Phase 4
N=512
Erenumab - Comprehensive Assessment of Efficacy in (High-Frequency) Episodic Migraine
Migraine
Bottom Line
View on ClinicalTrials.gov: NCT04252742 ↗Enrolled (actual)
512
Serious AEs
0.4%
Results posted
Aug 2024
Primary outcome: Primary: Change From Baseline in Mean Monthly Hours of at Least Moderate Headache Pain Intensity Over Months 1, 2, and 3 — -23.38; -31.33 hours/month — p=< 0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Erenumab (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Amgen
- Primary completion
- Oct 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Mean Monthly Hours of at Least Moderate Headache Pain Intensity Over Months 1, 2, and 3 |
-23.38; -31.33 | < 0.001 sig |
| SECONDARY Change From Baseline in Mean Monthly Physical Function Domain Score as Measured by the Migraine Functional Impact Questionnaire (MFIQ) Over Months 1, 2, and 3 |
-22.92; -30.28 | < 0.001 sig |
| SECONDARY Change From Baseline in Mean Monthly Usual Activities Domain Score as Measured by the MFIQ Over Months 1, 2, and 3 |
-23.98; -31.08 | < 0.001 sig |
| SECONDARY Change From Baseline in Mean Monthly Emotional Functioning Domain Score as Measured by the MFIQ Over Months 1, 2, and 3 |
-22.77; -29.83 | < 0.001 sig |
| SECONDARY Change From Baseline in Mean Monthly Social Functioning Domain Score as Measured by the MFIQ Over Months 1, 2, and 3 |
-25.05; -31.87 | < 0.001 sig |
| SECONDARY Change From Baseline in Mean Monthly Average Duration of at Least Moderate Headache Pain Intensity in Migraine Attacks Occurring Over Months 1, 2, and 3 |
-2.78; -3.86 | 0.013 sig |
| SECONDARY Change From Baseline in Mean Monthly Average Peak Migraine Pain Intensity as Assessed by the 11-point Numeric Rating Scale (NRS) Over Months 1, 2, and 3 |
-1.48; -1.96 | 0.011 sig |
Summary
The primary objective of this study is to evaluate the treatment benefit of erenumab on headache duration of at least moderate pain intensity.
Eligibility Criteria
Key inclusion criteria include:
- Age greater than or equal to 18 years upon entry into initial screening.
- Documented history of migraine with or without aura according to the International Headache Society (IHS) International Classification of Headache Disorders, Third Edition (ICHD-III) for greater than or equal to 12 months.
- Have high-frequency episodic migraine (HFEM): Defined as history of ≥ 7 to 50% of attacks of at least moderate pain intensity. Regular use is defined as ≥ 4 days of oral triptan use per month during the 3 months prior to screening.
Key exclusion criteria include:
- History of hemiplegic migraine, cluster headache, or other trigeminal autonomic cephalalgia.
- Has any medical contraindication to the use of an oral triptan.
- Previously treated with erenumab.
- Previously treated with a gepant (small molecule calcitonin gene related peptide receptor [CGRP-R] antagonist) in a preventive fashion in a manner consistent with migraine prevention that either:
- In the opinion of the investigator, did not offer any evidence of a therapeutic response or
- Was discontinued for less than 12 weeks from the date of initial screening or
- Was previously discontinued due to a known adverse drug reaction
- Currently being treated with lasmiditan and/or a gepant in the acute setting.
- No therapeutic response with greater than 4 of the defined medication categories after an adequate therapeutic trial.
- Currently has a history of consistent excellent response to oral triptans, defined as achievement of pain-freedom in ≤ 1 hour for ≥ 50% of treated attacks of at least moderate pain intensity during the 3 months prior to screening.
- Use of triptans administered via a non-oral (e.g. subcutaneous [SC] or intranasal delivery systems) or sublingual route at the time of screening, during the run-in and baseline periods, and throughout the study duration.
Data sourced from ClinicalTrials.gov (NCT04252742). 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.