Clinical trial NCT05284019: Real World Effectiveness of Eptinezumab in Participants With Migraine
Official title: An Exploratory, Prospective, Randomized, Pragmatic Open Label Cohort Study to Evaluate the Comparative Effectiveness of Eptinezumab in the United States
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Migraine
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2022-03-17
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 migraine (CM). These objectives include exploring the comparative effectiveness on patient reported outcomes.


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.

Primary outcomes:
measure: Change From Baseline in Patient-informed Most Bothersome Symptom (PI-MBS) Score at Week 24
timeFrame: Baseline, Week 24
measure: Number of "Good Days" From Baseline
timeFrame: Up to Week 24
measure: Change From Baseline in Quality of Life (QOL) as Measured by the 5 Level Euro Quality of Life 5 Dimensional Questionnaire (EQ-5D-5L) Score at Week 24
timeFrame: Baseline, Week 24
measure: Health Care Resources Utilization (HCRU): Number of Participants Who Used Health Services and Medications
timeFrame: Up to Week 24
measure: QOL as Measured by the 6 Item Headache Impact Test (HIT-6) Score
timeFrame: Up to Week 24
measure: QOL as Measured by the Migraine Disability Assessment (MIDAS) Total Score
timeFrame: Up to Week 24
measure: Participant Satisfaction Score as Measured by the Treatment Satisfaction Questionnaire for Medication (TSQM)
timeFrame: Week 24
measure: Percentage of Participants That Switch From the Preventive Medication They Are Randomized to at Baseline to Another Preventive Medication
timeFrame: Week 24
Secondary outcomes:
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Gilbert Neurology Partners/ CCT Research
state: Arizona
city: Stamford
country: United States
facility: Ki Clinical Research LLC, dba New England Institute for Clinical Research
state: Connecticut
city: Palmetto Bay
country: United States
facility: Innovation Medical Group
state: Florida
city: Ridgeland
country: United States
facility: The Headache Center
state: Mississippi
city: North Kansas City
country: United States
facility: North Kansas City Hospital
state: Missouri
city: Saint Peters
country: United States
facility: StudyMetrix Research
state: Missouri
city: Amherst
country: United States
facility: Dent Neurologic Institute - Amherst
state: New York
city: Durham
country: United States
facility: Carolina Women's Research and Wellness Center
state: North Carolina
city: Plano
country: United States
facility: AIM Trials, LLC
state: Texas
city: Salt Lake City
country: United States
facility: Olympus Family Medicine/CCT Research
state: Utah
Study officials:
affiliation: LundbeckClinicalTrials@Lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References: