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MigrainePhase 2PROCEEDNCT06323928

A Dose-finding Trial 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 120 sites in 14 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this trial is to determine which doses of Lu AG09222 are recommended to help prevent migraines. People who join this trial have already tried 1 to 4 other available medications to prevent their migraines, but these medications have not helped them. 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
874 participants
Where
120 sitesin 14 countries
Study dates
1 Apr 2024to 16 Mar 2026
Phase
Phase 2
Are there results?
None posted in the registry

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 ≥ 12 months prior to the Screening Visit.
  • The participant has a migraine onset at ≤50 years of age.
  • The participant has ≥4 migraine days per month for each month within the past 3 months prior to the Screening Visit.
  • The participant has documented evidence of treatment failure in the past 10 years of at least 1 to 4 (maximum) different migraine preventive medications.

Who cannot join

  • The participant has previously been dosed with an anti-pituitary adenylate cyclase-activating peptide (anti-PACAP treatment).
  • 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.
  • Additional protocol-defined criteria apply.

Trial locations and contacts

120 sites in 14 countries.

120 sites in 14 countries

United States28 sites

  • Accellacare and McFarland Clinic

    Ames, Iowa, 50010

  • Dent Neurosciences Research Center, Inc.

    Amherst, New York, 14226

  • Internal Medicine and Pediatric Associates of Bristol, PC

    Bristol, Tennessee, 37620

  • Profound Research - Neurology Center of Southern California

    Carlsbad, California, 92011

  • Accellacare of Cary - Cary Medical Group

    Cary, North Carolina, 27518

  • Clinical Research Professionals

    Chesterfield, Missouri, 63005

  • K2 Medical Research - Winter Garden

    Clermont, Florida, 34711

  • Cedar Health Research, LLC

    Dallas, Texas, 75251

  • Neurology Center of North Orange County

    Fullerton, California, 92835

  • Headache Wellness Center

    Greensboro, North Carolina, 27405

  • Healthcare Research Network

    Hazelwood, Missouri, 63042

  • Accel Research Sites Network - Neurology and Neurodiagnostic of Alabama

    Hoover, Alabama, 35244-5700

  • Clinical Neuroscience Solutions, Inc.

    Jacksonville, Florida, 32256

  • CenExel CNS

    Los Alamitos, California, 90720

  • K2 Medical Research, LLC - Maitland

    Maitland, Florida, 32751

  • MedStar Health - Neurology Clinic at McLean

    McLean, Virginia, 22101

  • Accellacare of Charleston

    Mt. Pleasant, South Carolina, 29464

  • Aqualane Clinical Research

    Naples, Florida, 34105

  • North Suffolk Neurology, PC.

    Port Jefferson Station, New York, 11776

  • Raleigh Medical Group

    Raleigh, North Carolina, 27609

  • M3 Wake Research, Inc

    Raleigh, North Carolina, 27612

  • Accellacare of Rocky Mount

    Rocky Mount, North Carolina, 27804

  • ASCLEPES Research Centers

    Sherman Oaks, California, 91403

  • Ki Health Partners LLC DBA New England Institute for Clinical Research

    Stamford, Connecticut, 06905

  • Mercury Clinical Research

    Sugar Land, Texas, 77478

  • K2 Medical Research Tampa LLC

    Tampa, Florida, 33607

  • Premiere Research Institute Palm Beach

    West Palm Beach, Florida, 33407

  • Triad Neurological Associates

    Winston-Salem, North Carolina, 27103

Other trials in United States

Poland19 sites

  • Centrum Medczyne Pratia Bydgoszcz

    Bydgoszcz, 85-796

  • Centrum Kliniczno-Badawcze J.Brzezicki, B.Gornikiewicz-Brzezicka Lekarze Spolka partnerska

    Elblag, 82-300

  • Neuro-Care sp. z o.o. sp. Komandytowa

    Katowice, Silesian Voivodeship, 40-749

  • Landa Specjalistyczne Gabinety Lekarskie

    Krakow, Lesser Poland Voivodeship, 31-156

  • Pratia MCM Krakow

    Krakow, 30-727

  • Centrum Opieki Zdrowotnej OrkanMed

    Ksawerów, 95-054

  • Appletreeclinics Network Sp. z o.o.

