Phase 3
Completed N=898
A Multicenter Assessment of ALD403 in Frequent Episodic Migraine
Migraine Disorders
Source: ClinicalTrials.gov NCT02559895 ↗
Enrolled (actual)
898
Serious AEs
1.9%
Results posted
May 2020
Primary outcomePrimary: Change From Baseline in Monthly Migraine Days (Weeks 1-12) — -4.3; -3.9; -4.1; -3.1 Migraine Days — p=0.0001
◆ Published Evidence
Established
26citations · ~7 / year
Efficacy and safety of eptinezumab in patients with migraine and self-reported aura: Post hoc analysis of PROMISE-1 and PROMISE-2.
Summary
The purpose of this study is to assess ALD403 in the prevention of migraine headache in frequent episodic migraineurs.
Linked Publications (5)
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Efficacy and safety of eptinezumab in patients with migraine and self-reported aura: Post hoc analysis of PROMISE-1 and PROMISE-2.
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Impact of Baseline Characteristics on the Efficacy and Safety of Eptinezumab in Patients With Migraine: Subgroup Analyses of PROMISE-1 and PROMISE-2.
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Measuring dose-related efficacy of eptinezumab for migraine prevention: post hoc analysis of PROMISE-1 and PROMISE-2.
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Patient-reported outcomes, health-related quality of life, and acute medication use in patients with a ≥ 75% response to eptinezumab: subgroup pooled analysis of the PROMISE trials.
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Shift in diagnostic classification of migraine after initiation of preventive treatment with eptinezumab: post hoc analysis of the PROMISE studies.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Monthly Migraine Days (Weeks 1-12) |
-4.3; -3.9; -4.1; -3.1 | 0.0001 sig |
| SECONDARY 75% Migraine Responder Rate |
70; 68; 67; 45 | 0.0066 sig |
| SECONDARY 50% Migraine Responder Rate |
125; 110; 112; 83 | 0.0001 sig |
| SECONDARY Percentage of Participants With a Migraine on the Day After Dosing |
13.9; 14.8; 17.3; 22.5 | 0.0159 sig |
| SECONDARY 75% Headache Responder Rate |
42; 28; 34; 23 | — |
| SECONDARY 50% Headache Responder Rate |
113; 98; 98; 74 | — |
| SECONDARY 100% Migraine Responder Rate |
9; 1; 4; 4 | — |
| SECONDARY 100% Headache Responder Rate |
6; 0; 4; 2 | — |
| SECONDARY Change From Baseline in Acute Migraine Medication Days (Weeks 1-12) |
-0.8; -0.9; -0.6; -0.4 | — |
| SECONDARY Change From Baseline in Average Daily Migraine Prevalence to Week 4 |
-14.9; -13.8; -15.1; -9.7 | — |
| SECONDARY Change From Baseline to Week 12 in Percentage of Migraines With Use of Acute Medication |
62.08; 66.58; 69.11; 71.44 | — |
| SECONDARY Change From Baseline to Week 12 in Percentage of Headaches With Use of Acute Medication |
63.09; 66.85; 67.84; 70.95 | — |
| SECONDARY Change From Baseline in Monthly Headache Days (Weeks 1-12) |
-4.5; -4.0; -4.4; -3.3 | — |
| SECONDARY Percent of Headaches With Severe Intensity |
17.06; 19.84; 21.20; 21.68 | — |
| SECONDARY Percent of Migraines With Severe Intensity |
19.07; 22.23; 24.43; 26.01 | — |
| SECONDARY Change From Baseline in Monthly Migraine Hours (Weeks 1-12) |
-42.9; -35.3; -37.8; -23.8 | — |
| SECONDARY Change From Baseline in Monthly Headache Hours, Weeks 1-12 |
-42.0; -34.2; -38.8; -24.5 | — |
| SECONDARY Change From Baseline of Short Form Health Survey (SF-36 v 2.0) Scale Scores |
0.9; 1.2; 0.9; 0.3; 3.0; 2.3 | — |
| SECONDARY Health Related Quality of Life (EQ-5D-5L) at Week 12 |
183; 181; 181; 179; 21; 18 | — |
| SECONDARY Change in Baseline of Allodynia Symptom Checklist-12 (ASC-12) Total Score |
-1.6; -1.8; -1.6; -1.7 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of migraine at ≤ 50 years of age (ICHD-II, 2004 Section 1)
- History of migraine ≥ 12 months with
- ≤ 14 headache days of which at least 4 have to be migraine days (migraine days count as headache days) in each 28 day period in the 3 months prior to screening
- During the 28 days following the screening visit, the subject experiences ≤ 14 headache days of which at least 4 have to be migraine days (migraine days count as headache days) as recorded in the eDiary
- No use of any botulinum toxin for migraine or for any other medical/cosmetic reasons requiring injections in the head, face, or neck 4 months prior to screening and during the 28 day period prior to randomization
- Headache eDiary was completed on at least 25 of the 28 days prior to randomization
Exclusion Criteria
- Confounding pain syndromes, e.g. fibromyalgia, complex regional pain syndrome or any pain syndrome that requires regular analgesia
- Psychiatric conditions that are uncontrolled and untreated, including conditions that are not controlled for a minimum of 6 months prior to screening
- History or diagnosis of complicated migraine (ICHD- II, 2004 Section 1), chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, migraine with brainstem aura, sporadic and familial hemiplegic migraine
- Unable to differentiate migraine from other headaches
- Have any clinically significant concurrent medical condition
- Receipt of any monoclonal antibody treatment within 6 months of screening (within or outside a clinical trial)
- Previously dosed with ALD403 or any monoclonal antibody targeting the CGRP pathway
Data sourced from ClinicalTrials.gov (NCT02559895) 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.