E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
High frequency episodic migraine |
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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. |
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E.2.2 | Secondary objectives of the trial |
To evaluate the treatment benefit of erenumab on functional impairment. To evaluate the treatment benefit of erenumab on duration of migraine pain of at least moderate intensity. To evaluate the treatment benefit of erenumab on peak migraine pain intensity. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Key inclusion criteria include: ¿ 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. |
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E.4 | Principal exclusion criteria |
Key exclusion criteria include: ¿ 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 |
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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 |
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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 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 |
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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 | 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 | 4 |
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 | 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 |
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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 |