MigrainePhase 4NCT04825678
A Study to Evaluate Treatment Satisfaction With Erenumab in Participants With Migraine
A Phase 4 study testing Erenumab in people with Migraine, run by Amgen at 42 sites in United States.
Trial summary
The main purpose of this study is to evaluate the effect of erenumab on medication-specific treatment satisfaction. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Migraine
- What is being tested?
- Erenumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 42 sitesUnited States
- Study dates
- 11 Jun 2021to 28 Sep 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
42 sites in 1 country.
42 sites in 1 country
United States42 sites
Albany Medical College
Albany, New York, 12208
Albuquerque Clinical Trials Inc
Albuquerque, New Mexico, 87102
Dent Neurosciences Research Center
Amherst, New York, 14226
Asheville Neurology Specialists PA
Asheville, North Carolina, 28806
Mountain Neurological Research Center
Basalt, Colorado, 81621
Saint Lukes Neurology Associates
Bethlehem, Pennsylvania, 18018
Citizens Memorial Healthcare
Bolivar, Missouri, 65613
Clinical Trials of South Carolina
Charleston, South Carolina, 29406
Onsite Clinical Solutions LLC
Charlotte, North Carolina, 28277
Chicago Headache Center and Research Institute
Chicago, Illinois, 60657
Vaught Neurological Services
Crab Orchard, West Virginia, 25827
Neurology Center of New England
Foxborough, Massachusetts, 02035
Neurology Center of North Orange County
Fullerton, California, 92835
Family HealthCare
Germantown, Maryland, 20876
Northwell Health Physician Partners Neuroscience Institute at Great Neck
Great Neck, New York, 11021
Premier Neurology
Greer, South Carolina, 29650
Reliable Clinical Research, LLC
Hialeah, Florida, 33012
Homestead Associates In Research Inc
Homestead, Florida, 33032
Pearland Neurology Services PLLC
Houston, Texas, 77089
Rehabilitation and Neurological Services LLC
Huntsville, Alabama, 35805
Protenium Clinical Research
Hurst, Texas, 76054
Tri-State Mountain Neurology Associates
Johnson City, Tennessee, 37604
ActivMed Practices and Research, LLC
Lowell, Massachusetts, 01852
Georgia Institute for Clinical Research, LLC
Marietta, Georgia, 30060
New Age Medical Research Corporation
Miami, Florida, 33186
The Community Research of South Florida
Miami Lakes, Florida, 33016
Mindscapes Counseling, LLC
Norwich, Connecticut, 06360
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112
Research Institute of Orlando
Orlando, Florida, 32806
College Park Family Care Center
Overland Park, Kansas, 66212
Memorial Healthcare Foundation
Owosso, Michigan, 48867
Elite Clinical Studies LLC
Phoenix, Arizona, 85018
Island Neurological Associates
Plainview, New York, 11803
SRI International
Plymouth, Michigan, 48170
The Neurology Group
Pomona, California, 91767
Nuvance Health Medical Practice Primary Care Division of Neurology
Poughkeepsie, New York, 12601
Clinvest Research LLC
Springfield, Missouri, 65807
Psych Care Consultants
St Louis, Missouri, 63128
Houston Neurology Associates
Sugar Land, Texas, 77478
Sugar Lakes Family Practice
Sugar Land, Texas, 77479
Pas Research
Tampa, Florida, 33613
Montefiore Medical Center
The Bronx, New York, 10461
About this study
Official title: 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.
- Conditions
- Migraine
- Being tested
- Erenumab
- Keywords
- Migraine, Chronic Migraine, Episodic Migraine, Erenumab
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErenumabDrug
Also called AMG 334
Administered as a subcutaneous injection via the SureClick® Autoinjector Pen (AI/Pen).
| Study group | Role | What they receive |
|---|---|---|
| Erenumab | Experimental | Not described Receives: Drug: Erenumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline in the Treatment Satisfaction Questionnaire for Medication (TSQM) Overall Satisfaction Scale Score at Week 24 by SoC
The TSQM version 1.4 is a 14-item instrument designed to measure important dimensions of participants' experiences with their medication. It has 4 domains: effectiveness, side effects, convenience, and overall satisfaction. Overall satisfaction scores could range from 0 to 100, with higher scores indicating greater satisfaction. A positive change from Baseline represents an increase in overall medication satisfaction.
