Phase 3
N=577
Study to Evaluate the Efficacy and Safety of Erenumab (AMG 334) Compared to Placebo in Migraine Prevention
Migraine
Bottom Line
View on ClinicalTrials.gov: NCT02483585 ↗Enrolled (actual)
577
Serious AEs
2.1%
Results posted
Jun 2018
Primary outcome: Primary: Change From Baseline in Monthly Migraine Days at Week 12 — -1.84; -2.88 migraine days / month — p=< 0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Erenumab (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Amgen
- Primary completion
- Jul 2016
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 | — |
Summary
To evaluate the effect of erenumab compared to placebo on the change from baseline in monthly migraine days, in adults with episodic migraine.
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). 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.