A Trial of Eptinezumab in Participants With Migraine and Insufficient Response to Anti-CGRP Medications

Phase 4

Recruiting

• Conditions: Migraine
• Interventions: Drug: Eptinezumab

• Registration Number: NCT06701526
• Lead Sponsor: H. Lundbeck A/S

Brief Summary

The main goal of this trial is to learn whether eptinezumab improves migraine symptoms and quality of life of participants with migraine who did not perceive a sufficient improvement during previous treatment with therapies targeting calcitonin gene-related peptide (CGRP).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-20
• Study First Submitted QC: 2024-11-20
• Study First Posted: 2024-11-22
• Study Start: 2024-12-18
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-14
• Last Update Posted: 2025-01-15
• Primary Completion: 2026-06-05
• Study Completion: 2026-06-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• The participant has a diagnosis of migraine as defined by International Headache Society (IHS) International Classification of Headache Disorders 3rd Edition (ICHD-3) guidelines with a history of migraine of at least 12 months prior to the Screening Visit.
• The participant has ≥8 migraine days per month for each month within the past 3 months prior to the Screening Visit.
• The participant has documented evidence of recent inadequate response to either one anti-CGRP monoclonal antibody (mAb) (other than eptinezumab) or one gepant, indicated and used for migraine prevention.

Key

Exclusion Criteria

• The participant has taken more than 10 tablets of ubrogepant or more than 8 tablets of rimegepant per month as an acute migraine medication in the 1 month prior to the screening visit and during the 4-week baseline period.
• The participant has previously had an inadequate response to more than one CGRP-targeting therapy (anti-CGRP mAb or gepants), indicated for migraine prevention.
• The participant has a history of cancer, other than basal cell or stage 1 squamous cell carcinoma of the skin or adequately treated cervical intraepithelial neoplasia, that has not been in remission for >5 years prior to the first dose of eptinezumab. Male participants with abnormal prostate-specific antigen levels according to national/local guideline may be enrolled in the trial provided they have been followed up, have been asymptomatic, and have had no treatment for prostate cancer. Participants under surveillance for a low and stable level of M-component are allowed.
• The participant has previously been treated with eptinezumab.

Other protocol-defined inclusion and exclusion criteria apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Eptinezumab	Eptinezumab	Participants will receive eptinezumab at Baseline (Day 1) and Week 12

Primary Outcome Measures

Name	Time	Method
Number of Participants with Response of "Much Improved" or "Very Much Improved" on the Patient Global Impression of Change (PGIC) Scale	Week 24

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in Number of Good Days per Month	Weeks 12 and 24
Change from Baseline in Migraine Clinical Outcome Assessment System-Cognition (MiCOAS-COG) Score	Weeks 12 and 24
Number of Participants with Response of "Much Improved" or "Very Much Improved" in Brain Fog	Weeks 12 and 24
Brain Fog Score	Weeks 12 and 24
Number of Participants with Adverse Events (AEs)	Up to Week 26
CGIC Score	Weeks 12 and 24
Number of Participants with GAS Score ≥50	Weeks 12 and 24
Change from Baseline in Monthly Migraine Days (MMDs)	Weeks 1-12 and 13-24
Change from Baseline in MMDs with Use of Acute Medication	Weeks 1-12 and 13-24
Change from Baseline in Migraine Disability Assessment (MIDAS) Scores	Weeks 12 and 24
Goal Attainment Scaling (GAS) Score	Weeks 12 and 24
Change from Baseline in the Percentage of MMDs with Severe Pain Intensity	Weeks 1-12 and 13-24
Number of Participants with Response of "Much Improved" or "Very Much Improved" on the PGIC Scale	Week 12
PGIC Score	Weeks 12 and 24
Change from Baseline in Monthly Headache Days (MHDs)	Weeks 1-12 and 13-24
Number of Participants with Response of "Much Improved" or "Very Much Improved" on the Clinical Global Impression of Change (CGIC) Scale	Weeks 12 and 24

Trial Locations

Locations (1)

Neuroscience Research Center, LLC; 🇺🇸 Canton, Ohio, United States