Real World Effectiveness of Eptinezumab in Participants With Migraine (EVEC)

Lundbeck

Status and phase: Terminated; Phase 4

Conditions: Migraine

Treatments: Drug: Fremanezumab; Drug: Eptinezumab; Drug: Erenumab; Drug: Onabotulinumtoxin-A; Drug: Galcanezumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT05284019

19766N

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 3 patient groups

Eptinezumab

Experimental group

Description:

Participants will receive eptinezumab via intravenous (IV) infusion on Day 0 and Day 84.

Treatment:

Drug: Eptinezumab

Anti-CGRP injectables

Experimental group

Description:

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.

Treatment:

Drug: Galcanezumab

Drug: Erenumab

Drug: Fremanezumab

Onabotulinumtoxin-A

Experimental group

Description:

Onabotulinumtoxin-A will be administered via intramuscular (IM) injection on Day 0 and Day 84.

Treatment:

Drug: Onabotulinumtoxin-A