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

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

Official Title
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Phase 4, Open-label Study to Evaluate Treatment Satisfaction With Erenumab in Patients With Migraine

Conditions
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Migraine

Intervention / Treatment
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* Drug: Erenumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Erenumab<br> | Drug: Erenumab<br>* Administered as a subcutaneous injection via the SureClick® Autoinjector Pen (AI/Pen).<br>* Other names: AMG 334;|

What is the study measuring?
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Primary Outcome Measures

| 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 | 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Week 24 | 
| 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). | Week 24 | 
| 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. | Week 24 | 
| 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. | Week 24 | 
| Mean Change from Baseline in Physical Function Domain Score as Measured by the Migraine Functional Impact Questionnaire (MFIQ) at Week 24 |  | Baseline and Week 24 | 
| Mean Change from Baseline in Usual Activities Domain Score as Measured by the MFIQ at Week 24 |  | Baseline and Week 24 | 
| Mean Change from Baseline in Emotional Function Domain Score as Measured by the MFIQ at Week 24 |  | Baseline and Week 24 | 
| Mean Change from Baseline in Social Function Domain Score as Measured by the MFIQ at Week 24 |  | Baseline and Week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Migraine, Chronic Migraine, Episodic Migraine, Erenumab