Real World Effectiveness of Eptinezumab in Participants With Migraine

Stopped early · Phase 4

Conditions studied: Migraine

In brief

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.

Key facts

Study ID

NCT05284019

Run by

H. Lundbeck A/S

People needed

32

Starts

2022-03-04

Expected to finish

2023-04-14

Last updated by the study team

2024-05-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Gilbert Neurology Partners/ CCT Research — Gilbert, Arizona, United States
• Ki Clinical Research LLC, dba New England Institute for Clinical Research — Stamford, Connecticut, United States
• Innovation Medical Group — Palmetto Bay, Florida, United States
• The Headache Center — Ridgeland, Mississippi, United States
• StudyMetrix Research — City of Saint Peters, Missouri, United States
• North Kansas City Hospital — North Kansas City, Missouri, United States
• Dent Neurologic Institute - Amherst — Amherst, New York, United States
• Carolina Women's Research and Wellness Center — Durham, North Carolina, United States
• AIM Trials, LLC — Plano, Texas, United States
• Olympus Family Medicine/CCT Research — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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