Head-to-head Study of Erenumab Against Topiramate in Patients With Episodic and Chronic Migraine
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.
Timeline
- Start
- 2019-02-22
- Primary completion
- 2020-07-29
- Completion
- 2020-07-29
Outcome
Met primary endpoint
registry analysis (other test); Erenumab vs Topiramate; p <.001; Odds Ratio (OR) 0.19 (95% CI 0.13 to 0.27); Regression, Logistic reads as unknown NCT03828539 ↗
paper In the erenumab group, 10.6% discontinued medication due to adverse events compared to 38.9% in the topiramate group reads as unknown PMID 34743579 ↗
release “(HER-MES) achieved superiority in its primary and secondary endpoints” reads as met primary endpoint novartis.com ↗
release “Phase IV study, patients in the Aimovig arm demonstrated a significantly lower discontinuation rate due to adverse events versus patients in the topiramate arm” reads as met primary endpoint amgen.com ↗
Publications
- Ehrlich M, Hentschke C, Sieder C, Maier-Peuschel M, Reuter U. Erenumab versus topiramate: post hoc efficacy analysis from the HER-MES study. J Headache Pain. 2022 Nov 15;23(1):141. doi: 10.1186/s10194-022-01511-y.
- Reuter U, Ehrlich M, Gendolla A, Heinze A, Klatt J, Wen S, Hours-Zesiger P, Nickisch J, Sieder C, Hentschke C, Maier-Peuschel M. Erenumab versus topiramate for the prevention of migraine - a randomised, double-blind, active-controlled phase 4 trial. Cephalalgia. 2022 Feb;42(2):108-118. doi: 10.1177/03331024211053571. Epub 2021 Nov 7.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Erenumab | Monoclonal antibody | 70 mg | Subcutaneous |
| Subject | Erenumab | Monoclonal antibody | 140 mg | Subcutaneous |
| Comparator | Topiramate | Small molecule | 50 mg | Oral |
| Comparator | Topiramate | Small molecule | 75 mg | Oral |
| Comparator | Topiramate | Small molecule | 100 mg | Oral |