prior to the start of the baseline phase or during the baseline phase - Prior Botulinum toxin A treatment in the head/neck region (including cosmetic use or other licensed indications for Botox ®) within 4 months prior to start of the baseline phase - Use of the following for any indication in the 1 month prior to the start of the baseline phase or during the baseline phase: o ergotamines or triptanes ≥10 days/month, or o simple analgesics (NSAIDs, acetaminophen, paracetamol) ≥15 days/month, or o opioid- or butalbital-containing analgesics ≥4 days/month |
- Más de 50 años de edad en el momento del comienzo de la migraña - Incapacidad para diferenciar la migraña de otras cefaleas - Antecedentes de cefalea en racimos (cluster) o migraña hemipléjica - Fracaso de más de 4 tratamientos profilácticos de la migraña previos (como especifica protocolo) - Uso de alguna medicación profiláctica para la migraña en el plazo de 5 semividas, o de un dispositivo o procedimiento en el plazo de un mes antes del inicio de la etapa basal o durante la etapa basal - Tratamiento previo con toxina botulínica A en la zona de cabeza/cuello (incluido el uso cosmético u otras indicaciones autorizadas de Botox ®) en los 4 meses anteriores al inicio de la etapa basal - Uso de los siguientes productos para alguna indicación durante el mes anterior al inicio de la etapa basal: . ergotaminas o triptanos ≥10 días/mes, o . analgésicos corrientes (AINEs, acetaminofén, paracetamol) >/=15 días/mes, o . analgésicos opiáceos o con butalbital >/=4 días/mes |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Achievement of at least a 50% reduction from baseline in monthly migraine days in the last month (month 3) of the double-blind epoch |
Lograr al menos una reducción del 50% respecto a la basal de los días con migraña al mes, durante el último mes (Mes 3) de la etapa de tratamiento doble ciego. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
Change from baseline on monthly migraine days in the last month of the double-blind epoch Change from baseline on MPFID/”impact on everyday activities” domain in the last month of the double-blind epoch Change from baseline on MPFID/”physical impairment” domain in the last month of the double-blind epoch Change from baseline of monthly acute migraine medication treatment days in the last month of the double-blind epoch The achievement of at least a 75% reduction from baseline in monthly migraine days in the last month of the double-blind epoch The achievement of at least a 100% reduction from baseline in monthly migraine days in the last month of the double-blind epoch. Occurrence of cardiovascular events and evaluation of anti-drug antibodies in this patient population |
Cambio respecto a la basal de los días con migraña al mes durante el último mes de la etapa doble ciego Cambio respecto a la basal en el dominio MPFID/“impacto sobre las actividades cotidianas” durante el último mes de la etapa doble ciego Cambio respecto a la basal en el dominio MPFID/“deterioro físico” durante el último mes de la etapa doble ciego Cambio respecto a la basal de los días al mes de tratamiento con medicamentos específicos para la migraña aguda durante el último mes de la etapa doble ciego Alcanzar una reducción de al menos el 75% respecto a la basal de los días con migraña al mes, durante el último mes de la etapa doble ciego Alcanzar una reducción de al menos el 100% respecto a la basal de los días con migraña al mes, durante el último mes de la etapa doble ciego Aparición de acontecimientos cardiovasculares y evaluación de anticuerpos antifármaco en esta población de pacientes |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
For full details, please refer to the schedule of assessments table in the protocol. |
Para más detalles, por favor refiérase al calendario de evaluaciones del protocolo |
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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 | Yes |
E.6.3 | Therapy | No |
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 | Yes |
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 |
Antibody testing; Further blood sampling for future biomarker development |
Pruebas de anticuerpo Muestras de sangre para el desarrollo de biomarcadores. |
|
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) | Yes |
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 | 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) | 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
| 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 | 7 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 76 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Australia |
Austria |
Belgium |
Czech Republic |
Denmark |
Finland |
France |
Germany |
Greece |
Italy |
Netherlands |
Norway |
Spain |
Sweden |
Switzerland |
United Kingdom |
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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
|
LVLS |
Última visita del último paciente |
|
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 | 2 |
E.8.9.1 | In the Member State concerned days | |
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 | 2 |