Worst postbaseline value observed up to erenumab discontinuation was used for participants who discontinued erenumab due to lack of efficacy or adverse event; missing value used for participants who discontinued erenumab due to other reasons.
Measured: Baseline and Week 24
Mean Change From Baseline in the Treatment Satisfaction Questionnaire for Medication (TSQM) Overall Satisfaction Scale Score at Week 24 by Migraine Type
The TSQM version 1.4 is a 14-item instrument designed to measure important dimensions of participants' experiences with their medication. It has 4 domains: effectiveness, side effects, convenience, and overall satisfaction. Overall satisfaction scores could range from 0 to 100, with higher scores indicating greater satisfaction. A positive change from Baseline represents an increase in overall medication satisfaction.
Worst postbaseline value observed up to erenumab discontinuation was used for participants who discontinued erenumab due to lack of efficacy or adverse event; missing value used for participants who discontinued erenumab due to other reasons.
Measured: Baseline and Week 24
Secondary outcomes (10)
Observed Data: Percentage of Participants Achieving Overall Satisfaction at Week 24 by SoC
Overall satisfaction is defined as the percentage of participants 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.
Summary statistics using observed data (after intercurrent event handling) presented. The 95% confidence interval (CI) is for the percentage of responders and was calculated using the Clopper-Pearson method.
Measured: Week 24
GLIMMIX Model Data: Percentage of Participants Achieving Overall Satisfaction at Week 24 by SoC
Overall satisfaction is defined as the percentage of participants 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.
The estimated percentage and CI presented were obtained from a generalized linear mixed model with a logit link which includes Baseline achievement of overall satisfaction, visit, observed Baseline MMD, and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure. The model includes data from all visits during treatment period. The 95% CI is for the percentage of responders and was calculated using the Clopper-Pearson method.
Measured: Baseline up to Week 24
Observed Data: Percentage of Participants Achieving Overall Satisfaction at Week 24 by Migraine Type
Overall satisfaction is defined as the percentage of participants 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.
Summary statistics using observed data (after intercurrent event handling) presented. The 95% CI is for the percentage of responders and was calculated using the Clopper-Pearson method.
Measured: Week 24
GLIMMIX Model Data: Percentage of Participants Achieving Overall Satisfaction at Week 24 by Migraine Type
Overall satisfaction is defined as the percentage of participants 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.
The estimated percentage and CI presented were obtained from a generalized linear mixed model with a logit link which includes Baseline achievement of overall satisfaction, visit, observed Baseline MMD, and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure. The model includes data from all visits during treatment period. The 95% CI is for the percentage of responders and was calculated using the Clopper-Pearson method.
Measured: Baseline up to Week 24
Observed Data: Percentage of Participants Reporting Improvement in the Migraine Global Impression Item (mGI-I) at Week 24 by SoC
Improvement is defined as the percentage of participants reporting of much improved or a little improved on the mGI-I. The mGI-I is a single item instrument designed to measure improvement/worsening in migraine. The 3 versions of the instrument include the perspective of study participants, treating clinicians, and key family members measured on the following scale: much improved; a little improved; no change; a little worse; or much worse. The recall period is the past 7 days.
Summary statistics using observed data (after intercurrent event handling) presented. The 95% CI is for the percentage of responders and was calculated using the Clopper-Pearson method.
Measured: Baseline and Week 24
GLIMMIX Model Data: Percentage of Participants Reporting Improvement in the mGI-I at Week 24 by SoC
Improvement is defined as the percentage of participants reporting of much improved or a little improved on the mGI-I. The mGI-I is a single item instrument designed to measure improvement/worsening in migraine. The 3 versions of the instrument include the perspective of study participants, treating clinicians, and key family members measured on the following scale: much improved; a little improved; no change; a little worse; or much worse. The recall period is the past 7 days.
