Phase 3
N=1,121
Evaluation of ALD403 (Eptinezumab) in the Prevention of Chronic Migraine
Migraine Disorders
Bottom Line
View on ClinicalTrials.gov: NCT02974153 ↗Enrolled (actual)
1,121
Serious AEs
0.9%
Results posted
Jun 2020
Primary outcome: Primary: Change From Baseline in Monthly Migraine Days — -8.2; -7.7; -5.6 Migraine Days — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- ALD403 (Eptinezumab) (Biological); Placebo (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alder Biopharmaceuticals, Inc.
- Primary completion
- Nov 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Monthly Migraine Days |
-8.2; -7.7; -5.6 | <0.0001 sig |
| SECONDARY 75% Migraine Responder Rate |
116; 95; 55 | <0.0001 sig |
| SECONDARY 75% Migraine Responder Rate - 4 Week |
129; 110; 57 | <0.0001 sig |
| SECONDARY 50% Migraine Responder Rate |
215; 205; 144 | <0.0001 sig |
| SECONDARY Percentage of Participants With a Migraine on the Day After Dosing |
27.8; 28.6; 42.3 | <0.0001 sig |
| SECONDARY Change in Monthly Acute Medication Days |
-3.5; -3.3; -1.9 | <0.0001 sig |
| SECONDARY Change From Baseline of Headache Impact Test (HIT-6) Score |
-7.3; -6.2; -4.5 | <0.0001 sig |
| SECONDARY Change in Migraine Prevalence From Baseline to Week 4 |
-29.8; -27.1; -18.8 | <0.0001 sig |
| SECONDARY 75% Headache Responder Rate |
61; 49; 29 | — |
| SECONDARY 50% Headache Responder Rate |
169; 150; 95 | — |
| SECONDARY 100% Migraine Responder Rate |
15.1; 10.8; 5.1 | — |
| SECONDARY 100% Headache Responder Rate |
3.8; 2.0; 1.5 | — |
| SECONDARY Change From Baseline in Monthly Migraine Days (Weeks 13-24) |
-9.0; -8.3; -6.4 | — |
| SECONDARY Change From Baseline in Monthly Headache Days (Weeks 1-12) |
-8.8; -8.2; -6.4 | — |
| SECONDARY Time to First Migraine After Dosing |
4.0; 4.0; 2.0 | — |
| SECONDARY Change From Baseline to Week 12 in Percentage of Migraines With Use of Acute Medication |
-14.10; -9.79; -2.82 | — |
| SECONDARY Change From Baseline to Week 12 in Percentage of Headaches With Use of Acute Medication |
-7.46; -3.08; -0.16 | — |
| SECONDARY Percent Change in Frequency of Migraine Days - Week 1-12 |
-53.5; -48.6; -34.5 | — |
| SECONDARY Percent Change in Frequency of Headache Days - Week 1-12 |
-44.1; -41.2; -31.4 | — |
| SECONDARY Change From Baseline in Percentage of Severe Migraines |
-18.17; -16.39; -10.82 | — |
| SECONDARY Change From Baseline in Percentage of Severe Headache |
-14.00; -14.01; -9.12 | — |
| SECONDARY Change From Baseline in Monthly Migraine Hours, Weeks 1-12 |
-80.9; -75.2; -52.8 | — |
| SECONDARY Change From Baseline in Monthly Headache Hours, Weeks 1-12 |
-82.5; -74.6; -54.8 | — |
| SECONDARY Duration of Migraine-Free Intervals |
132; 146; 226; 86; 95; 75 | — |
| SECONDARY Change From Baseline of Short Form Health Survey (SF-36 v 2.0) Scale Scores |
3.3; 2.6; 1.5; 6.0; 4.6; 3.6 | — |
| SECONDARY Patient Global Impression of Change (PGIC) at Week 12 |
73; 54; 38; 142; 126; 92 | — |
| SECONDARY Health Related Quality of Life (EQ-5D-5L) at Week 12 |
289; 289; 298; 41; 41; 37 | — |
Summary
The purpose of this study is to assess the efficacy and safety of ALD403 in the prevention of migraine headache in chronic migraineurs.
Eligibility Criteria
Inclusion Criteria
- Males and females between 18 and 65 years of age, inclusive, who were diagnosed with migraines at ≤ 50 years of age, and have a history of chronic migraine for ≥ 12 months before screening.
- During the 28 day screening period, subjects must adequately complete the headache eDiary and must have headaches occurring on ≥ 15 to ≤ 26 days of which at least 8 must be migraine days.
- Headache eDiary was completed on at least 24 of the 28 days prior to randomization.
Exclusion Criteria
- Confounding and clinically significant pain syndromes (e.g. fibromyalgia, chronic low back pain, complex regional pain syndrome).
- Psychiatric conditions that are uncontrolled and/or untreated, including conditions that are not controlled for a minimum of 6 months prior to screening. Patients with a lifetime history of psychosis, mania, or dementia are excluded.
- Any use of botulinum toxin for migraine or for any other medical/cosmetic reasons requiring injections within 4 months prior to screening and during the screening period.
- History or diagnosis of complicated migraine (ICHD-III beta version, 20134), chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, or sporadic and familial hemiplegic migraine.
- Receipt of any monoclonal antibody treatment (within or outside a clinical trial) within 6 months before screening.
- Previously dosed with ALD403 or any monoclonal antibody targeting the CGRP pathway.
Data sourced from ClinicalTrials.gov (NCT02974153). 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.