E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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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 | 20.0 |
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 |
The main goal of the study is to assess the long-term safety of eptinezumab in children and adolescents ages 6 to 17 with chronic or episodic migraine. |
El objetivo principal del estudio es evaluar la seguridad a largo plazo de eptinezumab en niños y adolescentes de 6 a 17 años de edad con migraña crónica o episódica |
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E.2.2 | Secondary objectives of the trial |
Not Applicable |
No aplicable |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- The participant must have completed Week12 (completion) visit of either Study19356A (CM) or Study19357A (EM) immediately prior to enrolment into this OLE study. |
- El participante debe haber completado la visita de la Semana 12 (finalización) del Estudio 19356A (CM) o del Estudio 19357A (EM) inmediatamente antes de la inscripción en este estudio OLE. |
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E.4 | Principal exclusion criteria |
- The participant has an adverse event or other safety concerns that are deemed related to double-blind treatment received in the lead-in study and is considered a potential safety risk by the investigator.
- During lead-in Study19356A or Study19357A: * participant experienced ananaphylactic reaction or another severe and/or serious hypersensitivity reaction to the investigational medicinal product (IMP) infusion, as assessed by the investigator
* the participant had a serum alanine aminotransferase (ALT) or aspartate aminotransferase(AST) value >5 times the upper limit of the reference range that was confirmed by testing <2 weeks later.
* the participant had a serum ALT or AST value >3times the upper limit of the reference range and a serum total bilirubin value >2times the upper limit of the reference range. |
- El participante tiene un acontecimiento adverso u otros problemas de seguridad que se consideran relacionados con el tratamiento doble ciego recibido en el estudio inicial y el investigador lo considera un riesgo potencial de seguridad. - Durante la introducción Study19356A o Study19357A: * el participante experimentó una reacción anafiláctica u otra reacción de hipersensibilidad grave y/o grave a la infusión del medicamento en investigación (IMP), según la evaluación del investigador * el participante tenía un valor sérico de alanina aminotransferasa (ALT) o aspartato aminotransferasa (AST) > 5 veces el límite superior del rango de referencia que se confirmó mediante pruebas < 2 semanas después. * el participante tenía un valor de ALT o AST en suero > 3 veces el límite superior del rango de referencia y un valor de bilirrubina total en suero > 2 veces el límite superior del rango de referencia. |
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E.5 End points |
E.5.1 | Primary end point(s) |
1. Number of Participants With Treatment Emergent Adverse Events |
1. Número de participantes con eventos adversos emergentes del tratamiento |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
1. Time Frame: Baseline up to Week 44 |
1. Marco de tiempo: línea de base hasta la semana 44 |
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E.5.2 | Secondary end point(s) |
1. Free Eptinezumab Plasma Concentration
2. Number of Participants With Specific Anti-Eptinezumab Antibodies (Anti-Drug Antibodies [ADA])
3. Number of Participants With Specific Anti-Eptinezumab Antibodies for Neutralizing Activity (NAb)
4. Change From Baseline in Pediatric Migraine Disability Assessment Questionnaire (PedMIDAS) Score at Weeks 12, 24, and 36
5. Change From Baseline in Monthly Headache Days Averaged Over Weeks 1-12
6. Change From Baseline in Monthly Migraine Days Averaged Over Weeks 1-12
7. Change From Baseline in Rate of Migraines With Severe Pain Intensity Averaged Over Weeks 1-12 |
1. Concentración plasmática de eptinezumab libre 2. Número de participantes con anticuerpos específicos antieptinezumab (Anti-Drug Antibodies [ADA]) 3. Número de participantes con anticuerpos anti-eptinezumab específicos para la actividad neutralizante (NAb) 4. Cambio desde el inicio en la puntuación del Cuestionario de evaluación de discapacidad por migraña pediátrica (PedMIDAS) en las semanas 12, 24 y 36 5. Cambio desde el inicio en los días de dolor de cabeza mensuales promediados durante las semanas 1-12 6. Cambio desde el inicio en los días de migraña mensuales promediados durante las semanas 1-12 7. Cambio desde el inicio en la tasa de migrañas con intensidad de dolor severo promediado durante las semanas 1-12 |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. Time Frame: Baseline, Weeks 8, 12, 24, 36, and 44 2. Time Frame: Baseline (Week 0), Weeks 8, 12, 24, 36, and 44 3. Time Frame: Baseline (Week 0), Weeks 8, 12, 24, 36, and 44 4. Time Frame: Baseline, Weeks 12, 24, and 36 5. Time Frame: Baseline, Weeks 1-12 6. Time Frame: Baseline, Weeks 1-12 7. Time Frame: Baseline, Weeks 1-12 |
1. Marco de tiempo: línea de base, semanas 8, 12, 24, 36 y 44 2. Marco de tiempo: línea de base (semana 0), semanas 8, 12, 24, 36 y 44 3. Marco de tiempo: línea de base (semana 0), semanas 8, 12, 24, 36 y 44 4. Marco de tiempo: línea de base, semanas 12, 24 y 36 5. Marco de tiempo: línea de base, semanas 1-12 6. Marco de tiempo: línea de base, semanas 1-12 7. Marco de tiempo: línea de base, semanas 1-12 |
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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 | Yes |
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) | Yes |
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 | 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 | 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 | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 16 |
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 |
Argentina |
Canada |
Mexico |
Serbia |
Turkey |
United States |
Italy |
Portugal |
United Kingdom |
Spain |
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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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The end of the study for an individual patient is defined as the last scheduled procedure shown in Panel 2. The overall end of the study is defined as the last scheduled procedure shown in Panel 2 for the last patient in the study globally. |
El final del estudio para un paciente individual se define como el último procedimiento programado que se muestra en el Panel 2. El final global del estudio se define como el último procedimiento programado que se muestra en el Panel 2 para el último paciente del estudio globalmente. |
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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 | 5 |
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 | 5 |
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 |