Real World Effectiveness of Eptinezumab in Participants With Migraine
NCT ID: NCT05284019
Last Updated: 2024-05-29
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE4
32 participants
INTERVENTIONAL
2022-03-04
2023-04-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Eptinezumab
Participants will receive eptinezumab via intravenous (IV) infusion on Day 0 and Day 84.
Eptinezumab
Concentrate for solution for IV infusion
Anti-CGRP injectables
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.
Erenumab
Solution for SC Injection
Fremanezumab
Solution for SC Injection
Galcanezumab
Solution for SC Injection
Onabotulinumtoxin-A
Onabotulinumtoxin-A will be administered via intramuscular (IM) injection on Day 0 and Day 84.
Onabotulinumtoxin-A
Solution for IM Injection
Interventions
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Eptinezumab
Concentrate for solution for IV infusion
Erenumab
Solution for SC Injection
Onabotulinumtoxin-A
Solution for IM Injection
Fremanezumab
Solution for SC Injection
Galcanezumab
Solution for SC Injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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H. Lundbeck A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Locations
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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
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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19766N
Identifier Type: -
Identifier Source: org_study_id
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