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

Phase 2

Completed

• Conditions: Migraine
• Interventions: Drug: Placebo; Drug: Lu AG09222

• Registration Number: NCT05133323
• Lead Sponsor: H. Lundbeck A/S

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.

Study Timeline

• Study Start: 2021-11-11
• Study First Submitted: 2021-11-15
• Study First Submitted QC: 2021-11-15
• Study First Posted: 2021-11-24
• Primary Completion: 2023-01-19
• Study Completion: 2023-03-16
• Results First Submitted: 2024-01-15
• Results First Submitted QC: 2024-01-15
• Results First Posted: 2024-02-08
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-12
• Last Update Posted: 2024-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 237

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

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Participants will receive a single dose of placebo matching to Lu AG09222 by IV infusion.
Lu AG09222 High Dose	Lu AG09222	Participants will receive a single high dose of Lu AG09222 by intravenous (IV) infusion.
Lu AG09222 Low Dose	Lu AG09222	Participants will receive a single low dose of Lu AG09222 by IV infusion.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in the Number of Monthly Migraine Days (MMDs)	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 Outcome Measures

Name	Time	Method
Change From Baseline in the Number of Monthly Headache Days (MHDs)	Baseline, Week 4	A Headache Day was defined as a day with a headache that lasted ≥30 minutes or that meets the definition of a Migraine Day.
Percentage of Participants With ≥50% Reduction From Baseline in MMDs	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

Trial Locations

Locations (28)

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 Czech; 🇨🇿 Pardubice, Pardubicky Kraj, Czechia

Fakultni nemocnice u sv. Anny v Brne; 🇨🇿 Brno, Jihomoravsky Kraj, Czechia

CCR Ostrava s.r.o.; 🇨🇿 Ostrava, Moravskoslezsky Kraj, Czechia

Mestska nemocnice Ostrava, p.o.; 🇨🇿 Ostrava, Moravskoslezsky Kraj, Czechia

NEUROHK, s.r.o.; 🇨🇿 Chocen, Czechia

CCR Prague s.r.o.; 🇨🇿 Praha, Praha, Hlavní Mesto, Czechia

CLINTRIAL s.r.o.; 🇨🇿 Prague, Czechia

FORBELI s.r.o.; 🇨🇿 Praha 6, Czechia

INEP Medical s.r.o.; 🇨🇿 Praha 8, Czechia

Aarhus Universitetshospital; 🇩🇰 Aarhus N, Central Jutland, Denmark

LTD MediClubGeorgia; 🇬🇪 Tbilisi, Georgia

Pratia MCM; 🇵🇱 Krakow, Malopolskie, Poland

Centrum Medyczne Silmedic Sp z o o; 🇵🇱 Katowice, Slaskie, Poland

KONZILIUM s.r.o; 🇸🇰 Dubnica nad Vahom, Slovakia

ETG Singua - PPDS; 🇵🇱 Warszawa, Mazowieckie, Poland

Aversi Clinic LTD; 🇬🇪 Tbilisi, Georgia

Malkhaz Katsiashvili Multiprofile Emergency Medicine Center; 🇬🇪 Tbilisi, Georgia

Solumed SC; 🇵🇱 Poznan, Wielkopolskie, Poland

Archangel St Michael Multiprofile Clinical Hospital Ltd; 🇬🇪 Tbilisi, Georgia

Ltd Israel-Georgia Medical Research Clinic Helsicore; 🇬🇪 Tbilisi, Georgia

Ltd Multiprofile Clinic "Consilium Medulla"; 🇬🇪 Tbilisi, Georgia

Instytut Zdrowia Dr Boczarska-Jedynak; 🇵🇱 Oswiecim, Malopolskie, Poland

MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak; 🇵🇱 Wroclaw, Poland

MUDr. Beata Dupejova, Neurologicka ambulancia, s.r.o.; 🇸🇰 Banska Bystrica, Slovakia

Rigshospitalet Glostrup-Nordre Ringvej 57; 🇩🇰 Glostrup, Capital, Denmark