Study on Lu AG09222 for Preventing Migraines in Adults Unresponsive to Previous Treatments

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What is this study about?

This clinical trial is focused on studying the prevention of migraine, a common type of headache that can cause severe pain, nausea, and sensitivity to light and sound. The study will test a new treatment called Lu AG09222, which is given as a solution for injection. Participants in the trial will receive either the new treatment or a placebo, which is a substance with no active medication, to compare the effects.

The purpose of the study is to evaluate how effective Lu AG09222 is in preventing migraines in adults who have not found relief from previous preventive treatments. The study will involve participants with both episodic and chronic forms of migraine. During the trial, participants will be randomly assigned to different groups, and neither the participants nor the researchers will know who is receiving the actual treatment or the placebo. This approach helps ensure that the results are unbiased.

Participants will be monitored over a period of time to track changes in their migraine frequency and severity. The study will also assess the safety of Lu AG09222 by checking for any side effects and changes in health indicators such as vital signs and laboratory test results. The trial aims to provide valuable information on whether this new treatment can offer a new option for people suffering from migraines.

1 joining the study

Upon joining the study, the participant is confirmed to have a diagnosis of migraine as defined by specific guidelines. This includes either migraine without aura, migraine with typical aura, or chronic migraine.

The participant must have experienced migraines for at least 12 months before joining the study and must be between 18 and 65 years old.

2 screening period

During the first 28 days, the participant uses an electronic diary (eDiary) to record migraine occurrences. This helps confirm the frequency of migraines and headaches.

For episodic migraine, migraines should occur on at least 4 days, and headaches on less than 15 days. For chronic migraine, migraines should occur on at least 8 days, and headaches on 15 to 26 days.

3 treatment phase

The participant receives either the investigational medication Lu AG09222 or a placebo. The medication is administered as a solution for injection under the skin (subcutaneous).

The trial is designed to find the appropriate dose for preventing migraines in those who have not been helped by previous treatments.

4 monitoring and evaluation

The participant continues to use the eDiary to track migraines and headaches over a 12-week period.

The primary goal is to observe changes in the frequency of migraines from the start of the study. Secondary goals include assessing the response to the medication and monitoring any side effects.

5 completion of the study

The study is expected to conclude by June 30, 2026. The participant’s data will contribute to understanding the effectiveness and safety of Lu AG09222 for migraine prevention.

Who Can Join the Study?

  • The participant must have a diagnosis of migraine as defined by specific guidelines, confirmed at the Screening Visit.
  • The participant must have had migraines starting at least 12 months before the Screening Visit.
  • The participant must have started having migraines at or before the age of 50.
  • The participant must have experienced at least 4 migraine days per month for each of the past 3 months before the Screening Visit.
  • The participant must meet specific criteria for EM (Episodic Migraine) or CM (Chronic Migraine) based on information collected in an electronic diary during the first 28 days of the Screening Period:
    • For EM: migraines on at least 4 days and headaches on less than 15 days.
    • For CM: migraines on at least 8 days and headaches on 15 to 26 days.
  • The participant must have used the electronic diary to enter data for at least 24 out of the 28 days following the Screening Visit.
  • The participant must have had treatment failure in the past 10 years with at least 2 to 4 different migraine preventive medications, with at least one failure due to inadequate effectiveness. These medications include:
    • Propranolol or Metoprolol
    • Topiramate
    • Amitriptyline
    • Flunarizine or Lomerizine
    • Candesartan
    • Valproate or Divalproex
    • Botulinum toxin (if used for Chronic Migraine)
  • The participant must be between 18 and 65 years old at the Screening Visit.

Who Cannot Join the Study?

  • Patients who have a different type of headache that is not a migraine cannot participate. A migraine is a type of headache that often comes with nausea and sensitivity to light and sound.
  • Patients who are not within the specified age range for the study cannot participate. The age range is determined by the study organizers.
  • Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.
  • Patients who have any other medical conditions that might interfere with the study cannot participate. This is to ensure the safety and accuracy of the study results.
  • Patients who are currently taking medications that might affect the study cannot participate. This is to prevent any interference with the study’s findings.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
ClinHouse Centrum Medyczne Zabrze Poland
Hospital Universitario Y Politecnico La Fe Valencia Spain
University Hospital Of Clermont-Ferrand Clermont Ferrand France
Hospital Universitario Hm Sanchinarro Madrid Spain
University Medicine Greifswald Greifswald Germany
Centre Hospitalier Universitaire De Lille Lille France
Oncopole Claudius Regaud Toulouse France
Hospital Universitario De Navarra Pamplona Spain
Specjalistyczne Gabinety Lekarskie Landa Cracow Poland

