NCT06578585CompletedPhase 1
A Trial Investigating Lu AG09222 With Ubrogepant in Participants With Migraine
Interventional, Randomized, Double-blind, Placebo-controlled Trial Investigating the Safety and Tolerability of Lu AG09222 When Coadministered With Ubrogepant in Participants With Migraine
Source: ClinicalTrials.gov · Last updated 14 Oct 2025
Brief summary (registry, in English)
The main goal of this trial is to learn more about the safety and tolerability of Lu AG09222 when taken together with ubrogepant. This includes looking for any new or worsening medical issues the participants have with the treatment. During the trial, participants with migraine will receive ubrogepant oral tablets and an injection of either Lu AG09222 or a placebo.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 43 (actual)
- First submitted
- 27 Aug 2024
- Start date
- 13 Sept 2024
- Primary completion date
- 11 Jul 2025
- Lead sponsor
- H. Lundbeck A/S
- Diseases
- Migraine
- NCT number
- NCT06578585
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 43
- From 13 Sept 2024 to the primary completion date, 11 Jul 2025
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Other
- The participant is pregnant, breastfeeding, intends to become pregnant, or is of childbearing potential and not willing to use adequate contraceptive methods.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| NeuroTrials Research Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Future Search Trials Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| Clinical Neuroscience Solutions Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| Elevate Clinical Research Coordinator of this site? Confirm its status | Seabrook | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.