Migraine
Conditions
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.
Interventions
DRUGLu AG09222
Lu AG09222 will be administered per schedule specified in the arm.
DRUGPlacebo
Placebo matching to Lu AG09222 will be administered per schedule specified in the arm.
Sponsors
H. Lundbeck A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
Countries
Czechia, Denmark, Georgia, Poland, Slovakia, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lu AG09222 High Dose Participants received a single dose of Lu AG09222 by intravenous (IV) infusion. | 97 |
| Lu AG09222 Low Dose Participants received a single dose of Lu AG09222 by IV infusion. | 46 |
| Placebo Participants received a single dose of placebo matching to Lu AG09222 by IV infusion. | 94 |
| Total | 237 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lack of Efficacy | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 1 | 0 |
Baseline characteristics
| Characteristic | Lu AG09222 High Dose | Lu AG09222 Low Dose | Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 42.5 years STANDARD_DEVIATION 9.88 | 42.5 years STANDARD_DEVIATION 9.35 | 42.5 years STANDARD_DEVIATION 9.51 | 42.5 years STANDARD_DEVIATION 9.59 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 97 Participants | 46 Participants | 94 Participants | 237 Participants |
| Sex: Female, Male Female | 89 Participants | 38 Participants | 81 Participants | 208 Participants |
| Sex: Female, Male Male | 8 Participants | 8 Participants | 13 Participants | 29 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 97 | 0 / 46 | 0 / 94 |
| other Total, other adverse events | 18 / 97 | 4 / 46 | 8 / 94 |
| serious Total, serious adverse events | 1 / 97 | 0 / 46 | 0 / 94 |
Outcome results
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
Time frame: Baseline, Week 4
Population: The APTS represents all randomized participants who received an infusion of investigational medicinal product
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Lu AG09222 High Dose | Change From Baseline in the Number of Monthly Migraine Days (MMDs) | -6.2 days | Standard Error 0.66 |
| Lu AG09222 Low Dose | Change From Baseline in the Number of Monthly Migraine Days (MMDs) | -6.0 days | Standard Error 0.94 |
| Placebo | Change From Baseline in the Number of Monthly Migraine Days (MMDs) | -4.2 days | Standard Error 0.67 |
p-value: 0.0106ANCOVA
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.
Time frame: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Lu AG09222 High Dose | Change From Baseline in the Number of Monthly Headache Days (MHDs) | -5.8 days | Standard Error 0.65 |
| Lu AG09222 Low Dose | Change From Baseline in the Number of Monthly Headache Days (MHDs) | -5.9 days | Standard Error 0.93 |
| Placebo | Change From Baseline in the Number of Monthly Headache Days (MHDs) | -4.1 days | Standard Error 0.67 |
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
Time frame: Baseline, Week 4
Population: The APTS represents all randomized participants who received an infusion of investigational medicinal product
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lu AG09222 High Dose | Percentage of Participants With ≥50% Reduction From Baseline in MMDs | 32.2 percentage of participants |
| Lu AG09222 Low Dose | Percentage of Participants With ≥50% Reduction From Baseline in MMDs | 36.1 percentage of participants |
| Placebo | Percentage of Participants With ≥50% Reduction From Baseline in MMDs | 26.8 percentage of participants |