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

Primary Purpose

Migraine

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Erenumab
Sponsored by
Amgen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Migraine focused on measuring Migraine, Chronic Migraine, Episodic Migraine, Erenumab

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rehabilitation and Neurological Services LLC
  • Elite Clinical Studies LLC
  • Neurology Center of North Orange County
  • The Neurology Group
  • Mountain Neurological Research Center
  • Mindscapes Counseling, LLC
  • Reliable Clinical Research, LLC
  • Homestead Associates In Research Inc
  • The Community Research of South Florida
  • New Age Medical Research Corporation
  • Research Institute of Orlando
  • Pas Research
  • Georgia Institute for Clinical Research, LLC
  • Chicago Headache Center and Research Institute
  • College Park Family Care Center
  • Family HealthCare
  • Neurology Center of New England
  • ActivMed Practices and Research, LLC
  • Memorial Healthcare Foundation
  • SRI International
  • Citizens Memorial Healthcare
  • Psych Care Consultants
  • Clinvest Research LLC
  • Albuquerque Clinical Trials Inc
  • Albany Medical College
  • Dent Neurosciences Research Center
  • Montefiore Medical Center
  • Northwell Health Physician Partners Neuroscience Institute at Great Neck
  • Island Neurological Associates
  • Nuvance Health Medical Practice Primary Care Division of Neurology
  • Asheville Neurology Specialists PA
  • Onsite Clinical Solutions LLC
  • Lynn Health Science Institute
  • Saint Lukes Neurology Associates
  • Clinical Trials of South Carolina
  • Premier Neurology
  • Tri-State Mountain Neurology Associates
  • Pearland Neurology Services PLLC
  • Protenium Clinical Research
  • Houston Neurology Associates
  • Sugar Lakes Family Practice
  • Vaught Neurological Services

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Erenumab

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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).
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.
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.
Mean Change from Baseline in Physical Function Domain Score as Measured by the Migraine Functional Impact Questionnaire (MFIQ) at Week 24
Mean Change from Baseline in Usual Activities Domain Score as Measured by the MFIQ at Week 24
Mean Change from Baseline in Emotional Function Domain Score as Measured by the MFIQ at Week 24
Mean Change from Baseline in Social Function Domain Score as Measured by the MFIQ at Week 24

Full Information

First Posted
March 29, 2021
Last Updated
October 5, 2023
Sponsor
Amgen
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1. Study Identification

Unique Protocol Identification Number
NCT04825678
Brief Title
A Study to Evaluate Treatment Satisfaction With Erenumab in Participants With Migraine
Official Title
Phase 4, Open-label Study to Evaluate Treatment Satisfaction With Erenumab in Patients With Migraine
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
June 11, 2021 (Actual)
Primary Completion Date
September 28, 2023 (Actual)
Study Completion Date
September 28, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
Keywords
Migraine, Chronic Migraine, Episodic Migraine, Erenumab

