Status:
TERMINATED
Real World Effectiveness of Eptinezumab in Participants With Migraine
Lead Sponsor:
H. Lundbeck A/S
Conditions:
Migraine
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 4 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 14 2023
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT05284019
Start Date
March 4 2022
End Date
April 14 2023
Last Update
May 29 2024
Active Locations (10)
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1
Gilbert Neurology Partners/ CCT Research
Gilbert, Arizona, United States, 85297
2
Ki Clinical Research LLC, dba New England Institute for Clinical Research
Stamford, Connecticut, United States, 06905
3
Innovation Medical Group
Palmetto Bay, Florida, United States, 33157
4
The Headache Center
Ridgeland, Mississippi, United States, 39157