    Lodz, 90-347

  • Clinirem Sp. z o.o.

    Lublin, 20-064

  • Indywidualna Praktyka Lekarska Dr hab. n. med. Anna Szczepanska-Szerej

    Lublin, 20-582

  • Centrum Medyczne Hope Clinic Sebastian Szklener

    Lublin, 20-701

  • Twoja Przychodnia NCM

    Nowa Sól, 67-100

  • Instytut Zdrowia dr Boczarska-Jedynak

    Oświęcim, 32-600

  • Neurologiczny Niepubliczny ZOZ Centrum Leczenia SM Osrodek Badan Klinicznych im. dr n. med. Hanki...

    Plewiska, 62-064

  • Centrum Medyczne HCP sp. z o.o

    Poznan, Greater Poland Voivodeship, 61-485

  • RCMed Oddzial Sochaczew

    Sochaczew, 96-500

  • Centrum Medyczne Neuroprotect

    Warsaw, Masovian Voivodeship, 01-684

  • MTZ Clinical Research Powered by Pratia

    Warsaw, 02-172

  • MIGRE Polskie Centrum Leczenia Migreny

    Wroclaw, 52-210

  • ClinHouse Centrum Medyczne

    Zabrze, 41-807

Other trials in Poland

Japan16 sites

  • Shonan Keiiku Hospital

    Fujisawa-shi, Kanagawa, 252-0816

  • Saitama Medical University Hospital

    Iruma-gun, Saitama, 350-0495

  • Tanaka Neurosurgery & Headache Clinic

    Kagoshima, Kagoshima-ken, 890-0052

  • Atsuchi Neurosurgical Hospital

    Kagoshima, Kagoshima-ken, 892-0842

  • Jinnouchi Neurosurgery Clinic

    Kasuga-shi, Fukuoka, 816-0802

  • Ikeda Neurosurgery Clinic

    Kasuga-shi, Fukuoka, 816-0824

  • Shinagawa Strings Clinic

    Minato-ku, Tokyo, 108-0075

  • Kitasato University Kitasato Institute Hospital

    Minato-ku, Tokyo, 108-8642

  • Mito Kyodo General Hospital

    Mito, Ibaraki, 310-0015

  • Iwate Medical University Uchimaru Medical Center

    Morioka, Iwate, 020-8505

  • Tominaga Hospital

    Osaka, Osaka, 556-0017

  • Nakamura Memorial Hospital

    Sapporo, Hokkaido, 060-0061

  • Sendai Headache and Neurology Clinic Medical Corporation

    Sendai, Miyagi, 982-0014

  • Dokkyo Medical University Hospital

    Shimotsuga-Gun, Tochigi, 321-0293

  • Japanese Red Cross Shizuoka Hospital

    Shizuoka, Shizuoka, 420-0853

  • Keio University Hospital

    Tokyo, 160-8582

Other trials in Japan

Czechia11 sites

  • Dr. Radomir Talab MD, Office of

    Hradec Králové, 500 03

  • Neurosanatio s.r.o.

    Litomyšl, Pardubice Region, 57001

  • Neuros s.r.o

    Pilsen, 30100

  • Clintrial s. r. o.

    Prague, 100 00

  • DADO MEDICAL s.r.o.

    Prague, 12000

  • Praglandia s.r.o

    Prague, 150 00

  • Axon Clinical s r.o

    Prague, 15500

  • Neurologicka ordinace FORBELI sro

    Prague, 160 00

  • Institut neuropsychiatricke pece

    Prague, 18600

  • Neurologicka ambulance

    Slezská Ostrava, 710 00

  • NeuroMed Zlin s.r.o.

