Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of Lu AG09222 for the Prevention of Migraine in Patients With Unsuccessful Prior Preventive Treatments
Overview
- Phase
- Phase 2
- Intervention
- Lu AG09222
- Conditions
- Migraine
- Sponsor
- H. Lundbeck A/S
- Enrollment
- 237
- Locations
- 28
- Primary Endpoint
- Change From Baseline in the Number of Monthly Migraine Days (MMDs)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Researchers are trying to learn whether a drug called Lu AG09222 can help prevent migraine headaches for people who have not been helped by other treatments that are used to prevent migraines.
People who join this trial have tried 2 to 4 other medications to prevent their migraines, but these medications have not helped them.
When the trial is over, researchers will use this information to find out if the number of migraine days decreased more for the participants who got either dose of Lu AG09222 than for the participants who got the placebo.
Detailed Description
Participants will be randomly allocated to one of 3 treatment groups: Lu AG09222 high dose, Lu AG09222 low dose, or placebo, in a ratio of 2:1:2.
Investigators
Eligibility Criteria
Inclusion Criteria
- •The participant has a diagnosis of migraine as defined by International Classification of Headache Disorders Third Edition (ICHD-3) guidelines confirmed at the Screening Visit.
- •The participant has a history of migraine onset at least 12 months prior to the Screening Visit.
- •The participant has a migraine onset at ≤50 years of age.
- •The participant has documented evidence of treatment failure in the past 10 years of at least 2 to 4 (maximum) different migraine preventive medications.
Exclusion Criteria
- •The participant has been previously dosed with an anti-pituitary adenylate cyclase-activating polypeptide (anti-PACAP) ligand-targeting antibody.
- •The participant has confounding and clinically significant pain syndromes.
- •The participant has a diagnosis of acute or active temporomandibular disorder.
- •The participant has a history or diagnosis of confounding headaches.
Arms & Interventions
Lu AG09222 High Dose
Participants will receive a single high dose of Lu AG09222 by intravenous (IV) infusion.
Intervention: Lu AG09222
Lu AG09222 Low Dose
Participants will receive a single low dose of Lu AG09222 by IV infusion.
Intervention: Lu AG09222
Placebo
Participants will receive a single dose of placebo matching to Lu AG09222 by IV infusion.
Intervention: Placebo
Outcomes
Primary Outcomes
Change From Baseline in the Number of Monthly Migraine Days (MMDs)
Time Frame: Baseline, Week 4
The Migraine Day definition was based on the International Headache Society (IHS) guidelines for controlled trials of preventive treatment of chronic migraine and episodic migraine in adults. A Migraine Day was defined as a day with a headache that: * lasts ≥4 hours and meets International Classification of Headache Disorders Third Edition (ICHD-3) guidelines criteria C and D for migraine without aura * or lasts ≥30 minutes and where the participant had an aura with the headache (migraine with aura), * or lasts ≥30 minutes and meets two of the three ICHD-3 criteria B (without the condition on 72 hours), C and D for migraine without aura (probable migraine), * or a day with a headache that is successfully treated with a triptan, ergotamine, or other migraine-specific acute medication
Secondary Outcomes
- Change From Baseline in the Number of Monthly Headache Days (MHDs)(Baseline, Week 4)
- Percentage of Participants With ≥50% Reduction From Baseline in MMDs(Baseline, Week 4)