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Head-to-head Study of Erenumab Against Topiramate in Patients With Episodic and Chronic Migraine (HER-MES)

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. Identifier: NCT03828539
Recruitment Status : Completed
First Posted : February 4, 2019
Last Update Posted : April 23, 2021
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
The purpose of this study is to determine the safety and efficacy of 70 mg and 140 mg AMG 334 compared to topiramate in the highest tolerated dose in patients suffering from at least 4 migraine days/months, who are naïve or not suitable for or have previously failed up to three prophylactic migraine treatments.

Condition or disease Intervention/treatment Phase
Migraine Biological: Erenumab Drug: Topiramate Phase 4

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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

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Migraine
MedlinePlus related topics: Migraine
Drug Information available for: Topiramate

Arm Intervention/treatment
Experimental: Erenumab
70 mg and 140 mg Erenumab
Biological: Erenumab
Pre-filled syringe
Other Name: AMG334

Active Comparator: Topiramate
Topiramate in the highest tolerated dose (50 - 100 mg/day)
Drug: Topiramate
Other Name: Topamax

Primary Outcome Measures :
  1. Rate of patients discontinuing treatment due to Adverse Events (AE) double-blind treatment period [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Number of patients with at least 50% reduction from baseline in monthly migraine days (MMD) [ Time Frame: Week 12 - 24 ]

Information from the National Library of Medicine

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.

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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

Information from the National Library of Medicine

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 identifier (NCT number): NCT03828539

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Sponsors and Collaborators
Novartis Pharmaceuticals
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
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Responsible Party: Novartis Pharmaceuticals Identifier: NCT03828539    
Other Study ID Numbers: CAMG334ADE01
2018-000943-15 ( EudraCT Number )
First Posted: February 4, 2019    Key Record Dates
Last Update Posted: April 23, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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

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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
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Episodic migraine
Chronic migraine
CAMG 334
Calcitonin Gene-related Peptide
CGRP receptor agonist
monoclonal antibody
treatment failure
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Calcitonin Gene-Related Peptide Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Sensory System Agents
Peripheral Nervous System Agents