    Zlín, 76001

Other trials in Czechia

Georgia8 sites

  • Malkhaz Katsiashvili Multiprofile Emergency Medicine Center

    Tbilisi, 0101

  • Caucasus Medical Center Ltd

    Tbilisi, 0102

  • Archangel St Michael Multiprofile Clinical Hospital

    Tbilisi, 0159

  • Jo Ann Medical Center

    Tbilisi, 0159

  • JSC K. Eristavi National Center of Experimental and Clinical Surgery

    Tbilisi, 0159

  • Aversi Clinic

    Tbilisi, 0160

  • MD Georgia Staff Physician MediClub Georgia

    Tbilisi, 0160

  • S. Khechinashvili University Hospital

    Tbilisi, 0179

Other trials in Georgia

Spain7 sites

  • Hospital General Universitario de Alicante

    Alicante, 03010

  • Parc de Salut Mar - Hospital del Mar

    Barcelona, 08003

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035

  • Clinica Universidad de Navarra

    Madrid, 28022

  • Clinica Universidad de Navarra

    Pamplona, 31008

  • Hospital Clinico Universitario de Valencia (Instituto de Investigacion Sanitaria INCLIVA)

    Valencia, 46010

  • Hospital Universitario La Fe de Valencia

    Valencia, 46026

Other trials in Spain

France6 sites

  • Centre Hospitalier Universitaire de Lyon, Hopital Pierre Wertheimer

    Bron, 69500

  • Centre Hospitalier Universitaire de Clermont Ferrand - Gabriel Montpied

    Clermont-Ferrand Cedex1, 63003

  • Centre Hospitalier Regional Universitaire de Lille - Hopital Roger Salengro

    Lille, 59037

  • Assistance Publique Hopitaux de Marseille (AP-HM) - Hopital de La Timone

    Marseille, 13385

  • Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Lariboisiere

    Paris, 75010

  • Centre Hospitalier Universitaire (CHU) de Toulouse - Hopital Pierre-Paul Riquet

    Toulouse, 31059

Other trials in France

Germany6 sites

  • Charite - Universitaetsmedizin Berlin - Campus Charite Mitte (CCM)

    Berlin, 10117

  • Studienzentrum Dr. Bischof GmbH

    Böblingen, 71034

  • Klinik Haag i. OB

    Ebersberg, 85560

  • Headache Center Frankfurt

    Frankfurt, 65929

  • Siteworks - Hannover

    Hanover, 30449

  • Siteworks - Heidelberg

    Heidelberg, 69115

Other trials in Germany

Bulgaria4 sites

  • MC Nevrocentrum

    Plovdiv, 4000

  • University Multiprofile Hospital for Active Treatment Sveti Georgi

    Plovdiv, 4002

  • MC Rusemed-OOD

    Rousse, 7000

  • Diagnostic Consultative Center Convex Ltd

    Sofia, Sofiiska, 1680

Other trials in Bulgaria

Lithuania4 sites

  • Hospital of Lithuanian University of Health Sciences Kaunas

    Kaunas, 50161

  • Klaipeda¿s University Hospital

    Klaipėda, LT-92288

  • Medicum Centrum

    Tauragė, 72250

  • Vilniaus Universiteto Medicinos Fakultetas - Neurologijos ir Neurochirurgijos Klinika - Neurologi...

    Vilnius, 08661

Other trials in Lithuania

Slovakia4 sites

  • Private Practice - Dr. Beáta Dupejová

    Banská Bystrica, 974 04

  • IN MEDIC s.r.o

    Bardejov, 085 01

  • KONZILIUM s.r.o.

    Dubnica nad Váhom, 018 41

  • SANERA, s.r.o.

    Prešov, 08001

Other trials in Slovakia

Romania3 sites

  • Policlinica CCBR S.R.L.

    Bucharest, 30463

  • Sc Clubul Sanatatii S.R.L.

    Campulung Muscel, Judet Arges, 115100

  • The Emergency County Clinical Hospital St. Andrew Constanta

    Constanța, 900591

Other trials in Romania

Denmark2 sites

  • Bispebjerg Hospital - Region Capital

    Copenhagen, 2400

  • Glostrup Hospital

    Glostrup Municipality, 2600

Other trials in Denmark

Hungary2 sites

  • S-Medicon Kft.

