A Study With Lu AG09222 in Adults With Migraine Who Have Not Been Helped by Prior Preventive Treatments
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Lu AG09222 High Dose Participants will receive a single high dose of Lu AG09222 by intravenous (IV) infusion. |
Drug: Lu AG09222
Lu AG09222 will be administered per schedule specified in the arm.
|
| Experimental: Lu AG09222 Low Dose Participants will receive a single low dose of Lu AG09222 by IV infusion. |
Drug: Lu AG09222
Lu AG09222 will be administered per schedule specified in the arm.
|
| Placebo Comparator: Placebo Participants will receive a single dose of placebo matching to Lu AG09222 by IV infusion. |
Drug: Placebo
Placebo matching to Lu AG09222 will be administered per schedule specified in the arm.
|
Outcome Measures
Primary Outcome Measures
- Change From Baseline in the Number of Monthly Migraine Days (MMDs) at Month 1 (Weeks 1-4) [Baseline, Month 1 (Weeks 1-4)]
Secondary Outcome Measures
- Percentage of Participants With ≥50% Reduction From Baseline in MMDs [Baseline up to Month 1 (Weeks 1-4)]
- Change From Baseline in the Number of Monthly Headache Days (MHDs) at Month 1 (Weeks 1-4) [Baseline, Month 1 (Weeks 1-4)]
Eligibility Criteria
Criteria
Key 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.
Key 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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Excell Research - ClinEdge - PPDS | Oceanside | California | United States | 92056-4515 |
| 2 | UNISON Clinical Trials (Shahram Jacobs md inc.) | Sherman Oaks | California | United States | 91403 |
| 3 | Allied Biomedical Research Institute | Miami | Florida | United States | 33155-4630 |
| 4 | Fakultni nemocnice u sv. Anny v Brne | Brno | Jihomoravsky Kraj | Czechia | 656 91 |
| 5 | CCR Ostrava s.r.o. | Ostrava | Moravskoslezsky Kraj | Czechia | 702 00 |
| 6 | Mestska nemocnice Ostrava, p.o. | Ostrava | Moravskoslezsky Kraj | Czechia | 728 80 |
| 7 | CCR Czech | Pardubice | Pardubicky Kraj | Czechia | 530 02 |
| 8 | CCR Prague s.r.o. | Praha | Praha, Hlavní Mesto | Czechia | 130 00 |
| 9 | NEUROHK, s.r.o. | Chocen | Czechia | 565 01 | |
| 10 | CLINTRIAL s.r.o. | Prague | Czechia | ||
| 11 | FORBELI s.r.o. | Praha 6 | Czechia | 160 00 | |
| 12 | INEP Medical s.r.o. | Praha 8 | Czechia | 186 00 | |
| 13 | Rigshospitalet - Glostrup | Glostrup | Capital | Denmark | 2600 |
| 14 | Aarhus Universitetshospital | Aarhus N | Central Jutland | Denmark | 8200 |
| 15 | Ltd Israel-Georgia Medical Research Clinic Helsicore | Tbilisi | Georgia | 0112 | |
| 16 | Archangel St Michael Multiprofile Clinical Hospital Ltd | Tbilisi | Georgia | 0159 | |
| 17 | Aversi Clinic LTD | Tbilisi | Georgia | 0160 | |
| 18 | LTD MediClubGeorgia | Tbilisi | Georgia | 0160 | |
| 19 | Malkhaz Katsiashvili Multiprofile Emergency Medicine Center | Tbilisi | Georgia | 0172 | |
| 20 | Ltd Multiprofile Clinic "Consilium Medulla" | Tbilisi | Georgia | 0186 | |
| 21 | Pratia MCM | Krakow | Malopolskie | Poland | 30-510 |
| 22 | Instytut Zdrowia Dr Boczarska-Jedynak | Oswiecim | Malopolskie | Poland | 32-600 |
| 23 | ETG Singua - PPDS | Warszawa | Mazowieckie | Poland | 02-777 |
| 24 | Centrum Medyczne Silmedic Sp z o o | Katowice | Slaskie | Poland | 40-282 |
| 25 | Solumed SC | Poznan | Wielkopolskie | Poland | 60-101 |
| 26 | Pracownia Badan Klinicznych Salus M. Golabek, A. Gryglas-Dworak Sp. J. | Wroclaw | Poland | 52-210 | |
| 27 | MUDr. Beata Dupejova, Neurologicka ambulancia, s.r.o. | Banska Bystrica | Slovakia | 974 04 | |
| 28 | KONZILIUM s.r.o | Dubnica nad Vahom | Slovakia | 018 41 |
Sponsors and Collaborators
- H. Lundbeck A/S
Investigators
- Study Director: Email contact via H. Lundbeck A/S, H. Lundbeck A/S
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 19678A