Phase 3
N=557
Study of Efficacy and Safety of Erenumab in Adult Chronic Migraine Patients
Migraine
Bottom Line
View on ClinicalTrials.gov: NCT03867201 ↗Enrolled (actual)
557
Serious AEs
5.8%
Results posted
May 2025
Primary outcome: Primary: Change From Baseline in Monthly Migraine Days During the Last 4 Weeks of the 12-week Treatment Period — -8.19; -6.62 days — p=0.015
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Erenumab (Biological); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Aug 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Monthly Migraine Days During the Last 4 Weeks of the 12-week Treatment Period |
-8.19; -6.62 | 0.015 sig |
| SECONDARY Change From Baseline in Migraine-related Disability and Productivity as Measured by the mMIDAS During the Last 4 Weeks of the 12-week Treatment Period |
-14.67; -12.93 | — |
| SECONDARY Number of Participants With at Least 50% Reduction From Baseline in Monthly Migraine Days During the Last 4 Weeks of the 12-week Treatment Period |
131; 102 | — |
| SECONDARY Change From Baseline in Monthly Acute Headache Medication Days During the Last 4 Weeks of the 12-week Treatment Period |
-5.34; -4.66 | — |
| SECONDARY Number of Subjects With Adverse Events as a Measure of Safety |
127; 132; 152; 176 | — |
| SECONDARY Number of Subjects With Anti-AMG 334 Antibodies |
0; 0; 0; 0; 9; 0 | — |
Summary
The purpose of this study was to evaluate the efficacy and safety of erenumab in patients with chronic migraine in Asian population.
Eligibility Criteria
key inclusion Criteria
- History of at least 5 attacks of migraine
- ≥ 15 headache days of which ≥ 8 headache days meet criteria as migraine days during the baseline period
- >=80% diary compliance during the baseline period
Key exclusion Criteria
- Older than 50 years of age at migraine onset
- History of cluster or hemiplegic headache
- Evidence of seizure or major psychiatric disorder
- Cardiac or active hepatic disease
- Pregnant or nursing
Data sourced from ClinicalTrials.gov (NCT03867201). 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.