Study of incobotulinumtoxinA injections for prevention of chronic migraine in adult patients

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What is this study about?

This clinical trial investigates the use of Xeomin (a type of botulinum toxin A) for people with chronic migraine. Chronic migraine is a condition where a person experiences headaches on 15 or more days per month, with at least 8 of these being migraine headaches, for more than 3 months. The study aims to determine if Xeomin injections are effective in reducing the number of days patients experience migraines compared to placebo.

The study medication will be given through intramuscular injections, meaning the medicine is injected directly into muscles. Participants will receive either Xeomin or placebo injections over a period of 6 months. The treatment involves multiple injection sessions, with the medication being administered at specific intervals throughout the study period.

During the trial, participants will need to keep track of their headaches and migraine days using a headache diary. The study will monitor how the treatment affects the frequency of migraine days, headache days, and the use of other migraine medications. The researchers will also track any side effects that may occur during the treatment period. The total study duration for each participant will be approximately 36 weeks.

1 Initial assessment

The study focuses on evaluating Xeomin® injections for preventing chronic migraine

Your eligibility will be confirmed based on your migraine history over the past 3 months

You must have experienced at least 15 headache days per month and at least 8 migraine days per month

2 Baseline period

For 28 days before starting treatment, you will need to keep a headache diary

The diary will help track your headache and migraine days

You must record at least 15 headache days and 8 migraine days during this period to continue in the study

3 Treatment phase

You will receive either Xeomin® (at one of two doses) or a placebo through muscle injections

The treatment will be given in cycles over 24 weeks (6 months)

Neither you nor your doctor will know which treatment you are receiving

4 Monitoring period

You will continue keeping a headache diary throughout the study

The main assessment will occur at Month 6 (weeks 21-24 after first injection)

Your migraine days, headache days, and use of acute migraine medications will be tracked

Any side effects related to the treatment will be monitored

5 Final evaluation

The study will evaluate changes in your monthly migraine days compared to the baseline period

The effectiveness of the treatment will be measured by a reduction in migraine frequency

Success will be determined if you experience at least a 50% reduction in monthly migraine days

Who Can Join the Study?

  • Must be at least 18 years old when signing the consent form
  • Must have been diagnosed with chronic migraine (with or without aura) for at least 12 months and be able to tell the difference between migraine headaches and other types of headaches
  • Must have first experienced migraines before the age of 50 years old
  • Must have experienced in each of the last 3 months:
    • At least 15 headache days per month
    • At least 8 migraine days per month
  • During the last 28 days of the screening period, must have:
    • At least 15 headache days
    • At least 8 migraine days recorded in the headache diary

Who Cannot Join the Study?

  • Age below 18 or above 65 years
  • Pregnant or breastfeeding women
  • History of botulinum toxin (a protein that can temporarily reduce muscle activity) treatment in the past 6 months
  • Known allergies or hypersensitivity to botulinum toxin or any components of the study medication
  • Current use of medications that could interact with botulinum toxin
  • Presence of any neuromuscular junction disorders (conditions affecting nerve and muscle connections)
  • Active infection at potential injection sites
  • History of facial surgery that could affect the study results
  • Participation in another clinical trial within the past 30 days
  • Any medical condition that could interfere with the evaluation of the study medication
  • Unable to follow study procedures or attend scheduled visits
  • History of drug or alcohol abuse within the past year
  • Mental conditions that could affect the ability to provide informed consent

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Medizinische Universitaet Innsbruck Innsbruck Austria
Azienda Ospedaliero Universitaria Careggi Florence Italy
Hospital Universitario Y Politecnico La Fe Valencia Spain
University Hospital Of Clermont-Ferrand Clermont Ferrand France
University Medicine Greifswald Greifswald Germany
Futuremeds Sp. z o.o. Wroclaw Poland
CHU Grenoble Alpes La Tronche France
Medical University Of Vienna Vienna Austria

