Phase 4
Completed N=777
Head-to-head Study of Erenumab Against Topiramate in Patients With Episodic and Chronic Migraine
Source: ClinicalTrials.gov NCT03828539 ↗Enrolled (actual)
777
Serious AEs
3.7%
Results posted
Aug 2021
Primary outcomePrimary: Proportion of Patients With Treatment Discontinuation Due to an Adverse Event (AE) During the Double-blind Treatment Epoch/Period (DBTE) — 41; 151 Participants — p=<.001
◆ Published Evidence
Highly cited
179citations · ~45 / year
Erenumab versus topiramate for the prevention of migraine - a randomised, double-blind, active-controlled phase 4 trial.
Summary
This study used a single-cohort, 2-treatment arm, parallel-group randomized, double-blind, double-dummy design in adult patients with episodic migraine and chronic migraine, who had to be either naïve or not suitable for or could have failed up to three prophylactic treatments out of: propranolol/metoprolol, amitriptyline, flunarizine. Patients were stratified into groups according to their number of migraine days during the baseline period.
Linked Publications (2)
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Erenumab versus topiramate for the prevention of migraine - a randomised, double-blind, active-controlled phase 4 trial.
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Erenumab versus topiramate: post hoc efficacy analysis from the HER-MES study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Patients With Treatment Discontinuation Due to an Adverse Event (AE) During the Double-blind Treatment Epoch/Period (DBTE) |
41; 151 | <.001 sig |
| SECONDARY Number of Patients With at Least 50% Reduction From Baseline in Monthly Migraine Days (MMD) Over the Last Three Months (Month 4, 5, and 6) |
215; 121 | <.001 sig |
Eligibility Criteria
Key Inclusion Criteria
- Documented history of migraine in the 12 months prior to screen
- at least 4 days per month of migraine symptoms
- >=80% diary compliance during the Baseline period
- Patients must be either naïve or not suitable or have failed previous migraine prophylactic treatments
Key Exclusion Criteria
- Older than 50 years of age at migraine onset
- Pregnant or nursing
- History of cluster or hemiplegic headache
- History or evidence of major psychiatric disorder
- Score of 19 or higher on Beck Depression Inventory (BDI)
Data sourced from ClinicalTrials.gov (NCT03828539) 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.