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Erenumab
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Erenumab
Other Intervention Name(s)
AMG 334
Intervention Description
Administered as a subcutaneous injection via the SureClick® Autoinjector Pen (AI/Pen).
Primary Outcome Measure Information:
Title
Mean Change from Baseline in the Treatment Satisfaction Questionnaire for Medication (TSQM) Overall Satisfaction Scale Score at Week 24
Description
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.
Time Frame
Baseline and Week 24
Secondary Outcome Measure Information:
Title
Number of Participants Achieving Overall Satisfaction at Week 24
Description
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.
Time Frame
Week 24
Title
Number of Participants Reporting Improvement in Participant Global Impression at Week 24
Description
Improvement is defined by participant reporting of much improved or a little improved on the migraine Global Impression Item (mGI-I).
Time Frame
Week 24
Title
Number of Clinician's Reporting Improvement in Treating Clinician's Global Impression at Week 24
Description
Improvement is defined by treating clinician's reporting of much improved or a little improved on the mGI-I for each individual participant.
Time Frame
Week 24
Title
Number of Key Family Member's Reporting Improvement in Key Family Member's Impression at Week 24
Description
Improvement is defined by key family member's reporting of much improved or a little improved on the mGI-I for each individual participant.
Time Frame
Week 24
Title
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
Title
Mean Change from Baseline in Usual Activities Domain Score as Measured by the MFIQ at Week 24
Time Frame
Baseline and Week 24
Title
Mean Change from Baseline in Emotional Function Domain Score as Measured by the MFIQ at Week 24
Time Frame
Baseline and Week 24
Title
Mean Change from Baseline in Social Function Domain Score as Measured by the MFIQ at Week 24
Time Frame
Baseline and Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
Facility Information:
Facility Name
Rehabilitation and Neurological Services LLC
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35805
Country
United States
Facility Name
Elite Clinical Studies LLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
Neurology Center of North Orange County
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
The Neurology Group
City
Pomona
State/Province
California
ZIP/Postal Code
91767
Country
United States
Facility Name
Mountain Neurological Research Center
City
Basalt
State/Province
Colorado
ZIP/Postal Code
81621
Country
United States
Facility Name
Mindscapes Counseling, LLC
City
Norwich
State/Province
Connecticut
ZIP/Postal Code
06360
Country
United States
Facility Name
Reliable Clinical Research, LLC
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Homestead Associates In Research Inc
City
Homestead
State/Province
Florida
ZIP/Postal Code
33032
Country
United States
Facility Name
The Community Research of South Florida
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
New Age Medical Research Corporation
City
Miami
State/Province
Florida
ZIP/Postal Code
33186
Country
United States
Facility Name
Research Institute of Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Pas Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Georgia Institute for Clinical Research, LLC
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Chicago Headache Center and Research Institute
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States
Facility Name
College Park Family Care Center
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66212
Country
United States
Facility Name
Family HealthCare
City
Germantown
State/Province
Maryland
ZIP/Postal Code
20876
Country
United States
Facility Name
Neurology Center of New England
City
Foxboro
State/Province
Massachusetts
ZIP/Postal Code
02035
Country
United States
Facility Name
ActivMed Practices and Research, LLC
City
Lowell
State/Province
Massachusetts
ZIP/Postal Code
01852
Country
United States
Facility Name
Memorial Healthcare Foundation
City
Owosso
State/Province
Michigan
ZIP/Postal Code
48867
Country
United States
Facility Name
SRI International
City
Plymouth
State/Province
Michigan
ZIP/Postal Code
48170
Country
United States
Facility Name
Citizens Memorial Healthcare
City
Bolivar
State/Province
Missouri
ZIP/Postal Code
65613
Country
United States
Facility Name
Psych Care Consultants
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
Clinvest Research LLC
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
Albuquerque Clinical Trials Inc
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Albany Medical College
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Dent Neurosciences Research Center
City
Amherst
State/Province
New York
ZIP/Postal Code
14226
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Northwell Health Physician Partners Neuroscience Institute at Great Neck
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Island Neurological Associates
City
Plainview
State/Province
New York
ZIP/Postal Code
11803
Country
United States
Facility Name
Nuvance Health Medical Practice Primary Care Division of Neurology
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12601
Country
United States
Facility Name
Asheville Neurology Specialists PA
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28806
Country
United States
Facility Name
Onsite Clinical Solutions LLC
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28277
Country
United States
Facility Name
Lynn Health Science Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Saint Lukes Neurology Associates
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18018
Country
United States
Facility Name
Clinical Trials of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Premier Neurology
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29650
Country
United States
Facility Name
Tri-State Mountain Neurology Associates
City
Johnson City
State/Province
Tennessee
ZIP/Postal Code
37604
Country
United States
Facility Name
Pearland Neurology Services PLLC
City
Houston
State/Province
Texas
ZIP/Postal Code
77089
Country
United States
Facility Name
Protenium Clinical Research
City
Hurst
State/Province
Texas
ZIP/Postal Code
76054
Country
United States
Facility Name
Houston Neurology Associates
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77478
Country
United States
Facility Name
Sugar Lakes Family Practice
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Facility Name
Vaught Neurological Services
City
Crab Orchard
State/Province
West Virginia
ZIP/Postal Code
25827
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
http://www.amgen.com/datasharing
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website

Learn more about this trial

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

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