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

NCT05133323 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 19678A
• Study Type: interventional
• Target: 237
• Locations: 6 countries
• Sites: 28

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.

Conditions

Migraine

Outcome Measures

Primary Outcomes (1)

• 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: * 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

  Baseline, Week 4

Secondary Outcomes (2)

• Percentage of Participants With ≥50% Reduction From Baseline in MMDs

  Baseline, Week 4

• Change From Baseline in the Number of Monthly Headache Days (MHDs)

  Baseline, Week 4

Study Arms (3)

Lu AG09222 High Dose

EXPERIMENTAL

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

Drug: Lu AG09222

Lu AG09222 Low Dose

EXPERIMENTAL

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

Drug: Lu AG09222

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Lu AG09222 DRUG

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

Lu AG09222 High Dose; Lu AG09222 Low Dose

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• H. Lundbeck A/S: lead

Study Sites (28)

Excell Research - ClinEdge - PPDS

Oceanside, California, 92056-4515, United States

Location

UNISON Clinical Trials (Shahram Jacobs md inc.)

Sherman Oaks, California, 91403, United States

Location

Allied Biomedical Research Institute

Miami, Florida, 33155-4630, United States

Location

CCR Ostrava s.r.o.

Ostrava, Moravskoslezský kraj, 702 00, Czechia

Location

Mestska nemocnice Ostrava, p.o.

Ostrava, Moravskoslezský kraj, 728 80, Czechia

Location

CCR Czech

Pardubice, Pardubický kraj, 530 02, Czechia

Location

CCR Prague s.r.o.

Prague, Praha, Hlavní Mesto, 130 00, Czechia

Location

Fakultni nemocnice u sv. Anny v Brne

Brno, South Moravian, 656 91, Czechia

Location

NEUROHK, s.r.o.

Choceň, 565 01, Czechia

Location

FORBELI s.r.o.

Prague, 160 00, Czechia

Location

INEP Medical s.r.o.

Prague, 186 00, Czechia

Location

CLINTRIAL s.r.o.

Prague, Czechia

Location

Rigshospitalet Glostrup-Nordre Ringvej 57

Glostrup Municipality, Capital, 2600, Denmark

Location

Aarhus Universitetshospital

Aarhus N, Central Jutland, 8200, Denmark

Location

Ltd Israel-Georgia Medical Research Clinic Helsicore

Tbilisi, 0112, Georgia

Location

Archangel St Michael Multiprofile Clinical Hospital Ltd

Tbilisi, 0159, Georgia

Location

Aversi Clinic LTD

Tbilisi, 0160, Georgia

Location

LTD MediClubGeorgia

Tbilisi, 0160, Georgia

Location

Malkhaz Katsiashvili Multiprofile Emergency Medicine Center

Tbilisi, 0172, Georgia

Location

Ltd Multiprofile Clinic "Consilium Medulla"

Tbilisi, 0186, Georgia

Location

Solumed SC

Poznan, Greater Poland Voivodeship, 60-101, Poland

Location

Pratia MCM

Krakow, Lesser Poland Voivodeship, 30-510, Poland

Location

Instytut Zdrowia Dr Boczarska-Jedynak

Oświęcim, Lesser Poland Voivodeship, 32-600, Poland

Location

ETG Singua - PPDS

Warsaw, Masovian Voivodeship, 02-777, Poland

Location

Centrum Medyczne Silmedic Sp z o o

Katowice, Silesian Voivodeship, 40-282, Poland

Location

MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak

Wroclaw, 52-210, Poland

Location

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

Banská Bystrica, 974 04, Slovakia

Location

KONZILIUM s.r.o

Dubnica nad Váhom, 018 41, Slovakia

Location

Related Publications (1)

• 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.

  PMID: 39231342 DERIVED

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Email contact via
• Organization: H. Lundbeck A/S

LundbeckClinicalTrials@Lundbeck.com

+4536301311

Study Officials

• Email contact via H. Lundbeck A/S

  H. Lundbeck A/S

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2021
• First Posted: November 24, 2021
• Study Start: November 11, 2021
• Primary Completion: January 19, 2023
• Study Completion: March 16, 2023
• Last Updated: March 13, 2024
• Results First Posted: February 8, 2024

Record last verified: 2024-03

Locations

US (3); CZ (9); DK (2); SL (2); GE (6); PL (6)