E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
High frequency episodic migraine |
Emicrania episodica ad alta frequenza |
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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 treatment benefit of erenumab on headache duration of at least moderate pain intensity. |
Valutare il beneficio terapeutico di erenumab sulla durata del dolore cefalico di intensità almeno moderata |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Age > = 18 years upon entry into initial screening • Documented history of migraine with or without aura according to the International Headache Society (IHS) International Classification of Headache Disorders, Third Edition (ICHD-III) for > = 12 months • Have HFEM: Defined as history of > = 7 and < 15 migraine days and < 15 headache days per month on average during the 3 months prior to screening • History of > = 4 migraine attacks of at least moderate severity per month on average during the 3 months prior to screening • History of treatment failure with at least 1 preventive treatment for migraine. Failure of preventive treatment for migraine is defined as treatment discontinuation due to lack of efficacy, adverse event, or general poor tolerability. • Regular user of an oral triptan (eletriptan, rizatriptan, sumatriptan, or zolmitriptan) for acute migraine treatment, and typically initiating acute treatment with an oral triptan on > 50% of attacks of at least moderate pain intensity. Regular use is defined as > = 4 days of oral triptan use per month during the 3 months prior to screening. |
- Età > = a 18 anni al momento dello screening iniziale - Anamnesi documentata di emicrania con o senza aura da > = 12 mesi in accordo alla classificazione della International Headache Society (IHS) (International Classification of Headache Disorders, Terza Edizione (ICHD-III)) - HFEM: definito come anamnesi di > = 7 e < 15 giorni di emicrania e < 15 giorni di cefalea al mese in media nei 3 mesi precedenti lo screening - Anamnesi > = 4 attacchi di emicrania al mese di intensità almeno moderata in media nei 3 mesi precedenti lo screening - Anamnesi di fallimento terapeutico con almeno un trattamento preventivo dell'emicrania. Il fallimento del trattamento preventivo è definito come interruzione in seguito a mancanza di efficacia, eventi avversi, o scarsa tollerabilità generale. - Uso regolare di un triptano per via orale (eletriptan, rizatriptan, sumatriptan o zolmitriptan) per il trattamento auto di emicrania e inizio in genere del trattamento acuto con un triptano per via orale nel > 50% degli attacchi con intensità del dolore almeno moderata. L'uso regolare è definito come > = 4 giorni di utilizzo al mese di triptano per via orale durante i 3 mesi precedenti lo screening. |
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E.4 | Principal exclusion criteria |
• History of hemiplegic migraine, cluster headache, or other trigeminal autonomic cephalalgia • Has any medical contraindication to the use of an oral triptan • Previously treated with any agent (monoclonal antibody or small molecule) targeting the calcitonin gene-related peptide (CGRP) pathway (ligand or receptor) in the preventive setting • Previously treated or currently being treated with lasmiditan in the acute setting • No therapeutic response with > 4 of the defined medication categories after an adequate therapeutic trial • Currently has a history of consistent excellent response to oral triptans, defined as achievement of pain-freedom in < = 1 hour for > = 50% of treated attacks of at least moderate pain intensity during the 3 months prior to screening • Use of triptans administered via a non-oral (eg, subcutaneous [SC] or intranasal delivery systems) or sublingual route at the time of screening, during the run-in and baseline periods, and throughout the study duration |
- Anamnesi di emicrania emiplegica, cefalea a grappolo o altra cefalalgia autonomico-trigeminale - Qualsiasi controindicazione medica all’utilizzo di un triptano per via orale - Trattamento pregresso con un agente (anticorpo monoclonale o piccola molecola) che ha come bersaglio la via (ligando o recettore) del peptide correlato al gene della calcitonina (CGRP) nel contesto del trattamento preventivo - Trattamento pregresso o in corso con lasmiditan nel contesto del trattamento acuto - Nessuna risposta terapeutica con >4 delle categorie terapeutiche definite dopo un adeguato studio clinico terapeutico - Attuale risposta eccellente e costante ai triptani per via orale, definita come il raggiungimento della libertà dal dolore in < = 1 ora per > = 50% degli attacchi trattati con dolore di intensità almeno moderata nei 3 mesi precedenti lo screening - Uso di triptani somministrati non per via orale (ad es. sottocutanea [sc] o sistemi di somministrazione intranasale) o per via sublinguale al momento dello screening, durante il periodo di run-in e basale e per tutta la durata dello studio |
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E.5 End points |
E.5.1 | Primary end point(s) |
Change from baseline in mean monthly hours of at least moderate headache pain intensity over months 1, 2, and 3 |
Variazione rispetto al basale delle ore medie mensili del dolore cefalico di intensità almeno moderata nel corso dei mesi 1, 2 e 3 |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Months 1, 2, and 3 |
Mesi 1, 2 e 3 |
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E.5.2 | Secondary end point(s) |
- Change from baseline in mean monthly function as measured by the Migraine Functional Impact Questionnaire (MFIQ) over months 1, 2, and 3: - Impact on physical functioning - Impact on usual activities - Impact on emotional functioning - Impact on social functioning - Change from baseline in mean monthly hours of at least moderate pain intensity per migraine attack over months 1, 2, and 3 - Change from baseline in mean monthly peak migraine pain intensity as assessed by the 11-point Numeric Rating Scale (NRS) over months 1, 2, and 3 |
• Variazione rispetto al basale della funzionalità media mensile misurata tramite il questionario MFIQ (Migraine Functional Impact Questionnaire) nel corso dei mesi 1, 2 e 3: - Impatto sulla funzionalità fisica - Impatto sulle attività abituali - Impatto sulla funzionalità emotiva - Impatto sulla funzionalità sociale • Variazione rispetto al basale delle ore medie mensili del dolore di intensità almeno moderata per attacco di emicrania nel corso dei mesi 1, 2 e 3 • Variazione rispetto al basale del dolore medio mensile emicranico di intensità massima valutato tramite la scala di valutazione numerica (NRS) a 11 punti nel corso dei mesi 1, 2 e 3 |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Months 1, 2, and 3 |
Mesi 1, 2 e 3 |
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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 | No |
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
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 | 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 | 40 |
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 |
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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
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | 28 |
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 |
E.8.9.2 | In all countries concerned by the trial days | 28 |