Head-to-head Study of Erenumab Against Topiramate in Patients With Episodic and Chronic Migraine
HER-MES
2 other identifiers
interventional
777
1 country
79
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Feb 2019
79 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 1, 2019
CompletedFirst Posted
Study publicly available on registry
February 4, 2019
CompletedStudy Start
First participant enrolled
February 22, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 29, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 29, 2020
CompletedResults Posted
Study results publicly available
August 9, 2021
CompletedOctober 11, 2021
October 1, 2021
1.4 years
February 1, 2019
July 16, 2021
October 7, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of Patients With Treatment Discontinuation Due to an Adverse Event (AE) During the Double-blind Treatment Epoch/Period (DBTE)
The primary objective was to demonstrate the tolerability of 70 mg and 140 mg erenumab compared to topiramate in the highest tolerated dose assessed by the rate of patients discontinuing treatment due to AE during the double-blind epoch of the study.
24 Weeks
Secondary Outcomes (1)
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)
Baseline, Last three months (month 4, 5, and 6)
Other Outcomes (2)
EXPLORATORY ENDPOINT: Proportion of Patients Achieving at Least a 5 Points Reduction in the Headache Impact Test (HIT-6) From Baseline to Week 24
Baseline, Week 24
EXPLORATORY ENDPOINT: Proportion of Patients Achieving at Least a 5 Points Increase in the Medical Outcome Short Form Health Survey Version 2 (SF-36) From Baseline to Week 24
Baseline, Week 24
Study Arms (2)
Erenumab
EXPERIMENTAL70 mg and 140 mg Erenumab
Topiramate
ACTIVE COMPARATORTopiramate in the highest tolerated dose (50 - 100 mg/day)
Interventions
70mg/1mL (70 mg) or 2x70mg/1mL (140 mg) in pre-filled syringe, administered every 4 weeks
Film-coated tablet taken orally: 25 mg administered once daily (first week of titration phase). After the first week, titration was done according to the summary of product characteristics (SmPC) in 25 mg increments each week and aimed to reach the recommended daily treatment dose of 100 mg (50/75/100 mg). 50/75/100 mg were administered twice daily during titration phase and maintenance phase.
Erenumab matching placebo pre-filled syringue administered every 4 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (79)
Novartis Investigative Site
Stuttgart, Baden-Wurttemberg, 70178, Germany
Novartis Investigative Site
Marburg Wehrda, Germany, 35041, Germany
Novartis Investigative Site
Hanover, Lower Saxony, 30159, Germany
Novartis Investigative Site
Aachen, North Rhine-Westphalia, 52062, Germany
Novartis Investigative Site
Alzenau in Unterfranken, 63755, Germany
Novartis Investigative Site
Bad Homburg, 61348, Germany
Novartis Investigative Site
Bad Honnef, 53604, Germany
Novartis Investigative Site
Bad Saarow, 15526, Germany
Novartis Investigative Site
Bayreuth, 95445, Germany
Novartis Investigative Site
Bergen, 18528, Germany
Novartis Investigative Site
Berlin, 10713, Germany
Novartis Investigative Site
Berlin, 120999, Germany
Novartis Investigative Site
Berlin, 12101, Germany
Novartis Investigative Site
Berlin, 12163, Germany
Novartis Investigative Site
Berlin, 12627, Germany
Novartis Investigative Site
Berlin, 13156, Germany
Novartis Investigative Site
Berlin, 13353, Germany
Novartis Investigative Site
Berlin, 14169, Germany
Novartis Investigative Site
Bielefeld, D 33647, Germany
Novartis Investigative Site
Bochum, 44791, Germany
Novartis Investigative Site
Bonn, 53111, Germany
Novartis Investigative Site
Bonn, 53177, Germany
Novartis Investigative Site
Böblingen, 71032, Germany
Novartis Investigative Site
Celle, 29223, Germany
Novartis Investigative Site
Chemnitz, 09117, Germany
Novartis Investigative Site
Cologne, 50935, Germany
Novartis Investigative Site
Dillingen, 66763, Germany
Novartis Investigative Site
Erbach im Odenwald, 64711, Germany
Novartis Investigative Site
Essen, 45133, Germany
Novartis Investigative Site
Essen, 45147, Germany
Novartis Investigative Site
Frankfurt, 60313, Germany
Novartis Investigative Site
Freiburg im Breisgau, 79098, Germany
Novartis Investigative Site
Gelsenkirchen, 45879, Germany
Novartis Investigative Site
Greifswald, 17475, Germany
Novartis Investigative Site
Haar, 85540, Germany
Novartis Investigative Site
Halle, 06120, Germany
Novartis Investigative Site
Hamburg, 20253, Germany
Novartis Investigative Site
Heidelberg, 69120, Germany
Novartis Investigative Site
Heidenheim, 89518, Germany
Novartis Investigative Site
Hoppegarten, 15366, Germany
Novartis Investigative Site
Ibbenbueren, 49477, Germany
Novartis Investigative Site
Jena, 07740, Germany
Novartis Investigative Site
Jülich, 52428, Germany
Novartis Investigative Site
Kassel, 34121, Germany
Novartis Investigative Site
Kassel, Germany
Novartis Investigative Site
Kiel, 24149, Germany
Novartis Investigative Site
Königstein im Taunus, 61462, Germany
Novartis Investigative Site
Leipzig, 04103, Germany
Novartis Investigative Site
Leipzig, 04107, Germany
Novartis Investigative Site
Lünen, 44534, Germany
Novartis Investigative Site
Mannheim, 66163, Germany
Novartis Investigative Site
Mittweida, 09648, Germany
Novartis Investigative Site
München, 81377, Germany
Novartis Investigative Site
München, 81675, Germany
Novartis Investigative Site
Münster, 48149, Germany
Novartis Investigative Site
Neu-Ulm, 89231, Germany
Novartis Investigative Site
Neuburg an der Donau, 86633, Germany
Novartis Investigative Site
Osnabrück, 49074, Germany
Novartis Investigative Site
Pforzheim, 75172, Germany
Novartis Investigative Site
Quakenbrück, 49610, Germany
Novartis Investigative Site
Regensburg, 93059, Germany
Novartis Investigative Site
Rostock, 18057, Germany
Novartis Investigative Site
Rülzheim, 76761, Germany
Novartis Investigative Site
Schwerin, 19053, Germany
Novartis Investigative Site
Schwerin, 19055, Germany
Novartis Investigative Site
Seesen, 38723, Germany
Novartis Investigative Site
Siegen, 57076, Germany
Novartis Investigative Site
Sindelfingen, 71065, Germany
Novartis Investigative Site
Stadtroda, 07646, Germany
Novartis Investigative Site
Stuttgart, 70174, Germany
Novartis Investigative Site
Stuttgart, 70178, Germany
Novartis Investigative Site
Stuttgart, 70182, Germany
Novartis Investigative Site
Trier, 54292, Germany
Novartis Investigative Site
Tübingen, 72076, Germany
Novartis Investigative Site
Ulm, 89073, Germany
Novartis Investigative Site
Unterhaching, 82008, Germany
Novartis Investigative Site
Westerstede/Oldenburg, 26655, Germany
Novartis Investigative Site
Wiesbaden, 65191, Germany
Novartis Investigative Site
Würzburg, 97080, Germany
Related Publications (2)
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.
PMID: 36380284DERIVEDReuter 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.
PMID: 34743579DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 1, 2019
First Posted
February 4, 2019
Study Start
February 22, 2019
Primary Completion
July 29, 2020
Study Completion
July 29, 2020
Last Updated
October 11, 2021
Results First Posted
August 9, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will share
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com