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Head-to-head Study of Erenumab Against Topiramate in Patients With Episodic 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03828539
Recruitment Status : Recruiting
First Posted : February 4, 2019
Last Update Posted : February 17, 2020
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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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 4 - 14 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
Episodic Migraine Biological: Erenumab Drug: Topiramate Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 770 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 : December 19, 2018
Estimated Primary Completion Date : June 17, 2020
Estimated Study Completion Date : June 17, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine
Drug Information available for: Topiramate

Arms and Interventions
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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
Pill
Other Name: Topamax


Outcome Measures
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Primary Outcome Measures :
  1. Number of patients discontinuing treatment due to AE during the double-blind epoch of the study [ Time Frame: 24 weeks ]
    Tolerability


Secondary Outcome Measures :
  1. Percentage of patients with a 50% response in the reduction of Monthly Migraine Days [ Time Frame: Week 12 - 24 ]
    Efficacy


Eligibility Criteria
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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
Criteria

Inclusion Criteria:

  • Documented history of migraine in the 12 months prior to screen
  • 4-14 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
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT03828539


Contacts
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Contact: Novartis Pharmaceuticals +41613241111 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals

Locations
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Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03828539    
Other Study ID Numbers: CAMG334ADE01
First Posted: February 4, 2019    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: February 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

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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 ):
migraine
erenumab
topiramate
 CAMG 334
headache
CGRP receptor agonist
Additional relevant MeSH terms:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Topiramate
Erenumab
Antibodies, Monoclonal
 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
Immunologic Factors