A Study to Evaluate Treatment Satisfaction With Erenumab in Participants With Migraine

Phase 4, Open-label Study to Evaluate Treatment Satisfaction With Erenumab in Patients With Migraine

The main purpose of this study is to evaluate the effect of erenumab on medication-specific treatment satisfaction.

Study Overview

• Status: Completed
• Conditions: Migraine
• Intervention / Treatment: Drug: Erenumab

• Study Type: Interventional
• Enrollment (Actual): 240
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Huntsville, Alabama, United States, 35805
      • Rehabilitation and Neurological Services LLC
  • Arizona
    • Phoenix, Arizona, United States, 85018
      • Elite Clinical Studies LLC
  • California
    • Fullerton, California, United States, 92835
      • Neurology Center of North Orange County
    • Pomona, California, United States, 91767
      • The Neurology Group
  • Colorado
    • Basalt, Colorado, United States, 81621
      • Mountain Neurological Research Center
  • Connecticut
    • Norwich, Connecticut, United States, 06360
      • Mindscapes Counseling, LLC
  • Florida
    • Hialeah, Florida, United States, 33012
      • Reliable Clinical Research, LLC
    • Homestead, Florida, United States, 33032
      • Homestead Associates in Research Inc
    • Miami, Florida, United States, 33186
      • New Age Medical Research Corporation
    • Miami Lakes, Florida, United States, 33016
      • The Community Research of South Florida
    • Orlando, Florida, United States, 32806
      • Research Institute of Orlando
    • Tampa, Florida, United States, 33613
      • PAS Research
  • Georgia
    • Marietta, Georgia, United States, 30060
      • Georgia Institute for Clinical Research, LLC
  • Illinois
    • Chicago, Illinois, United States, 60657
      • Chicago Headache Center and Research Institute
  • Kansas
    • Overland Park, Kansas, United States, 66212
      • College Park Family Care Center
  • Maryland
    • Germantown, Maryland, United States, 20876
      • Family HealthCare
  • Massachusetts
    • Foxboro, Massachusetts, United States, 02035
      • Neurology Center of New England
    • Lowell, Massachusetts, United States, 01852
      • ActivMed Practices and Research, LLC
  • Michigan
    • Owosso, Michigan, United States, 48867
      • Memorial Healthcare Foundation
    • Plymouth, Michigan, United States, 48170
      • SRI International
  • Missouri
    • Bolivar, Missouri, United States, 65613
      • Citizens Memorial Healthcare
    • Saint Louis, Missouri, United States, 63128
      • Psych Care Consultants
    • Springfield, Missouri, United States, 65807
      • Clinvest Research LLC
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Albuquerque Clinical Trials Inc
  • New York
    • Albany, New York, United States, 12208
      • Albany Medical College
    • Amherst, New York, United States, 14226
      • Dent Neurosciences Research Center
    • Bronx, New York, United States, 10461
      • Montefiore Medical Center
    • Great Neck, New York, United States, 11021
      • Northwell Health Physician Partners Neuroscience Institute at Great Neck
    • Plainview, New York, United States, 11803
      • Island Neurological Associates
    • Poughkeepsie, New York, United States, 12601
      • Nuvance Health Medical Practice Primary Care Division of Neurology
  • North Carolina
    • Asheville, North Carolina, United States, 28806
      • Asheville Neurology Specialists PA
    • Charlotte, North Carolina, United States, 28277
      • OnSite Clinical Solutions LLC
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Lynn Health Science Institute
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18018
      • Saint Lukes Neurology Associates
  • South Carolina
    • Charleston, South Carolina, United States, 29406
      • Clinical Trials of South Carolina
    • Greer, South Carolina, United States, 29650
      • Premier Neurology
  • Tennessee
    • Johnson City, Tennessee, United States, 37604
      • Tri-State Mountain Neurology Associates
  • Texas
    • Houston, Texas, United States, 77089
      • Pearland Neurology Services PLLC
    • Hurst, Texas, United States, 76054
      • Protenium Clinical Research
    • Sugar Land, Texas, United States, 77479
      • Sugar Lakes Family Practice
    • Sugar Land, Texas, United States, 77478
      • Houston Neurology Associates
  • West Virginia
    • Crab Orchard, West Virginia, United States, 25827
      • Vaught Neurological Services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥ 18 years
• Participant has provided informed consent
• History of migraine (with or without aura) for ≥ 12 months before screening
• ≥ 4 migraine days per month on average across the 3 months prior to screening
• Treatment with 1 oral migraine preventive medication and/or concomitant use of OnabotulinumtoxinA injections for migraine prevention.
• Participant reports to their provider intolerance or insufficient response with their current preventative treatment