Other Sites

Site Name City Country Status
Etg Neuroscience Sp. z o.o. Warsaw Poland
Fondazione Istituto Neurologico Nazionale Casimiro Mondino Pavia Italy
Hospital Universitario 12 De Octubre Madrid Spain
Silmedic Sp. z o.o. Katowice Poland
Solumed Sp. z o.o. sp.k. Poznan Poland
Centrum Medyczne Neuromed Sp. z o.o. Bydgoszcz Poland
Athleticomed Sp. z o.o. Bydgoszcz Poland
Schmerzklinik Kiel Gmbh & Co. KG Klinik fuer neurologisch-verhaltensmedizinische Schmerztherapie Kiel Germany
Vitos Orthopaedische Klinik Kassel gGmbH Kassel Germany
Liptovska Nemocnica S Poliklinikou Mudr. Ivana Stodolu Liptovsky Mikulas Liptovsky Mikulas Slovakia
Krakowska Akademia Neurologii Sp. z o.o. Cracow Poland
Consorci Sanitari De Terrassa Terrassa Spain
Landeskrankenanstalten-Betriebsgesellschaft Kabeg Klagenfurt am Wörthersee Austria
Virgen del Rocío University Hospital Sevilla Spain
Odense University Hospital Odense Denmark
Ospedale San Raffaele S.r.l. Milan Italy
Hospital Clinic De Barcelona Barcelona Spain
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Irccs San Raffaele Roma S.r.l. Rome Italy
Pratia S.A. Skorzewo Poland
Centre Hospitalier Universitaire De Nantes Nantes France
Hospital Vithas Parque San Antonio Malaga Spain
Rigshospitalet Copenhagen Denmark
Hospital Alvaro Cunqueiro Vigo Spain
Pratia Brno s.r.o. Brno-Stred Czechia
Neuropsychiatrie s.r.o. Prague Czechia
Clintrial s.r.o. Prague Czechia
Hospital Universitario Virgen De La Victoria Malaga Spain
Centrum Leczenia MIGRE Wroclaw Poland
Clinirem Sp. z o.o. Lublin Poland
Studienzentrum Nord-West Westerstede Germany
Kopfschmerzzentrum Frankfurt Frankfurt Germany
Indywidualna Praktyka Lekarska dr hab. med. Anna Szczepanska-Szerej Lublin Poland
Nwileegg Bmwvlocryjlcj Tkktmcjlxny Lvjcygg sxnog Cracow Poland
Ngscpz srvpvi Krompachy Slovakia
Mhtjn Bwmwb Domhkiyx nqfuchpastqb anfihmrtlw scvrpv Banska Bystrica Slovakia
Jmz Bawsgb Rnjevtac Shtz Cracow Poland
Ewj Zvfnlw Zamosc Poland
Epq Lpsjke Lublin Poland
Fymzmvrkf Pnrn Lt Ikbmdqcinexhp Bhrhqlsun Dhn Hassndfj Uenhmppxbycup Le Pzp Madrid Spain
Nkhjiscn Zrat sbeanl Zlin Czechia
Ahel Cubnyuys syphbh Prague Czechia
Hwtowjph Vquz dskltogc Barcelona Spain
Ivzyhwmu Zpjwmjw Do Bvghtiylomjhfspqp Oświęcim Poland
Kxsieaelf sjunln Dubnica nad Váhom Slovakia
Iluup Ollwnfii Aanjfthfmn Sgb Lbky Milan Italy
Finbozkax Nvadvgwipe Zaragoza Spain

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

Trial status

Country Status Recruitment Start
Austria Austria
Recruiting
01.10.2025
Czechia Czechia
Recruiting
01.10.2025
Denmark Denmark
Recruiting
01.10.2025
France France
Recruiting
01.10.2025
Germany Germany
Recruiting
01.10.2025
Italy Italy
Recruiting
01.10.2025
Poland Poland
Recruiting
01.10.2025
Slovakia Slovakia
Recruiting
01.10.2025
Spain Spain
Recruiting
01.10.2025

Trial locations

Xeomin is a type of botulinum toxin medication that is injected into specific areas. It works by temporarily blocking nerve signals that cause muscle contractions. In this trial, it is being studied for preventing chronic migraine headaches. The medication is injected into various points around the head and neck area to help reduce the frequency and severity of migraine headaches. This treatment is typically administered by a healthcare professional in a medical setting.

Chronic Migraine – A neurological condition characterized by headaches occurring on 15 or more days per month for more than three months, with at least eight of these headaches being migraines. The pain typically affects one or both sides of the head and is often accompanied by nausea, sensitivity to light and sound, and visual disturbances. Episodes can last from several hours to days, significantly impacting daily activities. The condition tends to develop gradually, often evolving from episodic migraines. Patients may experience varying intensity of symptoms, with some days having more severe headaches than others.

Trial ID:
2024-515682-34-00
Protocol code:
M602011084
Trial Phase:
Therapeutic confirmatory (Phase III)

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