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

Migraine Clinical Trial

Official title:

Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of Lu AG09222 for the Prevention of Migraine in Patients With Unsuccessful Prior Preventive Treatments

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05133323
• Other study ID #: 19678A
• Status: Completed
• Phase: Phase 2
• Start date: November 11, 2021
• Est. completion date: March 16, 2023

Study information

• Verified date: March 2024
• Source: H. Lundbeck A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 237
• Est. completion date: March 16, 2023
• Est. primary completion date: January 19, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

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

Locations

Country	Name	City	State
Czechia	Fakultni nemocnice u sv. Anny v Brne	Brno	Jihomoravsky Kraj
Czechia	NEUROHK, s.r.o.	Chocen
Czechia	CCR Ostrava s.r.o.	Ostrava	Moravskoslezsky Kraj
Czechia	Mestska nemocnice Ostrava, p.o.	Ostrava	Moravskoslezsky Kraj
Czechia	CCR Czech	Pardubice	Pardubicky Kraj
Czechia	CLINTRIAL s.r.o.	Prague
Czechia	CCR Prague s.r.o.	Praha	Praha, Hlavní Mesto
Czechia	FORBELI s.r.o.	Praha 6
Czechia	INEP Medical s.r.o.	Praha 8
Denmark	Aarhus Universitetshospital	Aarhus N	Central Jutland
Denmark	Rigshospitalet Glostrup-Nordre Ringvej 57	Glostrup	Capital
Georgia	Archangel St Michael Multiprofile Clinical Hospital Ltd	Tbilisi
Georgia	Aversi Clinic LTD	Tbilisi
Georgia	Ltd Israel-Georgia Medical Research Clinic Helsicore	Tbilisi
Georgia	LTD MediClubGeorgia	Tbilisi
Georgia	Ltd Multiprofile Clinic "Consilium Medulla"	Tbilisi
Georgia	Malkhaz Katsiashvili Multiprofile Emergency Medicine Center	Tbilisi
Poland	Centrum Medyczne Silmedic Sp z o o	Katowice	Slaskie
Poland	Pratia MCM	Krakow	Malopolskie
Poland	Instytut Zdrowia Dr Boczarska-Jedynak	Oswiecim	Malopolskie
Poland	Solumed SC	Poznan	Wielkopolskie
Poland	ETG Singua - PPDS	Warszawa	Mazowieckie
Poland	MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak	Wroclaw
Slovakia	MUDr. Beata Dupejova, Neurologicka ambulancia, s.r.o.	Banska Bystrica
Slovakia	KONZILIUM s.r.o	Dubnica nad Vahom
United States	Allied Biomedical Research Institute	Miami	Florida
United States	Excell Research - ClinEdge - PPDS	Oceanside	California
United States	UNISON Clinical Trials (Shahram Jacobs md inc.)	Sherman Oaks	California

Sponsors (1)

Lead Sponsor	Collaborator
H. Lundbeck A/S

Countries where clinical trial is conducted

United States,  Czechia,  Denmark,  Georgia,  Poland,  Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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: 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	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: 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	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