A Study to Evaluate Treatment Satisfaction With Erenumab in Participants With Migraine
- Registration Number
- NCT04825678
- Lead Sponsor
- Amgen
- Brief Summary
The main purpose of this study is to evaluate the effect of erenumab on medication-specific treatment satisfaction.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 240
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Erenumab Erenumab -
- Primary Outcome Measures
Name Time Method Mean Change From Baseline in the Treatment Satisfaction Questionnaire for Medication (TSQM) Overall Satisfaction Scale Score at Week 24 by SoC 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 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.
- Secondary Outcome Measures
Name Time Method Observed Data: Percentage of Participants Achieving Overall Satisfaction at Week 24 by SoC Week 24 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.GLIMMIX Model Data: Percentage of Participants Achieving Overall Satisfaction at Week 24 by SoC Baseline up to Week 24 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.Observed Data: Percentage of Participants Achieving Overall Satisfaction at Week 24 by Migraine Type Week 24 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.GLIMMIX Model Data: Percentage of Participants Achieving Overall Satisfaction at Week 24 by Migraine Type Baseline up to Week 24 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.Observed Data: Percentage of Participants Reporting Improvement in the Migraine Global Impression Item (mGI-I) at Week 24 by SoC Baseline and Week 24 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.GLIMMIX Model Data: Percentage of Participants Reporting Improvement in the mGI-I at Week 24 by SoC Baseline up to Week 24 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.Observed Data: Percentage of Participants Reporting Improvement in the mGI-I at Week 24 by Migraine Type Baseline and Week 24 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.GLIMMIX Model Data: Percentage of Participants Reporting Improvement in the mGI-I at Week 24 by Migraine Type Baseline up to Week 24 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.Mean Change From Baseline in Domain Scores as Measured by the Migraine Functional Impact Questionnaire (MFIQ) at Week 24 by SoC Baseline and Week 24 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.Mean Change From Baseline in Domain Scores as Measured by the MFIQ at Week 24 by Migraine Type Baseline and Week 24 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.
Trial Locations
- Locations (42)
Asheville Neurology Specialists PA
🇺🇸Asheville, North Carolina, United States
New Age Medical Research Corporation
🇺🇸Miami, Florida, United States
Mountain Neurological Research Center
🇺🇸Basalt, Colorado, United States
SRI International
🇺🇸Plymouth, Michigan, United States
Nuvance Health Medical Practice Primary Care Division of Neurology
🇺🇸Poughkeepsie, New York, United States
Clinvest Research LLC
🇺🇸Springfield, Missouri, United States
Vaught Neurological Services
🇺🇸Crab Orchard, West Virginia, United States
Dent Neurosciences Research Center
🇺🇸Amherst, New York, United States
Island Neurological Associates
🇺🇸Plainview, New York, United States
Family HealthCare
🇺🇸Germantown, Maryland, United States
Memorial Healthcare Foundation
🇺🇸Owosso, Michigan, United States
Citizens Memorial Healthcare
🇺🇸Bolivar, Missouri, United States
Pearland Neurology Services PLLC
🇺🇸Houston, Texas, United States
Protenium Clinical Research
🇺🇸Hurst, Texas, United States
Northwell Health Physician Partners Neuroscience Institute at Great Neck
🇺🇸Great Neck, New York, United States
Psych Care Consultants
🇺🇸Saint Louis, Missouri, United States
ActivMed Practices and Research, LLC
🇺🇸Lowell, Massachusetts, United States
College Park Family Care Center
🇺🇸Overland Park, Kansas, United States
Albany Medical College
🇺🇸Albany, New York, United States
Sugar Lakes Family Practice
🇺🇸Sugar Land, Texas, United States
Rehabilitation and Neurological Services LLC
🇺🇸Huntsville, Alabama, United States
Neurology Center of North Orange County
🇺🇸Fullerton, California, United States
The Neurology Group
🇺🇸Pomona, California, United States
Mindscapes Counseling, LLC
🇺🇸Norwich, Connecticut, United States
Homestead Associates In Research Inc
🇺🇸Homestead, Florida, United States
The Community Research of South Florida
🇺🇸Miami Lakes, Florida, United States
Georgia Institute for Clinical Research, LLC
🇺🇸Marietta, Georgia, United States
Chicago Headache Center and Research Institute
🇺🇸Chicago, Illinois, United States
Neurology Center of New England
🇺🇸Foxboro, Massachusetts, United States
Onsite Clinical Solutions LLC
🇺🇸Charlotte, North Carolina, United States
Houston Neurology Associates
🇺🇸Sugar Land, Texas, United States
Tri-State Mountain Neurology Associates
🇺🇸Johnson City, Tennessee, United States
Reliable Clinical Research, LLC
🇺🇸Hialeah, Florida, United States
Elite Clinical Studies LLC
🇺🇸Phoenix, Arizona, United States
Research Institute of Orlando
🇺🇸Orlando, Florida, United States
Lynn Health Science Institute
🇺🇸Oklahoma City, Oklahoma, United States
Pas Research
🇺🇸Tampa, Florida, United States
Clinical Trials of South Carolina
🇺🇸Charleston, South Carolina, United States
Albuquerque Clinical Trials Inc
🇺🇸Albuquerque, New Mexico, United States
Premier Neurology
🇺🇸Greer, South Carolina, United States
Saint Lukes Neurology Associates
🇺🇸Bethlehem, Pennsylvania, United States
Montefiore Medical Center
🇺🇸Bronx, New York, United States