E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Episodic migraine |
emicrania episodica |
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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 |
To evaluate the effect of erenumab compared with placebo on the change in monthly migraine days (MMDs) from baseline to week 9 through week 12 (month 3) of the double-blind treatment phase (DBTP). |
Valutare l’effetto di erenumab rispetto al placebo sulla variazione in termini di giorni di emicrania mensile dal basale tra la settimana 9 - settimana 12 (mese 3) della fase di trattamento in doppio cieco e la fase di trattamento (DBTP). |
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E.2.2 | Secondary objectives of the trial |
- To evaluate the effect of erenumab compared with placebo on the change in monthly headache days from baseline to week 9 through week 12 of the DBTP. - To evaluate the effect of erenumab compared with placebo on the proportion of subjects with at least 50% reduction in MMDs from baseline to week 9 through week 12 of the DBTP. - To evaluate the effect of erenumab compared with placebo on change in MMDs from baseline to the average of the first 3 months of the DBTP. - To evaluate the effect of erenumab compared with placebo on change in MMDs from baseline to the average of the 6-month DBTP. - To evaluate the effect of erenumab compared with placebo on change in monthly average severity of migraine attacks from baseline to week 9 through week 12 of the DBTP. - To evaluate the effect of erenumab compared with placebo on change in migraine-related disability and productivity as measured by the modified Pediatric Migraine Disability Assessment from baseline to month 3 of the DBTP |
- Valutare l’effetto di erenumab rispetto al placebo sulla variazione dei giorni di cefalea mensile dal basale alle settimane 9-12 del DBTP. - Valutare l’effetto di erenumab rispetto al placebo sulla percentuale di soggetti con una riduzione di almeno il 50% degli MMD dal basale alle settimane 9-12 del DBTP. - Valutare l’effetto di erenumab rispetto al placebo sulla variazione degli MMD dal basale alla media dei primi 3 mesi della DBTP. - Valutare l’effetto di erenumab rispetto al placebo sulla variazione degli MMD dal basale alla media della DBTP di 6 mesi. - Valutare l’effetto di erenumab rispetto al placebo sulla variazione della gravità media mensile degli attacchi di emicrania dal basale alle settimane 9-12 della DBTP. - Valutare l’effetto di erenumab rispetto al placebo sulla variazione della disabilità correlata all’emicrania e sulla produttività misurata tramite il questionario PedMIDAS modificato dal basale al mese 3 della DBTP. |
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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 types of substudies Specify title, date and version of each substudy with relative objectives: 40-week optional dose-level-blinded extension phase (DLBEP), during which all subjects will receive erenumab at the blinded dose level.
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Altre tipologie di sottostudi specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Fase di estensione facoltativa in cieco rispetto alla dose (Dose-Level-Blinded Extension Phase, DLBEP) della durata di 40 settimane, durante la quale tutti i soggetti riceveranno erenumab in cieco rispetto alla dose
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E.3 | Principal inclusion criteria |
- Children (6 to < 12 years of age) or adolescent (12 to < 18 years of age) at the time of signing, if developmentally appropriate, the formal assent to participate to the study. - Subject's parent or legal representative has provided written informed consent before initiation of any study-specific activities/procedures. - History of migraine (with or without aura) for > = 12 months before screening according to the IHS Classification ICHD-3 based on medical records and/or subject self-report or parents' or legal representative's report. - History of < 15 headache days per month of which > = 4 headache days were assessed by the subject as migraine days per month in each of the 3 months prior to screening. - Migraine frequency: > = 4 and < 15 migraine days during the baseline phase based on the eDiary calculations. - Headache frequency: < 15 headache days during the baseline phase based on the eDiary calculations. - Demonstrated at least 80% compliance with the eDiary |
