Study of IncobotulinumtoxinA injections compared to placebo for prevention of episodic migraine attacks

3 1 1

What is this study about?

This clinical trial studies the effectiveness of Xeomin injections in preventing episodic migraine. Episodic migraine is a condition where a person experiences headaches with specific features, occurring between 6 to 14 days per month. The study uses Clostridium Botulinum neurotoxin type A, also known as incobotulinumtoxinA, which is administered through intramuscular injection.

The main purpose of this research is to determine if Xeomin is more effective than placebo in reducing the number of monthly migraine days. The study involves different doses of the medication, with participants receiving either Xeomin or placebo injections. The treatment period lasts for 6 months, during which participants will receive multiple injections.

The medication being tested, Xeomin, is a purified form of botulinum toxin that is free from complexing proteins. The study will monitor how the treatment affects the frequency of migraine days, headache days, and the use of acute migraine medications. Throughout the study, participants will need to keep track of their migraine episodes and any changes in their condition.

1 Initial assessment

The trial evaluates Xeomin® injections for preventing episodic migraine

You will need to confirm having 6-14 migraine days per month for the past 3 months

You will need to keep a headache diary for 28 days before starting treatment

2 Treatment assignment

You will be randomly assigned to receive either Xeomin® or a placebo (inactive substance)

Neither you nor your doctor will know which treatment you receive

The medication will be given through intramuscular injections (into the muscle)

3 Treatment period

The main study period lasts 6 months

You will receive multiple treatment cycles

You will need to continue keeping your headache diary throughout the study

Your migraine days will be monitored every two weeks during weeks 11-12 of each treatment cycle

4 Final evaluation

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

Changes in your monthly migraine days will be compared to your starting point

The number of days you needed migraine medication will be evaluated

Any side effects that occurred during treatment will be assessed

5 Extension period

After the main study period, there will be an extension period

The total study duration may continue until June 2028

Your participation will be monitored for safety throughout the entire study period

Who Can Join the Study?

Must be at least 18 years old when signing the consent form
Must have been diagnosed with episodic migraine (with or without aura) for 12 months or longer and be able to tell the difference between migraine headaches and other types of headaches
Must have had first migraine symptoms before age 50
In the 3 months before screening, must have:
- No more than 14 headache days per month
- Between 6 to 14 migraine days per month
During the last 28 days of screening period, must have:
- No more than 14 headache days
- Between 6 to 14 migraine days

Who Cannot Join the Study?

History of chronic migraine (15 or more headache days per month)
Current use of preventive migraine medications (drugs taken regularly to reduce frequency of migraines)
Previous treatment with botulinum toxin in the past 6 months
Presence of other types of headaches that could interfere with the assessment of migraines
Pregnancy or breastfeeding
Known allergic reactions to botulinum toxin products
Active neurological conditions (diseases affecting brain, nerves, or spinal cord)
History of neuromuscular junction disorders (conditions affecting nerve-muscle connections)
Use of medications that could interact with the study treatment
Participation in another clinical trial within the past 30 days
Presence of severe psychiatric disorders (mental health conditions requiring ongoing treatment)
Uncontrolled medical conditions that could affect study participation
History of substance abuse within the past year
Inability to follow study procedures or attend scheduled visits

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
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
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
Vitos Orthopaedische Klinik Kassel gGmbH	Kassel	Germany
Schmerzklinik Kiel Gmbh & Co. KG Klinik fuer neurologisch-verhaltensmedizinische Schmerztherapie	Kiel	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
Indywidualna Praktyka Lekarska dr hab. med. Anna Szczepanska-Szerej	Lublin	Poland
Pratia Brno s.r.o.	Brno-Stred	Czechia
Clintrial s.r.o.	Prague	Czechia
Neuropsychiatrie 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
Nxchmgqu Bvzxyijmssqzr Tczmoxfseid Lbpetgn srfwn	Cracow	Poland
Nhatso sldsit	Krompachy	Slovakia
Mfyzr Bived Dnklwkvc nuqddwrzhaxz applqxmnlp sdkruz	Banska Bystrica	Slovakia
Eld Zjxjgc	Zamosc	Poland
Eqy Lmoudu	Lublin	Poland
Fidbberrl Phfi La Iqwigasmusgba Bkqvnwvaq Dyg Hcacdejl Uqugqriizoczn Ll Prq	Madrid	Spain
Jae Bdyilz Rckoqduz Scyl	Cracow	Poland
Axpf Cmokmcmd svbuts	Prague	Czechia
Nnxhuojr Zsuj sgyfxo	Zlin	Czechia
Hnhmqalm Vepw dfwxpnqv	Barcelona	Spain
Iqgylqyq Zhxwxet Do Btkifrzxbsaqoqnwn	Oświęcim	Poland
Kxctbmbwf shscwc	Dubnica nad Váhom	Slovakia
Igkrm Ojatczam Aqxaezeifi Scb Lsgi	Milan	Italy
Fzfxxlmoj Nlwhyjrgta	Zaragoza	Spain

Trial status

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

Trial locations

Investigated drugs:

Clostridium Botulinum Neurotoxin Type A (150Kd), Free Of Complexing Proteins

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 migraine prevention, it helps reduce the frequency and severity of headaches by relaxing muscles and potentially blocking pain signals. The treatment involves a series of small injections in specific points around the head and neck area. This medication is already approved for various medical conditions, including chronic migraine, and is now being studied for episodic migraine prevention.

Episodic Migraine – A neurological condition characterized by recurring headache attacks that occur between 4 and 14 days per month. These headaches typically cause moderate to severe throbbing pain, often on one side of the head, and can last from 4 to 72 hours if untreated. During migraine episodes, patients commonly experience sensitivity to light, sound, and movement, and may also have nausea or vomiting. Between migraine attacks, patients typically return to their normal state without headache symptoms. The condition tends to run in families and can be influenced by various environmental and hormonal triggers.

Trial ID:

2024-515715-22-00

Protocol code:

M602011085

Trial Phase:

Therapeutic confirmatory (Phase III)

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study of IncobotulinumtoxinA injections compared to placebo for prevention of episodic migraine attacks

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?