    Budapest, Central Hungary (Közép-Magyarország), 1044

  • Komarom-Esztergom Varmegyei Szent Borbala Korhaz

    Tatabánya, 2800

Other trials in Hungary

About this study

Official title: Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled, Dose-finding Trial of Lu AG09222 for the Prevention of Migraine in Participants With Unsuccessful Prior Preventive Treatments

The purpose of this trial is to determine which doses of Lu AG09222 are recommended to help prevent migraines. People who join this trial have already tried 1 to 4 other available medications to prevent their migraines, but these medications have not helped them.

Conditions
Migraine
Being tested
Lu AG09222, Placebo
Keywords
Headache, Chronic Migraine, Episodic Migraine
Medical subject headings
Migraine Disorders, Headache

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 the arm description.

  • PlaceboDrug

    Placebo matching to Lu AG09222 will be administered per the arm description

Study groups in NCT06323928
Study groupRoleWhat they receive
Group A: Placebo SC (closed for recruitment)Placebo comparatorParticipants will receive 2 injections of placebo.
Receives: Drug: Placebo
Group B: Lu AG09222 SC (closed for recruitment)ExperimentalParticipants will receive 1 injection of placebo and 1 injection containing Lu AG09222.
Receives: Drug: Lu AG09222; Drug: Placebo
Group C: Lu AG09222 SC (closed for recruitment)ExperimentalParticipants will receive 1 injection of placebo and 1 injection containing Lu AG09222.
Receives: Drug: Lu AG09222; Drug: Placebo
Group D: Lu AG09222 SC (closed for recruitment)ExperimentalParticipants will receive 1 injection of placebo and 1 injection containing Lu AG09222.
Receives: Drug: Lu AG09222; Drug: Placebo
Group E: Lu AG09222 SC (closed for recruitment)ExperimentalParticipants will receive 2 injections, each containing Lu AG09222.
Receives: Drug: Lu AG09222
Group F: Placebo IVPlacebo comparatorParticipants will receive placebo by intravenous (IV) infusion.
Receives: Drug: Placebo
Group G: Lu AG09222 IVExperimentalParticipants will receive Lu AG09222 by IV infusion.
Receives: Drug: Lu AG09222
Group H: Lu AG09222 IVExperimentalParticipants will receive Lu AG09222 by IV infusion.
Receives: Drug: Lu AG09222
Group I: Lu AG09222 IVExperimentalParticipants will receive Lu AG09222 by IV infusion.
Receives: Drug: Lu AG09222

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in the Number of Monthly Migraine Days (MMDs)

    Measured: Baseline up to Week 12 (Weeks 1-12)

Secondary outcomes (6)

  1. Change From Baseline in MMDs

    Measured: Baseline up to Week 12 (Weeks 1-12)

  2. Percentage of Participants With ≥50% Reduction From Baseline in MMDs

    Measured: Baseline up to Week 12 (Weeks 1-12)

  3. Percentage of Participants With ≥75% Reduction From Baseline in MMDs

    Measured: Baseline up to Week 12 (Weeks 1-12)

  4. Change from Baseline in the Number of Monthly Headache Days

    Measured: Baseline up to Week 12 (Weeks 1-12)

  5. Number of Participants with Treatment-emergent Adverse Events (TEAEs)

    Measured: Up to Week 20

  6. Number of Participants with Anti-drug Antibodies (ADA)

    Measured: Up to Week 20

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Mar 2024
  2. Study start1 Apr 2024
  3. Primary completion16 Jan 2026
  4. Study completion16 Mar 2026

Resources

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
874 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06323928
Sponsor's protocol ID
20297A
Other IDs
2023-508821-28-00, 2023
Acronym
PROCEED
Status last verified
Jun 2026
First submitted
15 Mar 2024
Last updated
12 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

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 120 sites in 14 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 5 inclusion and 5 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 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 120 sites in United States, Poland, Japan, Czechia, Georgia and 9 more countries. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 up to Week 12 (Weeks 1-12)). 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 NCT06323928.

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 12 Jun 2026.

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