Other Sites

Site Name City Country Status
Diagnostics And Consultation Center Convex Ltd. Sofia Bulgaria
Praglandia s.r.o. Prague Czechia
Hospital Del Mar Barcelona Spain
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos Kaunas Lithuania
Mtz Clinical Research Powered By Pratia Warsaw Poland
Centrum Opieki Zdrowotnej Orkan-Med Stec – Michalska Sp. j. Ksawerow Poland
Rcmed Oddzial Sochaczew Sochaczew Poland
Centrum Medyczne Hcp Sp. z o.o. Poznan Poland
Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o.o. Nowa Sol Poland
INEP medical s.r.o. Prague Czechia
Schmerzklinik Kiel Gmbh & Co. KG Klinik fuer neurologisch-verhaltensmedizinische Schmerztherapie Kiel Germany
Appletreeclinics Network Sp. z o.o. Lodz Poland
Liptovska Nemocnica S Poliklinikou Mudr. Ivana Stodolu Liptovsky Mikulas Liptovsky Mikulas Slovakia
Clubul Sanatatii S.R.L. Campulung Romania
Policlinica CCBR S.R.L. Bucharest Romania
Siteworks GmbH Hanover Germany
University Multiprofile Hospital For Active Treatment Saint Georgi EAD Plovdiv Bulgaria
Clintrial s.r.o. Prague Czechia
curiositas ad sanum Studien und Beratungs GmbH Haag in Obb Germany
Diagnostic Consultative Center 14 Sofia EOOD Sofia Bulgaria
Neurosanatio s.r.o. Litomysl Czechia
Neuros s.r.o. Plzen Czechia
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Vilniaus universiteto ligonine Santaros klinikos VšĮ Vilnius Lithuania
Spitalul Clinic Judetean De Urgenta Sfantul Apostol Andrei Constanta Constanta Romania
Pratia S.A. Skorzewo Poland
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Universitaire De Nice Nice France
Rigshospitalet Copenhagen Denmark
Klaipedos universiteto ligonine VšĮ Klaipeda Lithuania
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Roskilde University Roskilde Denmark
Medical Center Teodora EOOD Ruse Bulgaria
Indywidualna Praktyka Lekarska dr hab. med. Anna Szczepanska-Szerej Lublin Poland
Neuroprotect Sp. z o.o. Warsaw Poland
University First multiprofile hospital for active treatment Sofia St. Joan Krastitel EAD Sofia Bulgaria
Forbeli s.r.o. Prague Czechia
Centrum Leczenia MIGRE Wroclaw Poland
Clinirem Sp. z o.o. Lublin Poland
Centrum Medyczne HOPE Clinic Sebastian Szklener Lublin Poland
Neurologie Rs Centrum s.r.o. Hradec Kralove Czechia
MP-neuro s.r.o. Slezska Ostrava Czechia
Centrum Kliniczno-Badawcze J.Brzezicki B.Gornikiewicz-Brzezicka Lekarze sp.p. Elblag Poland
Aovz Cyavjiua swyjax Prague Czechia
Ik Mjdgj sdtxfh Bardejov Slovakia
Mnsvzjb Cunmfd Ngydrvvkaeew Eeit Plovdiv Bulgaria
Msfxgfk Cjsupjn Udd Taurage Lithuania
Nqfkhiek Zfwz sotyjy Zlin Czechia
Doit Mynwxav sbgsbl Prague Czechia
Fnlsz Cqifnr Slhipr Bucharest Romania
Mawco Bmbyv Dkiffuas nknybrashbmy aakslxpycf szqftx Banska Bystrica Slovakia
Snetus sgwivf Presov Slovakia
Nitzmjsgry Scl z ocwg sqgol Katowice Poland
Uhejlrzhgvh njqojozgk &stwgxn Npusiuvgl sssebms Mzlcgjgv ai s Bratislava Slovakia
Aknnagkcue Pslzpqcs Huolxsvg Dt Mquezmkdn Marseille France
Biixczgf Ufuxkvcixf Hxvlfmcu Cnepgd Besançon France
Hmugaymt Vpwq dplqywzu Barcelona Spain
Spoyluruq Kfbl Budapest Hungary
Isryvxhg Zmpkjwd Dy Baaaficbpuzgswvck Oświęcim Poland
Skuslyvlxxjttd Dgu Bgxgfok Gyui Böblingen Germany
Knllvnbam suveqp Dubnica nad Váhom Slovakia

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Bulgaria Bulgaria
Not recruiting
14.08.2024
Czechia Czechia
Not recruiting
14.08.2024
Denmark Denmark
Not recruiting
14.08.2024
France France
Not recruiting
14.08.2024
Germany Germany
Not recruiting
14.08.2024
Hungary Hungary
Not recruiting
14.08.2024
Lithuania Lithuania
Not recruiting
14.08.2024
Poland Poland
Not recruiting
14.08.2024
Romania Romania
Not recruiting
14.08.2024
Slovakia Slovakia
Not recruiting
14.08.2024
Spain Spain
Not recruiting
14.08.2024

Trial locations

Investigated drugs:

Lu AG09222 is a medication being studied for its potential to prevent migraines. It is being tested in a clinical trial to see how well it works for people who experience both episodic and chronic migraines. The trial aims to find the right dose that can effectively reduce the frequency and severity of migraine attacks.

Investigated diseases:

Migraine – A migraine is a type of headache characterized by intense, throbbing pain, usually on one side of the head. It often comes with other symptoms like nausea, vomiting, and sensitivity to light and sound. Migraines can last for hours or even days and may be preceded by warning symptoms known as an aura, which can include visual disturbances or tingling sensations. The frequency and severity of migraines can vary widely among individuals. Some people experience migraines occasionally, while others may have them frequently, impacting daily activities. The exact cause of migraines is not fully understood, but they are believed to involve changes in brain chemicals and nerve pathways.

Trial ID:
2023-508821-28-00
Protocol code:
20297A
NCT ID:
NCT06323928
Trial Phase:
Therapeutic exploratory (Phase II)

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