Eptinezumab as Preventive Treatment of Migraine in Adults With Migraine

Study Overview
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Brief Summary
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This study evaluates the efficacy of eptinezumab to prevent migraine in participants with chronic migraine.

Detailed Description
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This is an interventional, multi-regional, multi-site, randomized, double-blind, placebo-controlled Phase III study, to confirm the efficacy and safety of eptinezumab in participants with chronic migraine who are eligible for preventive treatment. participants will be randomly allocated to one of three treatment groups: eptinezumab 300 mg, eptinezumab 100 mg, or placebo. The double-blind, placebo-controlled treatment period will be followed by an extension period where all participants will receive active treatment to further assess the safety and tolerability of eptinezumab. The total study duration from the Screening Visit to the Safety Follow-up Visit is approximately 36 weeks and includes a Screening Period (28-30 days), a Placebo-controlled Period (12 weeks), an Extension Period (12 weeks), and a Safety Follow-up Period (8 weeks).

Official Title
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Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate Efficacy and Safety of Eptinezumab for the Preventive Treatment of Migraine

Conditions
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Migraine

Intervention / Treatment
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* Drug: Placebo
* Drug: Eptinezumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The participant has a diagnosis of CM as defined by IHS ICHD-3 guidelines confirmed at screening visit with a history of migraine onset at least 12 months prior to the Screening Visit. The participant has a migraine onset at ≤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 ≥15 to ≤26 days. The participant has demonstrated compliance with the Headache eDiary by entry of data for at least 24 of the 28 days following the Screening Visit. The participant is aged ≥18 (≥20 for Taiwan) and ≤75 years at the Screening Visit. Exclusion Criteria: The participant has received any medication targeting the calcitonin gene-related peptide (CGRP) pathway as preventive treatment of migraine. The participant has confounding and clinically significant pain syndromes, (for example, fibromyalgia, chronic low back pain, complex regional pain syndrome). The participant has a diagnosis of acute or active temporomandibular disorder. The participant 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), ophthalmoplegic migraine, migraine with brainstem aura and migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or long duration). The participant has a lifetime history of psychosis, bipolar mania, or dementia. Participants with other psychiatric conditions whose symptoms are not controlled or who have not been adequately treated for a minimum of 6 months prior to screening are also excluded. The participant 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). Other inclusion and exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Eptinezumab 300 mg<br>300 mg eptinezumab by intravenous (IV) infusion. | Drug: Eptinezumab<br>* Solution for infusion, intravenously<br>* Other names: Lu AG09221;|
| Experimental: Eptinezumab 100 mg<br>100 mg eptinezumab by IV infusion. | Drug: Eptinezumab<br>* Solution for infusion, intravenously<br>* Other names: Lu AG09221;|
| Placebo Comparator: Placebo<br>Placebo by IV infusion. | Drug: Placebo<br>* 0.9% normal saline, intravenously<br>Drug: Eptinezumab<br>* Solution for infusion, intravenously<br>* Other names: Lu AG09221;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the number of monthly migraine days (MMDs) (Weeks 1-12) |  | Weeks 1-12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response: ≥50% reduction from baseline in MMDs (Weeks 1-12) |  | Weeks 1-12 | 
| Response: ≥75% reduction from baseline in MMDs (Weeks 1-4) |  | Weeks 1-4 | 
| Response: ≥75% reduction from baseline in MMDs, (Weeks 1-12) |  | Weeks 1-12 | 
| Migraine rate on the day after dosing |  | Day 1 | 
| Response: ≥50% reduction from baseline in monthly headache days (MHDs) (Weeks 1-12) |  | Weeks 1-12 | 
| Change from baseline in the number of MHDs (Weeks 1-12) |  | Weeks 1-12 | 
| Response: ≥75% reduction from baseline in MHDs (Weeks 1-4) |  | Weeks 1-4 | 
| Change from baseline in rate of migraines with severe pain intensity (Weeks 1-12) |  | Weeks 1-12 | 
| Change from baseline in rate of headaches with severe pain intensity (Weeks 1-12) |  | Weeks 1-12 | 
| Change from baseline in the number of MMDs with use of acute medication (Weeks 1-12) |  | Weeks 1-12 | 
| Patient Global Impression of Change (PGIC) score at week 12 |  | Week 12 | 
| Most Bothersome Symptom (MBS) score at Week 12, as measured relative to Screening |  | Screening to Week 12 | 
| Change from baseline to Week 12 in the Headache Impact Test (HIT-6) score |  | Baseline to Week 12 | 
| Change from baseline to Week 12 in the Migraine-Specific Quality of Life (MSQ v2.1) sub-scores (Role Function-Restrictive, Role Function-Preventive, Emotional Function) |  | Baseline to Week 12 | 
| Change from baseline to Week 12 in the Health-Related Quality of Life (EQ-5D-5L) Visual Analogue Scale (VAS) score |  | Baseline to Week 12 | 
| Health Care Resources Utilization (HCRU) | Migraine-specific healthcare resource utilization information will be collected in terms of outpatient health care professional visits, emergency room visits, hospital admissions, as well as duration of hospital stays. | Baseline to Week 12 | 
| Change from baseline to Week 12 in the Work Productivity and Activity Impairment Questionnaire: Migraine (WPAI:M) sub-scores (Absenteeism, Presenteeism, Work productivity loss, Activity impairment) |  | Baseline to Week 12 |