Phase 3
Completed N=892
A Study to Evaluate the Efficacy and Safety of Eptinezumab for the Prevention of Migraine in Participants That Are Not Helped by Previous Preventive Treatments
Migraine
Source: ClinicalTrials.gov NCT04418765 ↗
Enrolled (actual)
892
Serious AEs
2.5%
Results posted
Jul 2022
Primary outcomePrimary: Change From Baseline in the Number of Monthly Migraine Days (MMDs) Averaged Over Weeks 1 to 12 — -2.1; -4.8; -5.3 days/month — p=<0.0001
◆ Published Evidence
Emerging
4citations · ~2 / year
Structural equation modeling for identifying the drivers of health-related quality of life improvement experienced by patients with migraine receiving eptinezumab.
Summary
Evaluation of eptinezumab in the prevention of migraine in participants with unsuccessful prior preventive treatments.
Linked Publications (5)
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Structural equation modeling for identifying the drivers of health-related quality of life improvement experienced by patients with migraine receiving eptinezumab.
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Impact of eptinezumab on work productivity beyond reductions in monthly migraine days: post hoc analysis of the DELIVER trial.
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Early and Sustained Shift in Headache Day Frequency Following Eptinezumab Treatment in Adults With Migraine for Whom 2-4 Previous Preventive Treatments Have Failed: A Post Hoc Analysis of the Randomized DELIVER Trial.
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Long-Term Improvements Following Initial Migraine Response in Eptinezumab-Treated Participants With Migraine for Whom 2-4 Prior Preventive Treatments Have Failed.
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Sustained Efficacy of Eptinezumab in Participants with Migraine for Whom Prior Preventive Treatments Failed and Who Self-reported Psychiatric Comorbidities: Post Hoc Analysis of the Placebo-controlled DELIVER Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Number of Monthly Migraine Days (MMDs) Averaged Over Weeks 1 to 12 |
-2.1; -4.8; -5.3 | <0.0001 sig |
| SECONDARY Percentage of Participants With ≥50% Reduction From Baseline in MMDs Averaged Over Weeks 1 to 12 |
13.1; 42.1; 49.5 | <0.0001 sig |
| SECONDARY Change From Baseline in the Number of MMDs Averaged Over Weeks 13 to 24 |
-2.4; -5.4; -6.1 | <0.0001 sig |
| SECONDARY Percentage of Participants With ≥75% Reduction From Baseline in MMDs Averaged Over Weeks 1 to 12 |
2.0; 15.7; 18.8 | <0.0001 sig |
| SECONDARY Change From Baseline in the Headache Impact Test (HIT-6) Score at Week 12 |
-3.1; -6.9; -8.5 | <0.0001 sig |
| SECONDARY Percentage of Participants With ≥50% Reduction From Baseline in MMDs Averaged Over Weeks 13 to 24 |
23.7; 52.3; 59.1 | — |
| SECONDARY Percentage of Participants With ≥75% Reduction From Baseline in MMDs Averaged Over Weeks 13 to 24 |
6.8; 21.3; 27.6 | — |
| SECONDARY Percentage of Participants With 100% Reduction From Baseline in MMDs Averaged Over Weeks 1 to 12 |
1.1; 5.9; 7.7 | — |
| SECONDARY Percentage of Participants With ≥50% Reduction From Baseline in Monthly Headache Days (MHDs) Averaged Over Weeks 1 to 12 |
12.8; 39.5; 45.7 | — |
| SECONDARY Percentage of Participants With ≥75% Reduction From Baseline in Monthly Headache Days (MHDs) Averaged Over Weeks 1 to 12 |
2.3; 15.1; 16.4 | — |
| SECONDARY Percentage of Participants With 100% Reduction From Baseline in Monthly Headache Days (MHDs) Averaged Over Weeks 1 to 12 |
1.1; 4.1; 5.3 | — |
| SECONDARY Change From Baseline in the Number of MHDs Averaged Over Weeks 1 to 12 |
-2.1; -4.6; -5.1 | — |
| SECONDARY Change From Baseline in the Percentage of Migraine Attacks With Severe Pain Intensity Averaged Over Weeks 1 to 12 |
-10.2; -17.9; -21.3 | — |
| SECONDARY Change From Baseline in the Percentage of Headache Episodes With Severe Pain Intensity Averaged Over Weeks 1 to 12 |
-8.8; -16.2; -19.5 | — |
| SECONDARY Change From Baseline in the Number of Monthly Days With Use of Acute Migraine Medication Averaged Over Weeks 1 to 12 |
-1.6; -4.1; -4.6 | — |
| SECONDARY Change From Baseline in the Number of Monthly Days With Use of Acute Migraine Medication Averaged Over Weeks 13 to 24 |
-1.7; -4.6; -5.2 | — |
| SECONDARY Change From Baseline in the Number of MMDs With Use of Acute Medication Averaged Over Weeks 1 to 12 |
-2.0; -4.6; -5.2 | — |
| SECONDARY Change From Baseline in the Number of MMDs With Use of Acute Medication Averaged Over Weeks 13 to 24 |
-2.1; -4.9; -5.8 | — |
| SECONDARY Patient Global Impression of Change (PGIC) Score at Week 12 |
3.6; 2.6; 2.5 | — |
| SECONDARY PGIC Score at Week 24 |
3.5; 2.5; 2.4 | — |
| SECONDARY Change From Baseline in the Number of MMDs in Participants With Medication Overuse Headache (MOH) Averaged Over Weeks 1 to 12 |
-2.3; -5.6; -7.3 | — |
| SECONDARY Percentage of Participants With Migraine on the Day After First Dosing |
43.7; 27.2; 24.4 | — |
| SECONDARY Most Bothersome Symptom (MBS) Score at Week 12 |
