Trial Outcomes & Findings for A Study With Lu AG09222 in Adults With Migraine Who Have Not Been Helped by Prior Preventive Treatments (NCT NCT05133323)

Last Updated: 2024-03-13

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

237 participants

Primary outcome timeframe

Baseline, Week 4

Results posted on

2024-03-13

Participant Flow

Participant milestones

Participant milestones
Measure	Lu AG09222 High Dose Participants received a single dose of Lu AG09222 by intravenous (IV) infusion.	Lu AG09222 Low Dose Participants received a single dose of Lu AG09222 by IV infusion.	Placebo Participants received a single dose of placebo matching to Lu AG09222 by IV infusion.
Overall Study STARTED	97	46	94
Overall Study Received at Least 1 Dose of Study Drug	97	46	94
Overall Study COMPLETED	95	45	93
Overall Study NOT COMPLETED	2	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Lu AG09222 High Dose Participants received a single dose of Lu AG09222 by intravenous (IV) infusion.	Lu AG09222 Low Dose Participants received a single dose of Lu AG09222 by IV infusion.	Placebo Participants received a single dose of placebo matching to Lu AG09222 by IV infusion.
Overall Study Lack of Efficacy	0	0	1
Overall Study Withdrawal by Subject	2	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lu AG09222 High Dose n=97 Participants Participants received a single dose of Lu AG09222 by intravenous (IV) infusion.	Lu AG09222 Low Dose n=46 Participants Participants received a single dose of Lu AG09222 by IV infusion.	Placebo n=94 Participants Participants received a single dose of placebo matching to Lu AG09222 by IV infusion.	Total n=237 Participants Total of all reporting groups
Age, Continuous	42.5 years STANDARD_DEVIATION 9.88 • n=5 Participants	42.5 years STANDARD_DEVIATION 9.35 • n=7 Participants	42.5 years STANDARD_DEVIATION 9.51 • n=5 Participants	42.5 years STANDARD_DEVIATION 9.59 • n=4 Participants
Sex: Female, Male Female	89 Participants n=5 Participants	38 Participants n=7 Participants	81 Participants n=5 Participants	208 Participants n=4 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	8 Participants n=7 Participants	13 Participants n=5 Participants	29 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	97 Participants n=5 Participants	46 Participants n=7 Participants	94 Participants n=5 Participants	237 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline, Week 4

Population: The APTS represents all randomized participants who received an infusion of investigational medicinal product

Outcome measures

Outcome measures
Measure	Lu AG09222 High Dose n=97 Participants Participants received a single dose of Lu AG09222 by intravenous (IV) infusion.	Lu AG09222 Low Dose n=46 Participants Participants received a single dose of Lu AG09222 by IV infusion.	Placebo n=94 Participants Participants received a single dose of placebo matching to Lu AG09222 by IV infusion.
Change From Baseline in the Number of Monthly Migraine Days (MMDs)	-6.2 days Standard Error 0.66	-6.0 days Standard Error 0.94	-4.2 days Standard Error 0.67

SECONDARY outcome

Timeframe: Baseline, Week 4

Population: The APTS represents all randomized participants who received an infusion of investigational medicinal product

Outcome measures

Outcome measures
Measure	Lu AG09222 High Dose n=97 Participants Participants received a single dose of Lu AG09222 by intravenous (IV) infusion.	Lu AG09222 Low Dose n=46 Participants Participants received a single dose of Lu AG09222 by IV infusion.	Placebo n=94 Participants Participants received a single dose of placebo matching to Lu AG09222 by IV infusion.
Percentage of Participants With ≥50% Reduction From Baseline in MMDs	32.2 percentage of participants	36.1 percentage of participants	26.8 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 4

Population: 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.

A Headache Day was defined as a day with a headache that lasted ≥30 minutes or that meets the definition of a Migraine Day.

Outcome measures

Outcome measures
Measure	Lu AG09222 High Dose n=96 Participants Participants received a single dose of Lu AG09222 by intravenous (IV) infusion.	Lu AG09222 Low Dose n=44 Participants Participants received a single dose of Lu AG09222 by IV infusion.	Placebo n=93 Participants Participants received a single dose of placebo matching to Lu AG09222 by IV infusion.
Change From Baseline in the Number of Monthly Headache Days (MHDs)	-5.8 days Standard Error 0.65	-5.9 days Standard Error 0.93	-4.1 days Standard Error 0.67

Adverse Events

Lu AG09222 High Dose

Serious events: 1 serious events

Other events: 18 other events

Deaths: 0 deaths

Lu AG09222 Low Dose

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Lu AG09222 High Dose n=97 participants at risk Participants received a single dose of Lu AG09222 by intravenous (IV) infusion.	Lu AG09222 Low Dose n=46 participants at risk Participants received a single dose of Lu AG09222 by IV infusion.	Placebo n=94 participants at risk Participants received a single dose of placebo matching to Lu AG09222 by IV infusion.
Musculoskeletal and connective tissue disorders Sympathetic Posterior Cervical Syndrome	1.0% 1/97 • Number of events 1 • Up to 12 weeks The APTS represents all randomized participants who received an infusion of investigational medicinal product	0.00% 0/46 • Up to 12 weeks The APTS represents all randomized participants who received an infusion of investigational medicinal product	0.00% 0/94 • Up to 12 weeks The APTS represents all randomized participants who received an infusion of investigational medicinal product

Other adverse events

Other adverse events
Measure	Lu AG09222 High Dose n=97 participants at risk Participants received a single dose of Lu AG09222 by intravenous (IV) infusion.	Lu AG09222 Low Dose n=46 participants at risk Participants received a single dose of Lu AG09222 by IV infusion.	Placebo n=94 participants at risk Participants received a single dose of placebo matching to Lu AG09222 by IV infusion.
Infections and infestations Covid-19	7.2% 7/97 • Number of events 7 • Up to 12 weeks The APTS represents all randomized participants who received an infusion of investigational medicinal product	4.3% 2/46 • Number of events 2 • Up to 12 weeks The APTS represents all randomized participants who received an infusion of investigational medicinal product	3.2% 3/94 • Number of events 3 • Up to 12 weeks The APTS represents all randomized participants who received an infusion of investigational medicinal product
Infections and infestations Nasopharyngitis	7.2% 7/97 • Number of events 7 • Up to 12 weeks The APTS represents all randomized participants who received an infusion of investigational medicinal product	0.00% 0/46 • Up to 12 weeks The APTS represents all randomized participants who received an infusion of investigational medicinal product	4.3% 4/94 • Number of events 5 • Up to 12 weeks The APTS represents all randomized participants who received an infusion of investigational medicinal product
General disorders Fatigue	5.2% 5/97 • Number of events 5 • Up to 12 weeks The APTS represents all randomized participants who received an infusion of investigational medicinal product	4.3% 2/46 • Number of events 2 • Up to 12 weeks The APTS represents all randomized participants who received an infusion of investigational medicinal product	1.1% 1/94 • Number of events 1 • Up to 12 weeks The APTS represents all randomized participants who received an infusion of investigational medicinal product

Additional Information

Email contact via

H. Lundbeck A/S

Phone: +4536301311

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place