MigrainePhase 2NCT05133323
A Study With Lu AG09222 in Adults With Migraine Who Have Not Been Helped by Prior Preventive Treatments
A Phase 2 study testing Lu AG09222 in people with Migraine, run by H. Lundbeck A/S at 28 sites in 6 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine
- What is being tested?
- Lu AG09222
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 237 participants
- Where
- 28 sitesin 6 countries
- Study dates
- 11 Nov 2021to 16 Mar 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
28 sites in 6 countries.
28 sites in 6 countries
Czechia9 sites
Fakultni nemocnice u sv. Anny v Brne
Brno, South Moravian, 656 91
NEUROHK, s.r.o.
Choceň, 565 01
CCR Ostrava s.r.o.
Ostrava, Moravian-Silesian Region, 702 00
Mestska nemocnice Ostrava, p.o.
Ostrava, Moravian-Silesian Region, 728 80
CCR Czech
Pardubice, Pardubice Region, 530 02
CCR Prague s.r.o.
Prague, Praha, Hlavní Mesto, 130 00
FORBELI s.r.o.
Prague, 160 00
INEP Medical s.r.o.
Prague, 186 00
CLINTRIAL s.r.o.
Prague
Georgia6 sites
Ltd Israel-Georgia Medical Research Clinic Helsicore
Tbilisi, 0112
Archangel St Michael Multiprofile Clinical Hospital Ltd
Tbilisi, 0159
Aversi Clinic LTD
Tbilisi, 0160
LTD MediClubGeorgia
Tbilisi, 0160
Malkhaz Katsiashvili Multiprofile Emergency Medicine Center
Tbilisi, 0172
Ltd Multiprofile Clinic "Consilium Medulla"
Tbilisi, 0186
Poland6 sites
Centrum Medyczne Silmedic Sp z o o
Katowice, Silesian Voivodeship, 40-282
Pratia MCM
Krakow, Lesser Poland Voivodeship, 30-510
Instytut Zdrowia Dr Boczarska-Jedynak
Oświęcim, Lesser Poland Voivodeship, 32-600
Solumed SC
Poznan, Greater Poland Voivodeship, 60-101
ETG Singua - PPDS
Warsaw, Masovian Voivodeship, 02-777
MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak
Wroclaw, 52-210
United States3 sites
Allied Biomedical Research Institute
Miami, Florida, 33155-4630
Excell Research - ClinEdge - PPDS
Oceanside, California, 92056-4515
UNISON Clinical Trials (Shahram Jacobs md inc.)
Sherman Oaks, California, 91403
Denmark2 sites
Aarhus Universitetshospital
Aarhus N, Central Jutland, 8200
Rigshospitalet Glostrup-Nordre Ringvej 57
Glostrup Municipality, Capital, 2600
Slovakia2 sites
MUDr. Beata Dupejova, Neurologicka ambulancia, s.r.o.
Banská Bystrica, 974 04
KONZILIUM s.r.o
Dubnica nad Váhom, 018 41
About this study
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
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.
Read the 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.
- Conditions
- Migraine
- Being tested
- Lu AG09222, Placebo
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lu AG09222Drug
Lu AG09222 will be administered per schedule specified in the arm.
PlaceboDrug
Placebo matching to Lu AG09222 will be administered per schedule specified in the arm.
| Study group | Role | What they receive |
|---|---|---|
| Lu AG09222 High Dose | Experimental | Participants will receive a single high dose of Lu AG09222 by intravenous (IV) infusion. Receives: Drug: Lu AG09222 |
| Lu AG09222 Low Dose | Experimental | Participants will receive a single low dose of Lu AG09222 by IV infusion. Receives: Drug: Lu AG09222 |
| Placebo | Placebo comparator | Participants will receive a single dose of placebo matching to Lu AG09222 by IV infusion. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, Week 4
Secondary outcomes (2)
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
Measured: Baseline, Week 4
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.
Measured: Baseline, Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study start11 Nov 2021
- Primary completion19 Jan 2023
- Study completion16 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by H. Lundbeck A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 237 participants (actual)
Sponsor and investigators
- Lead sponsor
- H. Lundbeck A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Email contact via H. Lundbeck A/S, Study director, H. Lundbeck A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05133323
- Sponsor's protocol ID
- 19678A
- Status last verified
- Mar 2024
- First submitted
- 15 Nov 2021
- Last updated
- 13 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 39231342
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05133323
- Acronym / sponsor ID
- 19678A
- Conditions
- Migraine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 237 participants (actual)
- Lead sponsor
- H. Lundbeck A/SIndustry (pharma, biotech, devices)
- Study start
- 11 Nov 2021 (actual)
- Primary completion
- 19 Jan 2023 (actual)
- Study completion
- 16 Mar 2023 (actual)
- First posted
- 24 Nov 2021 (actual)
- Results
- Posted 8 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lu AG09222 High Dose | Experimental | Drug: Lu AG09222Participants will receive a single high dose of Lu AG09222 by intravenous (IV) infusion. |
| Lu AG09222 Low Dose | Experimental | Drug: Lu AG09222Participants will receive a single low dose of Lu AG09222 by IV infusion. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive a single dose of placebo matching to Lu AG09222 by IV infusion. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lu AG09222Lu AG09222 will be administered per schedule specified in the arm. | Drug | Lu AG09222 High Dose, Lu AG09222 Low Dose |
| PlaceboPlacebo matching to Lu AG09222 will be administered per schedule specified in the arm. | Drug | Placebo |
Primary outcome
Change From Baseline in the Number of Monthly Migraine Days (MMDs)
Time frame: 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
2 secondary outcomes
Percentage of Participants With ≥50% Reduction From Baseline in MMDs
Time frame: Baseline, Week 4
Change From Baseline in the Number of Monthly Headache Days (MHDs)
Time frame: Baseline, Week 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39231342Ashina 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Email contact via H. Lundbeck A/S study director
H. Lundbeck A/S
28 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lu AG09222 in people with Migraine, run by H. Lundbeck A/S at 28 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in Czechia, Georgia, Poland, United States, Denmark and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in the Number of Monthly Migraine Days (MMDs) (time frame: Baseline, Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05133323, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2024.