Status:
COMPLETED
A Trial Investigating Lu AG09222 With Ubrogepant in Participants With Migraine
Lead Sponsor:
H. Lundbeck A/S
Conditions:
Migraine
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
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 part...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 13 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 11 2025
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT06578585
Start Date
September 13 2024
End Date
July 11 2025
Last Update
October 14 2025
Active Locations (4)
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