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

October 5, 2023 updated by: Amgen

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
240

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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
Time Frame: Baseline and 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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants Achieving Overall Satisfaction at Week 24
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: Baseline and Week 24
Baseline and Week 24
Mean Change from Baseline in Usual Activities Domain Score as Measured by the MFIQ at Week 24
Time Frame: Baseline and Week 24
Baseline and Week 24
Mean Change from Baseline in Emotional Function Domain Score as Measured by the MFIQ at Week 24
Time Frame: Baseline and Week 24
Baseline and Week 24
Mean Change from Baseline in Social Function Domain Score as Measured by the MFIQ at Week 24
Time Frame: Baseline and Week 24
Baseline and Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Amgen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: MD, Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 11, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 28, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 28, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 29, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 29, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 1, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 6, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 5, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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