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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 )

Tracking Information
First Submitted Date  ICMJE February 1, 2019
First Posted Date  ICMJE February 4, 2019
Last Update Posted Date February 17, 2020
Actual Study Start Date  ICMJE December 19, 2018
Estimated Primary Completion Date June 17, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 1, 2019)
Number of patients discontinuing treatment due to AE during the double-blind epoch of the study [ Time Frame: 24 weeks ]
Tolerability
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 1, 2019)
Percentage of patients with a 50% response in the reduction of Monthly Migraine Days [ Time Frame: Week 12 - 24 ]
Efficacy
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Head-to-head Study of Erenumab Against Topiramate in Patients With Episodic Migraine
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description:
Double Blind (Participant and Investigator)
Primary Purpose: Prevention
Condition  ICMJE Episodic Migraine
Intervention  ICMJE
  • Biological: Erenumab
    Pre-filled syringe
    Other Name: AMG334
  • Drug: Topiramate
    Pill
    Other Name: Topamax
Study Arms  ICMJE
  • Experimental: Erenumab
    70 mg and 140 mg Erenumab
    Intervention: Biological: Erenumab
  • Active Comparator: Topiramate
    Topiramate in the highest tolerated dose (50 - 100 mg/day)
    Intervention: Drug: Topiramate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 14, 2020)
770
Original Estimated Enrollment  ICMJE
 (submitted: February 1, 2019)
700
Estimated Study Completion Date  ICMJE June 17, 2020
Estimated Primary Completion Date June 17, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Novartis Pharmaceuticals +41613241111 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03828539
Other Study ID Numbers  ICMJE CAMG334ADE01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
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

Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP