Phase 2
Completed N=667
A Study to Evaluate the Efficacy and Safety of Erenumab (AMG 334) in Chronic Migraine Prevention
Treatment for Prevention of Chronic Migraine
Source: ClinicalTrials.gov NCT02066415 ↗
Enrolled (actual)
667
Serious AEs
2.3%
Results posted
Jun 2018
Primary outcomePrimary: Change From Baseline in Monthly Migraine Days — -4.18; -6.64; -6.63 migraine days / month — p=<0.001
Summary
To evaluate the effect of erenumab compared to placebo on the change from baseline in the number of monthly migraine days in adults with chronic migraine.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Monthly Migraine Days |
-4.18; -6.64; -6.63 | <0.001 sig |
| SECONDARY Percentage of Participants With at Least a 50% Reduction in Monthly Migraine Days From Baseline |
23.5; 39.9; 41.2 | <0.001 sig |
| SECONDARY Change From Baseline in Monthly Acute Migraine-specific Medication Treatment Days |
-1.58; -3.45; -4.13 | <0.001 sig |
| SECONDARY Change From Baseline in Cumulative Monthly Headache Hours |
-55.22; -64.76; -74.53 | 0.28 |
| SECONDARY Number of Participants With Adverse Events |
110; 83; 88; 65; 45; 42 | — |
| SECONDARY Number of Participants Who Developed Antibodies to Erenumab |
11; 3; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- History of at least 5 attacks of migraine without aura and/or migraine with visual sensory, speech and/or language, retinal or brainstem aura.
- History of ≥ 15 headache days per month of which ≥ 8 headache days were assessed by the subject as migraine day.
- ≥ 4 distinct headache episodes, each lasting ≥ 4 hours OR if shorter, associated with use of a triptan or ergot-derivative on the same calendar day based on the eDiary calculations.
- Demonstrated at least 80% compliance with the eDiary.
Exclusion Criteria
- History of cluster headache or hemiplegic migraine headache
- Unable to differentiate migraine from other headaches
- Failed > 3 medication categories due to lack of efficacy for prophylactic treatment of migraine .
- Received botulinum toxinin head or neck region within 4 months prior to screening.
- Used a prohibited migraine prophylactic medication, device or procedure within 2 months prior to the start of the baseline phase
Data sourced from ClinicalTrials.gov (NCT02066415). 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.