Real World Effectiveness of Eptinezumab in Participants With Migraine

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine how eptinezumab compares to other advanced preventive medications in a real-world community setting in adult participants with episodic migraine (EM) or chronic migraine (CM). These objectives include exploring the comparative effectiveness on patient reported outcomes.

Official Title
-----------------
An Exploratory, Prospective, Randomized, Pragmatic Open Label Cohort Study to Evaluate the Comparative Effectiveness of Eptinezumab in the United States

Conditions
-----------------
Migraine

Intervention / Treatment
-----------------
* Drug: Eptinezumab
* Drug: Erenumab
* Drug: Onabotulinumtoxin-A
* Drug: Fremanezumab
* Drug: Galcanezumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have a diagnosis of migraine per International Headache Society (IHS) International Classification of Headache Disorder (ICHD)-3 guidelines at least 12 months prior to screening. Have a history of ≥ 8 migraine days/month in 2 of the previous 3 months as confirmed by the treating physician through medical records. Be able to understand the clinical description of treatment options and have the capability to participate fully in making their treatment preferences known. Be willing to accept randomization to any of the possible study medications if allocated to that treatment arm. Be willing and capable of completing daily reports and other participant reported outcome measures using a smartphone-based application. Exclusion Criteria: The participant has a history of severe drug allergy or hypersensitivity, or known hypersensitivity or intolerance to either eptinezumab, erenumab, fremanezumab, galcanezumab or their excipients. The participant has previous history of use of any of the study drugs (for example, eptinezumab, Botox, erenumab, fremanezumab or galcanezumab). Note that only previous Botox use for treatment of migraine is exclusionary. Prior use of Botox for cosmetic purposes is allowed. The participant has a diagnosis of CM and has hypersensitivity to botulinum toxin preparation or to any of the components in the formulation. The participant has used opioids or butalbital-containing products greater than 4 days per month in the last month. Other inclusion and exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Eptinezumab<br>Participants will receive eptinezumab via intravenous (IV) infusion on Day 0 and Day 84. | Drug: Eptinezumab<br>* Concentrate for solution for IV infusion<br>* Other names: Vyepti;|
| Experimental: Anti-CGRP injectables<br>Participants are free to select treatment from one of 3 calcitonin gene-related peptide (CGRP) inhibitors: erenumab, fremanezumab, or galcanezumab. CGRP inhibitors will be administered via subcutaneous (SC) injection on Day 0 and then, per product label. | Drug: Erenumab<br>* Solution for SC Injection<br>* Other names: Aimovig®;Drug: Fremanezumab<br>* Solution for SC Injection<br>* Other names: Ajovy®;Drug: Galcanezumab<br>* Solution for SC Injection<br>* Other names: Emgality®;|
| Experimental: Onabotulinumtoxin-A<br>Onabotulinumtoxin-A will be administered via intramuscular (IM) injection on Day 0 and Day 84. | Drug: Onabotulinumtoxin-A<br>* Solution for IM Injection<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Patient-informed Most Bothersome Symptom (PI-MBS) Score |  | Baseline, Week 24 | 
| Number of Good days From Baseline |  | Up to Week 24 | 
| Change From Baseline in Quality of Life (QOL) as Measured by the 5 Level Euro Quality of Life 5 Dimensional Questionnaire (EQ-5D-5L) |  | Baseline, Week 24 | 
| Health Care Resources Utilization (HCRU) |  | Up to Week 24 | 
| QOL as Measured by the 6 Item Headache Impact Test (HIT-6) Score |  | Up to Week 24 | 
| QOL as Measured by the Migraine Disability Assessment (MIDAS) Total Score |  | Up to Week 24 | 
| Participant Satisfaction Score as Measured by the Treatment Satisfaction Questionnaire for Medication (TSQM) |  | Week 24 | 
| Percentage of Participants that Switch From the Preventive Medication they are Randomized to at Baseline to Another Preventive Medication |  | Week 24 |