E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Prevention of migraine in patients with unsuccessful prior preventive treatments |
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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 | HLT |
E.1.2 | Classification code | 10027603 |
E.1.2 | Term | Migraine headaches |
E.1.2 | System Organ Class | 100000004852 |
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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 |
Researchers are trying to learn whether a drug called Lu AG09222 can help prevent migraine headaches for people who have not been helped by other treatments that are used to prevent migraines. People who join this trial have at least 8 days a month with a migraine. They have tried 2 to 4 other medications to prevent their migraines, but these medications have not helped them. When the trial is over, researchers will use this information to find out if the number of migraine days decreased more for the participants who got either dose of Lu AG09222 than for the participants who got the placebo.
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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 |
- The participant has a diagnosis of migraine as defined by International Classification of Headache Disorders Third Edition (ICHD-3) guidelines confirmed at the Screening Visit. - The participant has a history of migraine onset at least 12 months prior to the Screening Visit. - The participant has a migraine onset of ≤50 years of age. - The participant has ≥8 migraine days per month for each month within the past 3 months prior to the Screening Visit. - The participant fulfils the following criteria for migraine in prospectively collected information in the eDiary during the screening period: - Migraine occurring on ≥8 days and headache occurring on ≤26 days. - The participant has documented evidence of treatment failure in the past 10 years of at least 2 to 4 (maximum) different migraine preventive medications.
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E.4 | Principal exclusion criteria |
- The participant has been previously dosed with an anti-pituitary adenylate cyclase-activating polypeptide (anti-PACAP) ligand-targeting antibody. - The participant has confounding and clinically significant pain syndromes. - The participant has a diagnosis of acute or active temporomandibular disorder. - The participant has a history or diagnosis of confounding headaches.
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E.5 End points |
E.5.1 | Primary end point(s) |
1. Change From Baseline in the Number of Monthly Migraine Days (MMDs) at Month 1 (Weeks 1-4) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Time Frame: Baseline, Month 1 (Weeks 1-4) |
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E.5.2 | Secondary end point(s) |
1. Percentage of Participants With ≥50% Reduction From Baseline in MMDs 2. Change From Baseline in the Number of Monthly Headache Days (MHDs) at Month 1 (Weeks 1-4) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Secondary Endpoints: 1. Time Frame: Baseline up to Month 1 (Weeks 1-4) 2. Time Frame: Baseline, Month 1 (Weeks 1-4) |
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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 | Yes |
E.6.7 | Pharmacodynamic | Yes |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
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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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | 9 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 20 |
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 |
Georgia |
United States |
Denmark |
Poland |
Slovakia |
Czechia |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | 11 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
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 | 11 |