- Bambini (di età compresa tra 6 e <12 anni) e adolescenti (di età compresa tra 12 e <18 anni), se idoneo all'età dello sviluppo, al momento della firma dell'assenso formale per partecipare allo studio - Il genitore o il legale rappresentante del paziente ha fornito il consenso informato scritto prima dell'inizio di qualsiasi studio-attività/procedura specifica - Anamnesi di emicrania (con o senza aura) per >= 12 mesi prima dello screening in accordo con la IHS Classification ICHD-3 basata sulle cartelle mediche e/o autosegnalate dai pazienti o dai genitori o dal legale rappresentante - Anamnesi di giorni di cefalea < a 15 al mese, di cui > = 4 valutati dal soggetto come giorni di emicrania al mese nei 3 mesi precedenti lo screening - Frequenza di emicrania: > = 4 e < 15 giorni di emicrania durante la fase basale in base al calcolo dell'eDiary - Frequenza di cefalea: < 15 giorni di cefalea durante la fase basale in base al calcolo dell'eDiary - Compliance effettiva all'eDiary pari ad almeno 80% |
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E.4 | Principal exclusion criteria |
- History of cluster headache or hemiplegic migraine headache. - No therapeutic response with > 2 of the following 10 medication categories for prophylactic treatment of migraine after an adequate therapeutic trial - Malignancy within 5 years before screening. - History of suicidal behavior or the subject is at risk of self-harm or harm to others as evidenced by endorsement of items 4 or 5 on the pediatric Columbia-suicide Severity Rating Scale (C-SSRS) assessed at screening - Evidence of drug or alcohol abuse or dependence within 12 months before screening, based on medical records, subject self-report, or positive urine drug test performed during screening
*Please, refers to protocol for the full list |
- Anamnesi di cefalea a grappolo o emicrania emiplegica - Nessuna risposta terapeutica con > 2 delle seguenti 10 categorie di farmaci per il trattamento profilattico dell'emicrania dopo un adeguato trattamento terapeutico - Malignità entro 5 anni prima dello screening - Storia di comportamento suicidario o rischio di autolesionismo o danno ad altri come dimostrato dall'approvazione degli articoli 4 o 5 della Columbia-suicide Severity Rating Scale (C-SSRS) valutata al momento dello screening - Prove di abuso o dipendenza da droghe o alcol nei 12 mesi precedenti lo screening, sulla base di cartelle cliniche, referto autonomo o urine positive durante lo screening
*Fare riferimento al protocollo per l'elenco completo |
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E.5 End points |
E.5.1 | Primary end point(s) |
Change from baseline in MMDs to week 9 through week 12 (month 3) of the DBTP. |
Variazione degli MMD dal basale alle settimane 9-12 (mese 3) della DBTP. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
- Change from baseline in monthly headache days to week 9 through week 12 (month 3) of the DBTP - Achievement of at least 50% reduction in MMDs from baseline to week 9 through week 12 (month 3) of the DBTP. - Change from baseline in MMDs to the average of the first 3 months (week 1 through week 12) of the DBTP. - Change from baseline in MMDs to the average of the 6-month DBTP (week 1 through week 24). - Change from baseline in average monthly severity of migraine attacks to week 9 through week 12 (month 3) of the DBTP. - Change from baseline in migraine-related disability and productivity as measured by the modified PedMIDAS to month 3 of the DBTP. |
- Variazione dei giorni di cefalea mensili dal basale alle settimane 9-12 (mese 3) della DBTP. - Raggiungimento di una riduzione di almeno il 50% degli MMD dal basale alle settimane 9-12 (mese 3) della DBTP. - Variazione degli MMD dal basale alla media dei primi 3 mesi (settimane 1-12) della DBTP. - Variazione degli MMD dal basale alla media della DBTP di 6 mesi (settimane 1-24) - Variazione della gravità media mensile degli attacchi di emicrania dal basale alle settimane 9-12 (mese 3) della DBTP. - Variazione della disabilità correlata all’emicrania e alla produttività misurata tramite il PedMIDAS modificato dal basale al mese 3 della DBTP. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | 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) | 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 | 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 | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 4 |
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 | 32 |
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 | Information not present in EudraCT |
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 |
Belgium |
Canada |
Colombia |
Finland |
Germany |
Hungary |
Poland |
Russian Federation |
Switzerland |
United States |
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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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 3 |
E.8.9.2 | In all countries concerned by the trial days | 0 |