3.7; 2.8; 2.7 | — |
| SECONDARY Change From Baseline in the HIT-6 Score at Week 24 |
-3.9; -8.9; -9.9 | — |
| SECONDARY Change From Baseline in the Migraine-Specific Quality of Life (MSQ) Subscores (Role Function-Restrictive, Role Function-Preventive, Emotional Function) at Week 12 |
13.7; 25.0; 28.7; 11.6; 22.7; 25.0 | — |
| SECONDARY Change From Baseline in the Health-Related Quality of Life (EQ-5D-5L) Visual Analog Scale (VAS) Score at Week 12 |
-3.1; 2.0; 4.4 | — |
| SECONDARY Change From Baseline in the MSQ Subscores (Role Function-Restrictive, Role Function-Preventive, Emotional Function) at Week 24 |
15.0; 30.1; 30.0; 13.1; 25.7; 26.3 | — |
| SECONDARY Change From Baseline in the Health-Related Quality of Life (EQ-5D-5L) VAS Score at Week 24 |
-2.8; 2.0; 5.2 | — |
| SECONDARY Change From Baseline in the Work Productivity and Activity Impairment (WPAI) Questionnaire Subscores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Week 12 |
-0.1; -5.8; -3.8; -9.9; -19.0; -23.3 | — |
| SECONDARY Change From Baseline in the WPAI Questionnaire Subscores (Absenteeism, Presenteeism, Work Productivity Loss, Activity Impairment) at Week 24 |
-0.7; -5.2; -5.4; -7.5; -22.2; -19.3 | — |
| SECONDARY Percentage of Participants With ≥5-Point Reduction From Baseline to Week 12 in HIT-6 Score |
39.9; 62.1; 62.0 | — |
| SECONDARY Percentage of Participants With ≥5-Point Reduction From Baseline to Week 24 in HIT-6 Score |
46.2; 72.1; 71.6 | — |
| SECONDARY Health Care Resource Utilization (HCRU): Visits to a Family Doctor/General Practitioner |
244; 259; 256; 35; 22; 22 | — |
| SECONDARY HCRU: Visits to a Specialist |
249; 256; 257; 33; 31; 24 | — |
| SECONDARY HCRU: Number of Emergency Department Visits Due to Your Migraine |
289; 289; 285; 6; 1; 3 | — |
| SECONDARY HCRU: Number of Hospital Admissions Due to Migraine |
295; 289; 287; 1; 1; 2 | — |
| SECONDARY HCRU: Total Number of Overnight Hospital Stays Due to Migraine |
295; 290; 289; 1; 0; 0 | — |
| SECONDARY Change From Baseline in the Number of MMDs Averaged Over Weeks 25 to 36, 37 to 48, 49 to 60, and 61 to 72 |
-4.7; -6.1; -5.8; -5.9; -5.0; -6.0 | — |
| SECONDARY Percentage of Participants With ≥50% Reduction From Baseline in MMDs Averaged Over Weeks 25 to 36, 37 to 48, 49 to 60, and 61 to 72 |
48.6; 63.0; 59.6; 61.0; 49.3; 60.3 | — |
| SECONDARY Percentage of Participants With ≥75% Reduction From Baseline in MMDs Averaged Over Weeks 25 to 36, 37 to 48, 49 to 60, and 61 to 72 |
19.4; 28.1; 25.9; 31.2; 27.9; 30.8 | — |
| SECONDARY Change From Baseline in HIT-6 Score at Weeks 36, 48, 60, and 72 |
-10.01; -12.15; -10.99; -12.0; -10.71; -12.71 | — |
Eligibility Criteria
Inclusion Criteria
- The participant has a diagnosis of migraine, with a history of chronic or episodic migraines of at least 12 months prior to the Screening Visit
- The participant has a migraine onset of ≤50 years of age.
- The participant has ≥4 migraine days per month for each month within the past 3 months prior to the Screening Visit.
- 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 fulfils the following criteria for chronic migraine (CM) or episodic migraine (EM) in prospectively collected information in the eDiary during the screening period:
- For participants with CM: Migraine occurring on ≥8 days and headache occurring on >14 days
- For participants with EM: Migraine occurring on ≥4 days and headache occurring on ≤14 days
- The participant has documented evidence of treatment failure (must be supported by medical record or by physician's confirmation specific to each treatment) in the past 10 years of 2-4 different migraine preventive medications.
- The participant has a history of either previous or active use of triptans for migraine.
Exclusion Criteria
- The participant has experienced failure on a previous treatment targeting the calcitonin gene-related peptide (CGRP) pathway.
- The participant has a treatment failure on valproate/divalproex or botulinum toxin A/B and the treatment is not the latest preventive medication prior to study inclusion. The medication is regarded as the latest if the medication start date is after the start date of the other preventive medications and the medication stop date is after the stop date of the other preventive medications.
- 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, and migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or long duration).
- The participant has a psychiatric condition that is uncontrolled and/or untreated for a minimum of 6 months prior to the Screening Visit. Participants with a lifetime history of psychosis and/or mania in the last 5 years prior to the Screening Visit are excluded.
- The participant has a history of clinically significant cardiovascular disease or vascular ischaemia or thromboembolic events (for example, cerebrovascular accident, deep vein thrombosis, or pulmonary embolism).
Other in- and exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT04418765) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.