Investigating a new migraine treatment combining Lu AG09222 and ubrogepant
Interventional, Randomized, Double-blind, Placebo-controlled Trial Investigating the Safety and Tolerability of Lu AG09222 When Coadministered With Ubrogepant in Participants With Migraine
This study is testing a new migraine treatment that combines an injection of Lu AG09222 with oral ubrogepant to see if it helps people with migraines feel better.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | H. Lundbeck A/S Industry-sponsored |
| Locations | 4 sites (Orlando, Florida and 3 other locations) |
| Trial ID | NCT06578585 on ClinicalTrials.gov |
What this trial studies
This trial aims to evaluate the safety and tolerability of Lu AG09222 when administered alongside ubrogepant in individuals diagnosed with migraine. Participants will receive either Lu AG09222 or a placebo through injection, along with oral ubrogepant tablets. The study will monitor any new or worsening medical issues that arise during the treatment period. It is designed to gather important data on the combined effects of these medications on migraine management.
Who should consider this trial
Good fit: Ideal candidates are adults with a confirmed diagnosis of migraine who experience at least two migraine days per month.
Not a fit: Patients who have previously received anti-PACAP treatments or are currently pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment combination could provide a new effective option for managing migraine symptoms.
How similar studies have performed: While this specific combination has not been extensively tested, similar approaches in migraine treatment have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * The participant has a diagnosis of migraine as defined by ICHD-3 guidelines confirmed at the Screening Visit. * The participant has a history of migraine onset ≥12 months prior to the Screening Visit. * The participant has ≥2 migraine days and headache occurring on \<15 days per month for each month within the past 3 months prior to the Screening Visit. * The participant has a body mass index (BMI) ≥18.5 and ≤ 35 kilograms per meter squared (kg/m\^2) at the Screening Visit. Exclusion Criteria: * The participant has previously been dosed with an anti-pituitary adenylate cyclase-activating peptide (PACAP) treatment. * The participant has participated in a clinical trial \<30 days prior to the Screening Visit. * The participant has taken any investigational medicinal product (IMP) \<3 months or \<5 half-lives of that product, whichever is longer, prior to Visit 1. * The participant is pregnant, breastfeeding, intends to become pregnant, or is of childbearing potential and not willing to use adequate contraceptive methods. * The participant has known or suspected hypersensitivity or intolerance to the IMP, auxiliary medicinal product (AxMP), or their excipients. Note: Other inclusion and exclusion criteria may apply.
Where this trial is running
Orlando, Florida and 3 other locations
- Clinical Neuroscience Solutions — Orlando, Florida, United States (Recruiting)
- NeuroTrials Research — Atlanta, Georgia, United States (Recruiting)
- Future Search Trials — Austin, Texas, United States (Recruiting)
- Elevate Clinical Research — Seabrook, Texas, 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.