The main purpose of this study is to evaluate the effect of erenumab on medication-specific treatment satisfaction.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
240
Administered as a subcutaneous injection via the SureClick® Autoinjector Pen (AI/Pen).
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.
Time frame: 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.
Time frame: Baseline and Week 24
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.
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Rehabilitation and Neurological Services LLC
Huntsville, Alabama, United States
Elite Clinical Studies LLC
Phoenix, Arizona, United States
Neurology Center of North Orange County
Fullerton, California, United States
The Neurology Group
Pomona, California, United States
Mountain Neurological Research Center
Basalt, Colorado, United States
Mindscapes Counseling, LLC
Norwich, Connecticut, United States
Reliable Clinical Research, LLC
Hialeah, Florida, United States
Homestead Associates In Research Inc
Homestead, Florida, United States
New Age Medical Research Corporation
Miami, Florida, United States
The Community Research of South Florida
Miami Lakes, Florida, United States
...and 32 more locations
Time frame: 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.
Time frame: 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.
Time frame: 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.
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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
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.
Time frame: 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.
Time frame: Baseline and Week 24