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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lu AG09222 High Dose | Experimental | Participants will receive a single high dose of Lu AG09222 by intravenous (IV) infusion. |
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| Lu AG09222 Low Dose | Experimental | Participants will receive a single low dose of Lu AG09222 by IV infusion. |
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| Placebo | Placebo Comparator | Participants will receive a single dose of placebo matching to Lu AG09222 by IV infusion. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lu AG09222 | Drug | Lu AG09222 will be administered per schedule specified in the arm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Number of Monthly Migraine Days (MMDs) | 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:
| Baseline, Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With ≥50% Reduction From Baseline in MMDs | 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:
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Email contact via H. Lundbeck A/S | H. Lundbeck A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Excell Research - ClinEdge - PPDS | Oceanside | California | 92056-4515 | United States | ||
| UNISON Clinical Trials (Shahram Jacobs md inc.) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39231342 | Derived | Ashina M, Phul R, Khodaie M, Lof E, Florea I. A Monoclonal Antibody to PACAP for Migraine Prevention. N Engl J Med. 2024 Sep 5;391(9):800-809. doi: 10.1056/NEJMoa2314577. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lu AG09222 High Dose | Participants received a single dose of Lu AG09222 by intravenous (IV) infusion. |
| FG001 | Lu AG09222 Low Dose | Participants received a single dose of Lu AG09222 by IV infusion. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 11, 2022 | Jan 15, 2024 |
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| Placebo | Drug | Placebo matching to Lu AG09222 will be administered per schedule specified in the arm. |
|
| Baseline, Week 4 |
| Change From Baseline in the Number of Monthly Headache Days (MHDs) | A Headache Day was defined as a day with a headache that lasted ≥30 minutes or that meets the definition of a Migraine Day. | Baseline, Week 4 |
| Sherman Oaks |
| California |
| 91403 |
| United States |
| Allied Biomedical Research Institute | Miami | Florida | 33155-4630 | United States |
| CCR Ostrava s.r.o. | Ostrava | Moravian-Silesian Region | 702 00 | Czechia |
| Mestska nemocnice Ostrava, p.o. | Ostrava | Moravian-Silesian Region | 728 80 | Czechia |
| CCR Czech | Pardubice | Pardubice Region | 530 02 | Czechia |
| CCR Prague s.r.o. | Prague | Praha, Hlavní Mesto | 130 00 | Czechia |
| Fakultni nemocnice u sv. Anny v Brne | Brno | South Moravian | 656 91 | Czechia |
| NEUROHK, s.r.o. | Choceň | 565 01 | Czechia |
| FORBELI s.r.o. | Prague | 160 00 | Czechia |
| INEP Medical s.r.o. | Prague | 186 00 | Czechia |
| CLINTRIAL s.r.o. | Prague | Czechia |
| Rigshospitalet Glostrup-Nordre Ringvej 57 | Glostrup Municipality | Capital | 2600 | Denmark |
| Aarhus Universitetshospital | Aarhus N | Central Jutland | 8200 | Denmark |
| Ltd Israel-Georgia Medical Research Clinic Helsicore | Tbilisi | 0112 | Georgia |
| Archangel St Michael Multiprofile Clinical Hospital Ltd | Tbilisi | 0159 | Georgia |
| Aversi Clinic LTD | Tbilisi | 0160 | Georgia |
| LTD MediClubGeorgia | Tbilisi | 0160 | Georgia |
| Malkhaz Katsiashvili Multiprofile Emergency Medicine Center | Tbilisi | 0172 | Georgia |
| Ltd Multiprofile Clinic "Consilium Medulla" | Tbilisi | 0186 | Georgia |
| Solumed SC | Poznan | Greater Poland Voivodeship | 60-101 | Poland |
| Pratia MCM | Krakow | Lesser Poland Voivodeship | 30-510 | Poland |
| Instytut Zdrowia Dr Boczarska-Jedynak | Oświęcim | Lesser Poland Voivodeship | 32-600 | Poland |
| ETG Singua - PPDS | Warsaw | Masovian Voivodeship | 02-777 | Poland |
| Centrum Medyczne Silmedic Sp z o o | Katowice | Silesian Voivodeship | 40-282 | Poland |
| MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak | Wroclaw | 52-210 | Poland |
| MUDr. Beata Dupejova, Neurologicka ambulancia, s.r.o. | Banská Bystrica | 974 04 | Slovakia |
| KONZILIUM s.r.o | Dubnica nad Váhom | 018 41 | Slovakia |
| FG002 | Placebo | Participants received a single dose of placebo matching to Lu AG09222 by IV infusion. |
| Received at Least 1 Dose of Study Drug |
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| COMPLETED |
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| NOT COMPLETED |
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The all-participants-treated set (APTS) represents all randomized participants who received an infusion of investigational medicinal product
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| ID | Title | Description |
|---|---|---|
| BG000 | Lu AG09222 High Dose | Participants received a single dose of Lu AG09222 by intravenous (IV) infusion. |
| BG001 | Lu AG09222 Low Dose | Participants received a single dose of Lu AG09222 by IV infusion. |
| BG002 | Placebo | Participants received a single dose of placebo matching to Lu AG09222 by IV infusion. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in the Number of Monthly Migraine Days (MMDs) | 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:
| The APTS represents all randomized participants who received an infusion of investigational medicinal product | Posted | Least Squares Mean | Standard Error | days | Baseline, Week 4 |
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| Secondary | Percentage of Participants With ≥50% Reduction From Baseline in MMDs | 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:
| The APTS represents all randomized participants who received an infusion of investigational medicinal product | Posted | Number | percentage of participants | Baseline, Week 4 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Number of Monthly Headache Days (MHDs) | A Headache Day was defined as a day with a headache that lasted ≥30 minutes or that meets the definition of a Migraine Day. | The APTS represents all randomized participants who received an infusion of investigational medicinal product. Here, 'Number of participants analyzed" signifies participants evaluable for this outcome measure. | Posted | Least Squares Mean | Standard Error | days | Baseline, Week 4 |
|
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Up to 12 weeks
The APTS represents all randomized participants who received an infusion of investigational medicinal product
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lu AG09222 High Dose | Participants received a single dose of Lu AG09222 by intravenous (IV) infusion. | 0 | 97 | 1 | 97 | 18 | 97 |
| EG001 | Lu AG09222 Low Dose | Participants received a single dose of Lu AG09222 by IV infusion. | 0 | 46 | 0 | 46 | 4 | 46 |
| EG002 | Placebo | Participants received a single dose of placebo matching to Lu AG09222 by IV infusion. | 0 | 94 | 0 | 94 | 8 | 94 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sympathetic Posterior Cervical Syndrome | Musculoskeletal and connective tissue disorders | MedDRA v25.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Covid-19 | Infections and infestations | MedDRA v25.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA v25.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v25.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Email contact via | H. Lundbeck A/S | +4536301311 | LundbeckClinicalTrials@Lundbeck.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 29, 2023 | Jan 15, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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Participants received a single dose of placebo matching to Lu AG09222 by IV infusion. |
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