Clinical trial
An Exploratory, Prospective, Randomized, Pragmatic Open Label Cohort Study to Evaluate the Comparative Effectiveness of Eptinezumab in the United States
Name
19766N
Description
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.
Trial arms
Trial start
2022-03-04
Estimated PCD
2023-02-17
Trial end
2023-04-14
Status
Terminated
Phase
Early phase I
Treatment
Eptinezumab
Concentrate for solution for IV infusion
Arms:
Eptinezumab
Other names:
Vyepti
Erenumab
Solution for SC Injection
Arms:
Anti-CGRP injectables
Other names:
Aimovig®
Onabotulinumtoxin-A
Solution for IM Injection
Arms:
Onabotulinumtoxin-A
Fremanezumab
Solution for SC Injection
Arms:
Anti-CGRP injectables
Other names:
Ajovy®
Galcanezumab
Solution for SC Injection
Arms:
Anti-CGRP injectables
Other names:
Emgality®
Size
32
Primary endpoint
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
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 32, 'type': 'ACTUAL'}}
Updated at
2023-05-11
1 organization
5 products
1 indication
Organization
H. LundbeckProduct
EptinezumabIndication
MigraineProduct
ErenumabProduct
Onabotulinumtoxin-AProduct
FremanezumabProduct
Galcanezumab