E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Migraine and medication overuse headache |
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E.1.1.1 | Medical condition in easily understood language |
Migraine and medication overuse headache |
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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.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10072720 |
E.1.2 | Term | Medication overuse headache |
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 efficacy of eptinezumab as addition to BI for the prevention of migraine and treatment of MOH |
|
E.2.2 | Secondary objectives of the trial |
- To evaluate the efficacy of eptinezumab as add-on to BI on health-related quality of life and work productivity - To evaluate the efficacy of eptinezumab during the 12-week open-label extension period |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- The patient has a diagnosis of CM as defined by IHS ICHD-3 guidelines confirmed at the Screening Visit. - The patient has a history of migraine onset of at least 12 months prior to the Screening Visit. - The patient has ≥8 migraine days per month for each month within the past 3 months prior to the Screening Visit. - The patient has a diagnosis of MOH as defined by IHS ICHD-3 guidelinesconfirmed at the Screening Visit. - The patient has ≥15 headache daysper monthfor each month within the past 3 months prior to the Screening Visit. - The patient has regular overuse of one or more drugs that can be taken for acute treatment of headache, for >3 monthsprior to the Screening Visit. - The patient has ≥15 to ≤26 headache days, of which ≥8 days were assessed as migraine days during the screening period, based on prospectively collected information in the eDiary. - The patient overuses drugs that can be taken for acute treatment of headacheduring the screening period, based on prospectively collected information in the eDiary. - The patient has a history of treatment failure with at least 1 preventive treatment within the last 5 years prior to the Screening Visitdue to lack of efficacy (no clinically meaningful improvement at the locally recommended dose for at least 3 months). - The patient has demonstrated compliance with the Headache eDiary by entry of data for at least 24 of the 28 days following the Screening Visit. - The patient has had an onset of migrainediagnosisat <50 years of age. - The patient is aged ≥18 and ≤75years at the Screening Visit. |
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E.4 | Principal exclusion criteria |
- The patient has experienced failure on a previous preventive treatment targeting the CGRP pathwayincluding gepants for acute or preventive use. - The patient has confounding and clinically significant pain syndromes (for example, fibromyalgia, chronic low back pain, and complex regional pain syndrome). - The patient has a diagnosis of acute or active temporomandibular disorders. - The patient has a history or diagnosis of chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, or unusual migraine subtypes such as hemiplegic migraine (sporadic and familial), recurrent painful ophthalmoplegic neuropathy, migraine with brainstem aura and migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or long duration). - The patient has psychosis, bipolar mania, dementia, or any other psychiatric conditions whose symptoms are not controlled or who has not been adequately treated for a minimum of 6months prior to the Screening Visit. - The patient has a history of clinically significant cardiovascular disease, including uncontrolled hypertension, vascular ischaemia, or thromboembolic events (for example, cerebrovascular accident, deep vein thrombosis, or pulmonary embolism). |
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E.5 End points |
E.5.1 | Primary end point(s) |
- Change from baseline in the number of MMDs |
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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 MMDs - Change from baseline in the number of MHDs - Change from baseline in MHDs - Not fulfilling the ICHD-3 diagnostic criteria for CM nor MOH - Not fulfilling the ICHD-3 diagnostic criteria for CM nor MOH - Change from baseline in average Daily Pain assessment score - Change from baseline in monthly days with acute medication use - Change from baseline in monthly days with acute medication use
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
- Change from baseline in MMDs (Weeks 1-12) - Change from baseline in the number of MHDs (Weeks 1-4) - Change from baseline in MHDs (Weeks 1-12) - Not fulfilling the ICHD-3 diagnostic criteria for CM nor MOH (Week 4) - Not fulfilling the ICHD-3 diagnostic criteria for CM nor MOH (Week 12) - Change from baseline in average Daily Pain assessment score (Weeks 1-2) - Change from baseline in monthly days with acute medication use (Weeks 1-4) - Change from baseline in monthly days with acute medication use (Weeks 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 | 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) | 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 | 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 | 1 |
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 | 11 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 58 |
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 |
United States |
Denmark |
Norway |
Netherlands |
Spain |
Germany |
Italy |
|
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 | 1 |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |