Eptinezumab for Migraine Patients Not Responding to Other Treatments
Interventional, Open-label Trial, Investigating the Effectiveness of Eptinezumab in Participants With Migraine and Previous Inadequate Response to CGRP-targeting Therapies
This study is testing if eptinezumab can help people with migraines who haven't found relief from other treatments feel better and improve their quality of life.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | H. Lundbeck A/S Industry-sponsored |
| Drugs / interventions | eptinezumab |
| Locations | 1 site (Canton, Ohio) |
| Trial ID | NCT06701526 on ClinicalTrials.gov |
What this trial studies
This trial aims to evaluate the effectiveness of eptinezumab in improving migraine symptoms and quality of life for individuals who have not experienced sufficient relief from previous anti-CGRP therapies. Participants must have a history of migraines for at least 12 months and experience at least 8 migraine days per month. The study will assess the response to eptinezumab in those who have previously shown inadequate response to other CGRP-targeting medications. The trial is interventional and is classified as Phase 4.
Who should consider this trial
Good fit: Ideal candidates are adults with a diagnosis of migraine who have experienced insufficient response to at least one anti-CGRP monoclonal antibody or gepant.
Not a fit: Patients who have had inadequate responses to multiple CGRP-targeting therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide significant relief for migraine patients who have not benefited from existing therapies.
How similar studies have performed: Other studies have shown promise with CGRP-targeting therapies, but this specific approach with eptinezumab in this patient population is less explored.
Eligibility criteria
Show full inclusion / exclusion criteria
Key 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.
Where this trial is running
Canton, Ohio
- Neuroscience Research Center, LLC — Canton, Ohio, United States (Recruiting)
Study contacts
- Study coordinator: Email contact via H. Lundbeck A/S
- Email: LundbeckClinicalTrials@Lundbeck.com
- Phone: +45 36301311
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.