Real World Effectiveness of Eptinezumab in Participants With Migraine

Migraine Clinical Trial

— EVEC  

Official title:

An Exploratory, Prospective, Randomized, Pragmatic Open Label Cohort Study to Evaluate the Comparative Effectiveness of Eptinezumab in the United States

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05284019
• Other study ID #: 19766N
• Status: Terminated
• Phase: Phase 4
• Start date: March 4, 2022
• Est. completion date: April 14, 2023

Study information

• Verified date: May 2024
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 32
• Est. completion date: April 14, 2023
• Est. primary completion date: February 17, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Drug:
• 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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Patient-informed Most Bothersome Symptom (PI-MBS) Score at Week 24	Participants select the symptom that they find most impairs them at the time of reporting and rate the severity of that symptom on a 7-point scale (1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse) where a high score indicated worsening. Score ranges from 1 (Very Much Improved) to 7 (Very Much Worse). Lower scores indicate better health status. The MBS areas included: nausea, vomiting, sensitivity to light, sensitivity to sound, mental cloudiness, fatigue, pain with activity, mood changes, and other symptoms.	Baseline, Week 24
Primary	Number of "Good Days" From Baseline	The participants report the number of "good days" and "bad days" they had in the previous week on a weekly basis using the good day/bad day scale.	Up to Week 24
Primary	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	The EQ-5D-5L is a participant-reported assessment designed to measure the participant's well-being. It consists of 5 descriptive items (mobility, self-care, usual activities, pain/discomfort, and depression/anxiety) and a visual analog scale (VAS) of the overall health state. Each descriptive item is rated on a 5-point index ranging from 1 (no problems) to 5 (extreme problems). The VAS ranges from 0 (worst imaginable health state) to 100 (best imaginable health state).	Baseline, Week 24
Primary	Health Care Resources Utilization (HCRU): Number of Participants Who Used Health Services and Medications		Up to Week 24
Primary	QOL as Measured by the 6 Item Headache Impact Test (HIT-6) Score	The HIT-6 (version 1.0) is a Likert-type, self-reporting questionnaire designed to assess the impact of an occurring headache and its effect on the ability to function normally in daily life. The HIT-6 contains 6 questions, each item is rated from never to always with the following response scores: never = 6, rarely = 8, sometimes = 10, very often = 11, and always = 13. The total score for the HIT-6 is the sum of each response score ranging from 36 to 78. The life impact derived from the total score is described as follows: severe (=60), substantial (56-59), some (50-55), little to none (=49).	Up to Week 24
Primary	QOL as Measured by the Migraine Disability Assessment (MIDAS) Total Score	The Midas score is a participant completed 5-item questionnaire about lost time and productivity (for work, school or family/social activities) in the past 3 months (number of days missed) where: 0-5=Little or No disability, 6-10=Mild disability, 11-20=Moderate disability or 21+ Severe disability.	Up to Week 24
Primary	Participant Satisfaction Score as Measured by the Treatment Satisfaction Questionnaire for Medication (TSQM)	The TSQM assesses four domains of participants' satisfaction with treatment, with scale ranges from 0 (extremely dissatisfied) to 100 (not at all dissatisfied) for each of the categories (Effectiveness, Side Effects, Convenience, and Overall Satisfaction).	Week 24
Primary	Percentage of Participants That Switch From the Preventive Medication They Are Randomized to at Baseline to Another Preventive Medication		Week 24