The estimated percentage and CI presented were obtained from a generalized linear mixed model with a logit link which includes visit, observed Baseline MMD, and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure. The model includes data from all visits during treatment period. The 95% CI is for the percentage of responders and was calculated using the Clopper-Pearson method.
Measured: Baseline up to Week 24
Observed Data: Percentage of Participants Reporting Improvement in the mGI-I at Week 24 by Migraine Type
Improvement is defined as the percentage of participants reporting of much improved or a little improved on the mGI-I. The mGI-I is a single item instrument designed to measure improvement/worsening in migraine. The 3 versions of the instrument include the perspective of study participants, treating clinicians, and key family members measured on the following scale: much improved; a little improved; no change; a little worse; or much worse. The recall period is the past 7 days.
Summary statistics using observed data (after intercurrent event handling) presented. The 95% CI is for the percentage of responders and was calculated using the Clopper-Pearson method.
Measured: Baseline and Week 24
GLIMMIX Model Data: Percentage of Participants Reporting Improvement in the mGI-I at Week 24 by Migraine Type
Improvement is defined as the percentage of participants reporting of much improved or a little improved on the mGI-I. The mGI-I is a single item instrument designed to measure improvement/worsening in migraine. The 3 versions of the instrument include the perspective of study participants, treating clinicians, and key family members measured on the following scale: much improved; a little improved; no change; a little worse; or much worse. The recall period is the past 7 days.
The estimated percentage and CI presented were obtained from a generalized linear mixed model with a logit link which includes visit, observed Baseline MMD, and selected Baseline characteristics as covariates and assumes a first-order auto regression covariance structure. The model includes data from all visits during treatment period. The 95% CI is for the percentage of responders and was calculated using the Clopper-Pearson method.
Measured: Baseline up to Week 24
Mean Change From Baseline in Domain Scores as Measured by the Migraine Functional Impact Questionnaire (MFIQ) at Week 24 by SoC
The MFIQ version 2.0 is a self-administered 26-item instrument measuring the impact of migraine on broader functioning including 4 domains: Impact on Physical Functioning, Impact on Usual Activities, Impact on Social Functioning, and Impact on Emotional Functioning. In addition, there is 1 stand-alone global item assessing the overall impact on usual activities. Participants respond to each item using a 5-point scale assigned scores from 1 to 5, with 5 representing the greatest burden. Each domain score was calculated as the sum of the item responses (i.e., raw score) and rescaled to a 0-100 scale, with higher scores representing greater burden. A negative change from baseline represents a reduction in burden. The recall period is the past 7 days.
Summary statistics using observed data (after intercurrent event handling) presented.
Measured: Baseline and Week 24
Mean Change From Baseline in Domain Scores as Measured by the MFIQ at Week 24 by Migraine Type
The MFIQ version 2.0 is a self-administered 26-item instrument measuring the impact of migraine on broader functioning including 4 domains: Impact on Physical Functioning, Impact on Usual Activities, Impact on Social Functioning, and Impact on Emotional Functioning. In addition, there is 1 stand-alone global item assessing the overall impact on usual activities. Participants respond to each item using a 5-point scale assigned scores from 1 to 5, with 5 representing the greatest burden. Each domain score was calculated as the sum of the item responses (i.e., raw score) and rescaled to a 0-100 scale, with higher scores representing greater burden. A negative change from baseline represents a reduction in burden. The recall period is the past 7 days.
Summary statistics using observed data (after intercurrent event handling) presented.
Measured: Baseline and Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start11 Jun 2021
- Primary completion28 Sep 2023
- Study completion28 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04825678
- Sponsor's protocol ID
- 20190389
- Status last verified
- Sep 2024
- First submitted
- 29 Mar 2021
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4, Open-label Study to Evaluate Treatment Satisfaction With Erenumab in Patients With Migraine
- ClinicalTrials.gov ID
- NCT04825678
- Acronym / sponsor ID
- 20190389
- Conditions
- Migraine
- Keywords
- Migraine, Chronic Migraine, Episodic Migraine, Erenumab
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 11 Jun 2021 (actual)
- Primary completion
- 28 Sep 2023 (actual)
- Study completion
- 28 Sep 2023 (actual)
- First posted
- 1 Apr 2021 (actual)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to evaluate the effect of erenumab on medication-specific treatment satisfaction.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Erenumab | Experimental | Drug: Erenumab |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ErenumabAlso: AMG 334Administered as a subcutaneous injection via the SureClick® Autoinjector Pen (AI/Pen). | Drug | Erenumab |
Primary outcome
Mean Change From Baseline in the Treatment Satisfaction Questionnaire for Medication (TSQM) Overall Satisfaction Scale Score at Week 24 by SoC
Time frame: Baseline and Week 24
The TSQM version 1.4 is a 14-item instrument designed to measure important dimensions of participants' experiences with their medication. It has 4 domains: effectiveness, side effects, convenience, and overall satisfaction. Overall satisfaction scores could range from 0 to 100, with higher scores indicating greater satisfaction. A positive change from Baseline represents an increase in overall medication satisfaction. Worst postbaseline value observed up to erenumab discontinuation was used for participants who discontinued erenumab due to lack of efficacy or adverse event; missing value used for participants who discontinued erenumab due to other reasons.
Mean Change From Baseline in the Treatment Satisfaction Questionnaire for Medication (TSQM) Overall Satisfaction Scale Score at Week 24 by Migraine Type
Time frame: Baseline and Week 24
The TSQM version 1.4 is a 14-item instrument designed to measure important dimensions of participants' experiences with their medication. It has 4 domains: effectiveness, side effects, convenience, and overall satisfaction. Overall satisfaction scores could range from 0 to 100, with higher scores indicating greater satisfaction. A positive change from Baseline represents an increase in overall medication satisfaction. Worst postbaseline value observed up to erenumab discontinuation was used for participants who discontinued erenumab due to lack of efficacy or adverse event; missing value used for participants who discontinued erenumab due to other reasons.
10 secondary outcomes
Observed Data: Percentage of Participants Achieving Overall Satisfaction at Week 24 by SoC
Time frame: Week 24
GLIMMIX Model Data: Percentage of Participants Achieving Overall Satisfaction at Week 24 by SoC
Time frame: Baseline up to Week 24
Observed Data: Percentage of Participants Achieving Overall Satisfaction at Week 24 by Migraine Type
Time frame: Week 24
GLIMMIX Model Data: Percentage of Participants Achieving Overall Satisfaction at Week 24 by Migraine Type
Time frame: Baseline up to Week 24
Observed Data: Percentage of Participants Reporting Improvement in the Migraine Global Impression Item (mGI-I) at Week 24 by SoC
Time frame: Baseline and Week 24
GLIMMIX Model Data: Percentage of Participants Reporting Improvement in the mGI-I at Week 24 by SoC
Time frame: Baseline up to Week 24
Observed Data: Percentage of Participants Reporting Improvement in the mGI-I at Week 24 by Migraine Type
Time frame: Baseline and Week 24
GLIMMIX Model Data: Percentage of Participants Reporting Improvement in the mGI-I at Week 24 by Migraine Type
Time frame: Baseline up to Week 24
Mean Change From Baseline in Domain Scores as Measured by the Migraine Functional Impact Questionnaire (MFIQ) at Week 24 by SoC
Time frame: Baseline and Week 24
Mean Change From Baseline in Domain Scores as Measured by the MFIQ at Week 24 by Migraine Type
Time frame: Baseline and Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
42 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Erenumab in people with Migraine, run by Amgen at 42 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change From Baseline in the Treatment Satisfaction Questionnaire for Medication (TSQM) Overall Satisfaction Scale Score at Week 24 by SoC (time frame: Baseline and Week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.