A Trial Investigating Lu AG09222 With Ubrogepant in Participants With Migraine
Part of paid clinical trials in Orlando, Florida.
- Sponsor
- H. Lundbeck A/S
- Study ID
- NCT06578585
- Phase
- PHASE1
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 65 Years
- Healthy Volunteers
- Not accepted
Interventions
- Ubrogepant — DRUGTablet
- Lu AG09222 — DRUGSolution for injection/infusion
- Placebo — DRUGSolution for injection/infusion
Study Details
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.
Key Dates
- Start date
- Sep 13, 2024
- Status verified
- Oct 2025
- Primary completion
- Jul 11, 2025
- Completion
- Jul 11, 2025
Study Design
- Enrollment
- 43 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Ubrogepant with Lu AG09222Participants will receive 2 doses of ubrogepant, then participants will receive Lu AG09222 followed by additional doses of ubrogepant.
- Placebo Comparator: Ubrogepant with PlaceboParticipants will receive 2 doses of ubrogepant, then participants will receive placebo followed by additional doses of ubrogepant.
Primary Outcome Measure
Number of participants with treatment-emergent adverse events (TEAEs) [ Time Frame: Up to 92 Days ]
Locations (4)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Clinical Neuroscience Solutions | Orlando | Florida | 32801 | - |
| NeuroTrials Research | Atlanta | Georgia | 30328 | - |
| Future Search Trials | Austin | Texas | 78731 | - |
| Elevate Clinical Research | Seabrook | Texas | 77586 | - |
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