Phase 2
N=667
A Study to Evaluate the Efficacy and Safety of Erenumab (AMG 334) in Chronic Migraine Prevention
Treatment for Prevention of Chronic Migraine
Bottom Line
View on ClinicalTrials.gov: NCT02066415 ↗Enrolled (actual)
667
Serious AEs
2.3%
Results posted
Jun 2018
Primary outcome: Primary: Change From Baseline in Monthly Migraine Days — -4.18; -6.64; -6.63 migraine days / month — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Erenumab (Biological); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Amgen
- Primary completion
- Feb 2016
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 | — |
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.
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.