A Study With Lu AG09222 in Adults With Migraine Who Have Not Been Helped by Prior Preventive Treatments

NCT ID: NCT05133323

Last Updated: 2024-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 237 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-11
• Study Completion Date: 2023-03-16

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.

Conditions

Migraine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Lu AG09222 High Dose

Participants will receive a single high dose of Lu AG09222 by intravenous (IV) infusion.

Group Type: EXPERIMENTAL

Lu AG09222

Intervention Type: DRUG

Lu AG09222 will be administered per schedule specified in the arm.

Lu AG09222 Low Dose

Participants will receive a single low dose of Lu AG09222 by IV infusion.

Group Type: EXPERIMENTAL

Lu AG09222

Intervention Type: DRUG

Lu AG09222 will be administered per schedule specified in the arm.

Placebo

Participants will receive a single dose of placebo matching to Lu AG09222 by IV infusion.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo matching to Lu AG09222 will be administered per schedule specified in the arm.

Interventions

Lu AG09222

Lu AG09222 will be administered per schedule specified in the arm.

Intervention Type: DRUG

Placebo

Placebo matching to Lu AG09222 will be administered per schedule specified in the arm.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

H. Lundbeck A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Email contact via H. Lundbeck A/S

Role: STUDY_DIRECTOR

H. Lundbeck A/S

Locations

Excell Research - ClinEdge - PPDS

Oceanside, California, United States

UNISON Clinical Trials (Shahram Jacobs md inc.)

Sherman Oaks, California, United States

Allied Biomedical Research Institute

Miami, Florida, United States

CCR Ostrava s.r.o.

Ostrava, Moravskoslezský kraj, Czechia

Mestska nemocnice Ostrava, p.o.

Ostrava, Moravskoslezský kraj, Czechia

CCR Czech

Pardubice, Pardubický kraj, Czechia

CCR Prague s.r.o.

Prague, Praha, Hlavní Mesto, Czechia

Fakultni nemocnice u sv. Anny v Brne

Brno, South Moravian, Czechia

NEUROHK, s.r.o.

Choceň, , Czechia

FORBELI s.r.o.

Prague, , Czechia

INEP Medical s.r.o.

Prague, , Czechia

CLINTRIAL s.r.o.

Prague, , Czechia

Rigshospitalet Glostrup-Nordre Ringvej 57

Glostrup Municipality, Capital, Denmark

Aarhus Universitetshospital

Aarhus N, Central Jutland, Denmark

Ltd Israel-Georgia Medical Research Clinic Helsicore

Tbilisi, , Georgia

Archangel St Michael Multiprofile Clinical Hospital Ltd

Tbilisi, , Georgia

Aversi Clinic LTD

Tbilisi, , Georgia

LTD MediClubGeorgia

Tbilisi, , Georgia

Malkhaz Katsiashvili Multiprofile Emergency Medicine Center

Tbilisi, , Georgia

Ltd Multiprofile Clinic "Consilium Medulla"

Tbilisi, , Georgia

Solumed SC

Poznan, Greater Poland Voivodeship, Poland

Pratia MCM

Krakow, Lesser Poland Voivodeship, Poland

Instytut Zdrowia Dr Boczarska-Jedynak

Oświęcim, Lesser Poland Voivodeship, Poland

ETG Singua - PPDS

Warsaw, Masovian Voivodeship, Poland

Centrum Medyczne Silmedic Sp z o o

Katowice, Silesian Voivodeship, Poland

MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak

Wroclaw, , Poland

MUDr. Beata Dupejova, Neurologicka ambulancia, s.r.o.

Banská Bystrica, , Slovakia

KONZILIUM s.r.o

Dubnica nad Váhom, , Slovakia

Countries

United States; Czechia; Denmark; Georgia; Poland; Slovakia

References

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.

Reference Type: DERIVED

PMID: 39231342 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

19678A

Identifier Type: -

Identifier Source: org_study_id