Phase 3
Completed N=955
Study to Evaluate the Efficacy and Safety of Erenumab (AMG 334) in Migraine Prevention
Source: ClinicalTrials.gov NCT02456740 ↗Enrolled (actual)
955
Serious AEs
2.8%
Results posted
Jul 2018
Primary outcomePrimary: Change From Baseline in Mean Monthly Migraine Days to the Last 3 Months of the Double-blind Treatment Period — -1.83; -3.23; -3.67 migraine days / month — p=< 0.001
◆ Published Evidence
Established
41citations · ~10 / year
Assessment of Erenumab Safety and Efficacy in Patients With Migraine With and Without Aura: A Secondary Analysis of Randomized Clinical Trials.
Summary
The primary objective of the study was to evaluate the effect of erenumab compared to placebo on the change from baseline in monthly migraine days.
Linked Publications (5)
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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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The Spectrum of Response to Erenumab in Patients With Episodic Migraine and Subgroup Analysis of Patients Achieving ≥50%, ≥75%, and 100% Response.
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Reduction in acute migraine-specific and non-specific medication use in patients treated with erenumab: post-hoc analyses of episodic and chronic migraine clinical trials.
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Erenumab prevents the occurrence of migraine attacks and not just migraine days: Post-hoc analyses of a phase III study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Mean Monthly Migraine Days to the Last 3 Months of the Double-blind Treatment Period |
-1.83; -3.23; -3.67 | < 0.001 sig |
| SECONDARY Percentage of Participants With at Least a 50% Reduction From Baseline in Monthly Migraine Days in the Last 3 Months of the Double-blind Treatment Phase |
26.6; 43.3; 50.0 | < 0.001 sig |
| SECONDARY Change From Baseline in Monthly Acute Migraine-specific Medication Treatment Days to the Last 3 Months of the Double-blind Treatment Period |
-0.20; -1.13; -1.61 | < 0.001 sig |
| SECONDARY Change From Baseline in Mean Monthly Average Physical Impairment Domain Score Measured by MPFID in the Last 3 Months of the Double-blind Treatment Phase |
-2.38; -4.24; -4.81 | < 0.001 sig |
| SECONDARY Change From Baseline in Mean Monthly Average Impact on Everyday Activities Score Measured by MPFID in the Last 3 Months of the Double-blind Treatment Phase |
-3.30; -5.52; -5.86 | < 0.001 sig |
Eligibility Criteria
Inclusion Criteria
- History of migraine (with or without aura) for ≥ 12 months prior to screening according to the International Headache Society (IHS) International Classification of Headache Disorders (ICHD-3) classification
- Migraine frequency: ≥ 4 and 2 medication categories for prophylactic treatment of migraine after an adequate therapeutic trial
- Used a prohibited medication, device, or procedure within 2 months prior to the start of the baseline phase or during the baseline phase
- 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
Data sourced from ClinicalTrials.gov (NCT02456740) 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.