Real World Effectiveness of Eptinezumab in Participants With Migraine

NCT05284019 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: 19766N
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 10

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.

Conditions

Migraine

Outcome Measures

Primary Outcomes (8)

• 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

• 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

• 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

• Health Care Resources Utilization (HCRU): Number of Participants Who Used Health Services and Medications

  Up to Week 24

• 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

• 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

• 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

• Percentage of Participants That Switch From the Preventive Medication They Are Randomized to at Baseline to Another Preventive Medication

  Week 24

Study Arms (3)

Eptinezumab

EXPERIMENTAL

Participants will receive eptinezumab via intravenous (IV) infusion on Day 0 and Day 84.

Drug: Eptinezumab

Anti-CGRP injectables

EXPERIMENTAL

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.

Drug: Erenumab; Drug: Fremanezumab; Drug: Galcanezumab

Onabotulinumtoxin-A

EXPERIMENTAL

Onabotulinumtoxin-A will be administered via intramuscular (IM) injection on Day 0 and Day 84.

Drug: Onabotulinumtoxin-A

Interventions

Eptinezumab DRUG

Concentrate for solution for IV infusion

Also known as: Vyepti

Eptinezumab

Erenumab DRUG

Solution for SC Injection

Also known as: Aimovig®

Anti-CGRP injectables

Onabotulinumtoxin-A DRUG

Solution for IM Injection

Onabotulinumtoxin-A

Fremanezumab DRUG

Solution for SC Injection

Also known as: Ajovy®

Anti-CGRP injectables

Galcanezumab DRUG

Solution for SC Injection

Also known as: Emgality®

Anti-CGRP injectables

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• H. Lundbeck A/S: lead

Study Sites (10)

Gilbert Neurology Partners/ CCT Research

Gilbert, Arizona, 85297, United States

Location

Ki Clinical Research LLC, dba New England Institute for Clinical Research

Stamford, Connecticut, 06905, United States

Location

Innovation Medical Group

Palmetto Bay, Florida, 33157, United States

Location

The Headache Center

Ridgeland, Mississippi, 39157, United States

Location

StudyMetrix Research

City of Saint Peters, Missouri, 63303, United States

Location

North Kansas City Hospital

North Kansas City, Missouri, 64416, United States

Location

Dent Neurologic Institute - Amherst

Amherst, New York, 14226, United States

Location

Carolina Women's Research and Wellness Center

Durham, North Carolina, 27713, United States

Location

AIM Trials, LLC

Plano, Texas, 75093, United States

Location

Olympus Family Medicine/CCT Research

Salt Lake City, Utah, 84117, United States

Location

MeSH Terms

Conditions

Migraine Disorders

Interventions

eptinezumab; erenumab; Botulinum Toxins, Type A; fremanezumab; galcanezumab

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Limitations and Caveats

The study was terminated early due to enrolment challenges.

Results Point of Contact

• Title: Email contact via
• Organization: H. Lundbeck A/S

LundbeckClinicalTrials@Lundbeck.com

+4536301311

Study Officials

• Email contact via H. Lundbeck A/S

  LundbeckClinicalTrials@Lundbeck.com

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2022
• First Posted: March 17, 2022
• Study Start: March 4, 2022
• Primary Completion: February 17, 2023
• Study Completion: April 14, 2023
• Last Updated: May 29, 2024
• Results First Posted: May 29, 2024

Record last verified: 2024-05

Locations

US (10)