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 |
To find out if eptinezumab is better than placebo (normal saline solution) in lowering the number of days with migraine in young people ages 12 to 17 with chronic migraine. |
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E.2.2 | Secondary objectives of the trial |
To evaluate the population pharmacokinetics and immunogenicity of eptinezumab administered IV to patients 12 to 17 years of age with CM |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- The participant has a diagnosis of migraine (with or without aura) as defined by International Classification of Headache Disorders 3 (ICHD-3) guidelines with history of chronic migraine, of at least 6 months prior to the screening visit.
- During the 28-day screening period, the participant must adequately complete the headache eDiary on at least 24 of the 28 days following the screening visit.
- During the 28-day screening period, the participant must have ≥15 to ≤26 headache days, of which at least 8 are migraine days as documented in the eDiary.
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E.4 | Principal exclusion criteria |
- The participant has previously been enrolled in this study and exposed to eptinezumab.
- The participant has been exposed to any monoclonal antibody treatment (including exposure in a study) <6 months prior to the screening visit.
- The participant has been exposed to another calcitonin gene-related peptide (CGRP) antibody (including exposure in a study investigating a CGRP antibody) <6 months prior to the screening visit.
- The participant has a history or diagnosis of complicated migraine (ICHD-3 version, 2018), 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), migraine with brainstem aura, ophthalmoplegic migraine, or migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or long duration).
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E.5 End points |
E.5.1 | Primary end point(s) |
1. Change From Baseline in Monthly Migraine Days (MMDs) Averaged Over Weeks 1-12
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
1. Time Frame: Baseline, Weeks 1-12
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E.5.2 | Secondary end point(s) |
1. Percentage of Participants With 50% Reduction From Baseline in MMDs Averaged Over Weeks 1-12
2. Percentage of Participants With Migraine on the Day After Dosing (Day 1)
3. Change From Baseline in MMDs With Use of Acute Medication Averaged Over Weeks 1-12
4. Percentage of Participants With 75% Reduction From Baseline in MMDs Averaged Over Weeks 1-12
5. Percentage of Participants With 75% Reduction From Baseline in MMDs Averaged Over Weeks 1-4
6. Percentage of Participants With 50% Reduction From Baseline in MMDs Averaged Over Weeks 1-4
7. Change From Baseline in Monthly Headache Days Averaged Over Weeks 1-12
8. Change From Baseline in Rate of Migraines With Severe Pain Intensity Averaged Over Weeks 1-12
9. Change From Baseline in Days With Use of Acute Medication Averaged Over Weeks 1-12
10. Change From Baseline in Pediatric Migraine Disability Assessment Questionnaire (PedMIDAS) Score Averaged Over Weeks 1-12
11. Free Eptinezumab Plasma Concentration
12. Number of Participants With Specific Anti-Eptinezumab Antibodies (Anti-Drug Antibodies [ADA])
13. Number of Participants With Specific Anti-Eptinezumab Antibodies for Neutralizing Activity (NAb) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. Time Frame: Baseline up to Weeks 1-12 2. Time Frame: Day 1 3. Time Frame: Baseline, Weeks 1-12 4. Time Frame: Baseline up to Weeks 1- 12 5. Time Frame: Baseline up to Weeks 1-4 6. Time Frame: Baseline up to Weeks 1-4 7. Time Frame: Baseline, Weeks 1-12 8. Time Frame: Baseline, Weeks 1-12 9. Time Frame: Baseline, Weeks 1-12 10. Time Frame: Baseline, Weeks 1-12 11. Time Frame: Randomization ( pre-dose [Week 0]), Week 8, Week 12, and safety follow up visit (Week 20) 12. Time Frame: From randomization (Week 0) up to Week 20 13. Time Frame: From randomization (Week 0) up to Week 20 |
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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 | 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 | 3 |
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 |
United States |
Spain |
Italy |
Portugal |
Serbia |
Turkey |
United Kingdom |
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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 of the protocol. The overall end of the study is defined as the last scheduled procedure shown in Panel 2 of the protocol for the last patient in the study globally. |
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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 | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 4 |
E.8.9.2 | In all countries concerned by the trial days | 0 |