Exclusion Criteria:

• History of cluster headache or hemiplegic migraine headache
• Unable to differentiate migraine from other headaches
• Evidence of substance-related disorders
• Active chronic pain syndromes (eg, fibromyalgia and chronic pelvic pain)
• No therapeutic response with > 3 migraine preventive medication categories
• Used a prohibited medication, device, or procedure
• Other clinically significant disorder, condition, or disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Erenumab	Drug: Erenumab; Administered as a subcutaneous injection via the SureClick® Autoinjector Pen (AI/Pen).; Other Names: AMG 334

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change from Baseline in the Treatment Satisfaction Questionnaire for Medication (TSQM) Overall Satisfaction Scale Score at Week 24	As measured by items 12 to 14 of the TSQM version 1.4. Items 12 and 13 measure confidence in benefits and balance between good and bad things on a 5 point rating scale where 1 indicates least satisfaction and 5 indicates most satisfaction. Item 14 measures global satisfaction on a 7 point rating scale where 1 indicates least satisfaction and 7 indicates most satisfaction.	Baseline and Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Achieving Overall Satisfaction at Week 24	Overall satisfaction is defined by participant reporting of satisfied, very satisfied, or extremely satisfied on item 14 of the TSQM version 1.4. Item 14 of the TSQM measures global satisfaction on a 7 point rating scale where 1 indicates least satisfaction and 7 indicates most satisfaction.	Week 24
Number of Participants Reporting Improvement in Participant Global Impression at Week 24	Improvement is defined by participant reporting of much improved or a little improved on the migraine Global Impression Item (mGI-I).	Week 24
Number of Clinician's Reporting Improvement in Treating Clinician's Global Impression at Week 24	Improvement is defined by treating clinician's reporting of much improved or a little improved on the mGI-I for each individual participant.	Week 24
Number of Key Family Member's Reporting Improvement in Key Family Member's Impression at Week 24	Improvement is defined by key family member's reporting of much improved or a little improved on the mGI-I for each individual participant.	Week 24
Mean Change from Baseline in Physical Function Domain Score as Measured by the Migraine Functional Impact Questionnaire (MFIQ) at Week 24		Baseline and Week 24
Mean Change from Baseline in Usual Activities Domain Score as Measured by the MFIQ at Week 24		Baseline and Week 24
Mean Change from Baseline in Emotional Function Domain Score as Measured by the MFIQ at Week 24		Baseline and Week 24
Mean Change from Baseline in Social Function Domain Score as Measured by the MFIQ at Week 24		Baseline and Week 24

Collaborators and Investigators

• Sponsor: Amgen
• Investigators: Study Director: MD, Amgen

Publications and helpful links

Helpful Links

• AmgenTrials clinical trials website

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2021
• Primary Completion (Actual): September 28, 2023
• Study Completion (Actual): September 28, 2023

Study Registration Dates

• First Submitted: March 29, 2021
• First Submitted That Met QC Criteria: March 29, 2021
• First Posted (Actual): April 1, 2021

Study Record Updates

• Last Update Posted (Actual): October 6, 2023
• Last Update Submitted That Met QC Criteria: October 5, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Migraine; Episodic Migraine; Chronic Migraine; Erenumab
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Calcitonin Gene-Related Peptide Receptor Antagonists; Erenumab
• Other Study ID Numbers: 20190389

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
• IPD Sharing Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• IPD Sharing Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No