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Lu AG09222 + Ubrogepant for Migraine
Phase 1
Recruiting
Research Sponsored by H. Lundbeck A/S
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participant has a diagnosis of migraine as defined by ICHD-3 guidelines confirmed at the Screening Visit
Be older than 18 years old
Must not have
Participant has previously been dosed with an anti-pituitary adenylate cyclase-activating peptide (PACAP) treatment
Participant is pregnant, breastfeeding, intends to become pregnant, or is of childbearing potential and not willing to use adequate contraceptive methods
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Summary
This trial aims to investigate how safe and well-tolerated Lu AG09222 is when taken with ubrogepant for people with migraines. Participants will receive either Lu AG09222 or
Who is the study for?
This trial is for individuals with migraines, as defined by ICHD-3 guidelines, who've had this condition for at least a year. They should experience 2 or more migraine days monthly but less than 15 headache days per month over the last three months. Participants must have a BMI between 18.5 and ≤35 kg/m².
What is being tested?
The study aims to assess the safety of Lu AG09222 when used with ubrogepant in people with migraines. It involves taking ubrogepant tablets and getting injections of either Lu AG09222 or a placebo to see if there are any health changes.
What are the potential side effects?
Possible side effects may include new or worsening medical issues related to the treatment; however, specific side effects are not listed here.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with migraine according to ICHD-3 guidelines.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been treated with a PACAP-targeting therapy before.
Select...
I am pregnant, breastfeeding, planning to become pregnant, or not using birth control.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Ubrogepant with Lu AG09222Experimental Treatment2 Interventions
Participants will receive 2 doses of ubrogepant, then participants will receive Lu AG09222 followed by additional doses of ubrogepant.
Group II: Ubrogepant with PlaceboPlacebo Group2 Interventions
Participants will receive 2 doses of ubrogepant, then participants will receive placebo followed by additional doses of ubrogepant.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lu AG09222
2022
Completed Phase 2
~350
Ubrogepant
2016
Completed Phase 4
~4990
Find a Location
Who is running the clinical trial?
H. Lundbeck A/SLead Sponsor
331 Previous Clinical Trials
78,153 Total Patients Enrolled
15 Trials studying Migraine
4,986 Patients Enrolled for Migraine
Email contact via H. Lundbeck A/SStudy DirectorH. Lundbeck A/S
190 Previous Clinical Trials
58,635 Total Patients Enrolled
12 Trials studying Migraine
4,236 Patients Enrolled for Migraine