Phase 3
Completed N=577
Study to Evaluate the Efficacy and Safety of Erenumab (AMG 334) Compared to Placebo in Migraine Prevention
Source: ClinicalTrials.gov NCT02483585 ↗Enrolled (actual)
577
Serious AEs
2.1%
Results posted
Jun 2018
Primary outcomePrimary: Change From Baseline in Monthly Migraine Days at Week 12 — -1.84; -2.88 migraine days / month — p=< 0.001
◆ Published Evidence
Established
96citations · ~16 / year
Vascular safety of erenumab for migraine prevention.
Summary
To evaluate the effect of erenumab compared to placebo on the change from baseline in monthly migraine days, in adults with episodic migraine.
Linked Publications (5)
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Vascular safety of erenumab for migraine prevention.
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Assessment of Erenumab Safety and Efficacy in Patients With Migraine With and Without Aura: A Secondary Analysis of Randomized Clinical Trials.
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Safety and tolerability of erenumab in individuals with episodic or chronic migraine across age groups: a pooled analysis of placebo-controlled trials.
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Immunogenicity of erenumab: A pooled analysis of six placebo-controlled trials with long-term extensions.
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Reducing the physical, social, and emotional impact of episodic migraine: Results from erenumab STRIVE and ARISE phase III randomized trials.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Monthly Migraine Days at Week 12 |
-1.84; -2.88 | < 0.001 sig |
| SECONDARY Percentage of Participants With at Least a 50% Reduction From Baseline in Monthly Migraine Days at Week 12 |
29.5; 39.7 | 0.010 sig |
| SECONDARY Change From Baseline in Monthly Acute Migraine-specific Medication Treatment Days at Week 12 |
-0.62; -1.21 | 0.002 sig |
| SECONDARY Percentage of Participants With at Least a 5-point Reduction From Baseline in Average Impact on Everyday Activities Domain Score Measured by MPFID at Week 12 |
35.8; 40.4 | 0.26 |
| SECONDARY Percentage of Participants With at Least a 5-Point Reduction From Baseline in Average Impact on Physical Impairment Domain Score Measured by MPFID at Week 12 |
27.1; 33.0 | 0.13 |
| SECONDARY Number of Participants With Adverse Events |
158; 136; 337; 96; 72; 245 | — |
| SECONDARY Number of Participants Who Developed Antibodies to Erenumab |
25; 24; 10; 11; 0; 2 | — |
Eligibility Criteria
Inclusion Criteria
- History of migraines (with or without aura) for ≥ 12 months
- Migraine frequency: ≥ 4 and 2 categories for prophylactic treatment of migraine after an adequate therapeutic trial.
- Concomitant use of 2 or more medications with possible migraine prophylactic effects within 2 months prior to the start of the baseline phase or during the baseline phase. If only 1 prophylactic medication is used, the dose must be stable within 2 months prior to the start of the baseline phase and throughout the study
- Used a prohibited medication, device, or procedure within 2 months prior to the start of the baseline phase or during the baseline phase.
- Received botulinum toxin
- Anticipated to require any excluded medication, device, or procedure during the study.
- Active chronic pain syndromes (such as fibromyalgia and chronic pelvic pain).
- History of major psychiatric disorder.
- History of seizure disorder or other significant neurological conditions other than migraine.
- Human immunodeficiency virus (HIV) infection by history.
- Myocardial infarction (MI), stroke, transient ischemic attack (TIA), unstable angina, or coronary artery bypass surgery or other revascularization procedure within 12 months prior to screening.
- The subject is at risk of self-harm or harm to others. Previously randomized into an AMG 334 study.
- Unlikely to be able to complete all protocol required study visits or procedures, and/or to comply with all required study procedures.
Data sourced from ClinicalTrials.gov (NCT02483585) 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.