Head-to-head Study of Erenumab Against Topiramate in Patients With Episodic and Chronic Migraine (HER-MES)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03828539 |
Recruitment Status :
Completed
First Posted : February 4, 2019
Last Update Posted : December 8, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Migraine | Biological: Erenumab Drug: Topiramate | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 831 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Masking Description: | Double Blind (Participant and Investigator) |
Primary Purpose: | Prevention |
Official Title: | Head-to-head Study of Erenumab Against topiRamate-a Double-blind, Double Dummy Migraine Study to Assess Tolerability and Efficacy in a patiEnt -Centered Setting |
Actual Study Start Date : | February 22, 2019 |
Actual Primary Completion Date : | July 29, 2020 |
Actual Study Completion Date : | July 29, 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: Erenumab
70 mg and 140 mg Erenumab
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Biological: Erenumab
Pre-filled syringe
Other Name: AMG334 |
Active Comparator: Topiramate
Topiramate in the highest tolerated dose (50 - 100 mg/day)
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Drug: Topiramate
Pill
Other Name: Topamax |
- Number of patients discontinuing treatment due to AE during the double-blind epoch of the study [ Time Frame: 24 weeks ]Tolerability
- Percentage of patients with a 50% response in the reduction of Monthly Migraine Days [ Time Frame: Week 12 - 24 ]Efficacy

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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 naive or not suitable or have failed previous migraine prophylactic treatments
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 BDI
Other protocol-defined inclusion/exclusion criteria may apply.
- Cardiac or hepatic disease

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03828539

Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Responsible Party: | Novartis Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT03828539 |
Other Study ID Numbers: |
CAMG334ADE01 |
First Posted: | February 4, 2019 Key Record Dates |
Last Update Posted: | December 8, 2020 |
Last Verified: | December 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Plan Description: | 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 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | Yes |
migraine erenumab topiramate |
CAMG 334 headache CGRP receptor agonist |
Migraine Disorders Headache Disorders, Primary Headache Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Topiramate Erenumab |
Anticonvulsants Hypoglycemic Agents Physiological Effects of Drugs Calcitonin Gene-Related Peptide Receptor Antagonists Molecular Mechanisms of Pharmacological Action Analgesics Sensory System Agents Peripheral Nervous System Agents |