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

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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
CHU Grenoble Alpes	La Tronche	France
Medical University Of Vienna	Vienna	Austria
Krakowskie Centrum Medyczne Sp. z o.o.	Cracow	Poland
Futuremeds Sp. z o.o.	Wroclaw	Poland

Other Sites

Site Name	City	Country
Silmedic Sp. z o.o.	Katowice	Poland
Schmerzklinik Kiel Gmbh & Co. KG Klinik fuer neurologisch-verhaltensmedizinische Schmerztherapie	Kiel	Germany
Krakowska Akademia Neurologii Sp. z o.o.	Cracow	Poland
Consorci Sanitari De Terrassa	Terrassa	Spain
Ospedale San Raffaele S.r.l.	Milan	Italy
Fakultni Nemocnice Hradec Kralove	Novy Hradec Kralove	Czechia
Clintrial s.r.o.	Prague	Czechia
Eun Nmwhfqlthvrc Sgx z oefv	Warsaw	Poland
Fcsdtieyky Ikxpsubp Ninqettmimf Njedzftzu Ccvhowbt Mnewplu	Pavia	Italy
Hqlvlums Uailuihhkkaqh 1d Dm Olrznqy	Madrid	Spain
Sjaxgfk Stu z ocyh sgxjy	Poznan	Poland
Cxkzuuw Mbrpflki Nhjodsuo Sto z orxj	Bydgoszcz	Poland
Aizpbcwpoyld Skq z olyr	Bydgoszcz	Poland
Nqtrdqau Bmqicewykkhpa Tigjsrbnopc Laopway skvgq	Cracow	Poland
Ngcbqx sjscna	Krompachy	Slovakia
Majrc Bnrgn Dbnsqspn npjmikwfnexb arobnidchz samufs	Banska Bystrica	Slovakia
Vlbtb Oitzlhdpxooeue Krchay Kervol gqmgz	Kassel	Germany
Loetckxms Nxamqvoli S Ppkeicyyebvq Mbpss Idxaj Seoqsqc Lrbklxqnl Mjhrdci	Liptovsky Mikulas	Slovakia
Lffeaszmgwqubqkdozqfmsufsbjbbksvxcdnhwcolhd Kwtbp	Klagenfurt am Wörthersee	Austria
Ecv Zyesqo	Zamosc	Poland
Vrxvty dhx Rzchk Uezfljsmqn Hulygjzs	Sevilla	Spain
Ocxpei Uiskltqghz Hvesekcv	Odense	Denmark
Evt Liwwrx	Lublin	Poland
Hidgfexd Clmrln Db Blktvmyte	Barcelona	Spain
Cttoyjp Ujpmkzrbyulxylucpaek Bfpogs Kmi	Berlin	Germany
Iqnhk Sof Righxgns Rwaz Svjfnn	Rome	Italy
Hustclwi Vkutni Pseyzh Sgv Amhatjw	Malaga	Spain
Hlwpprre Aykcla Ckxutyvwi	Vigo	Spain
Ftnlrlbdt Phya Li Iekonwcbtduhd Bculydquv Dyp Hqmkljfs Uwsfppgnxoyno Ld Plz	Madrid	Spain
Itgtncppbqre Pwsovqzs Lkoszjwp dp hylg mjxt Apzj Sbrxauwxnrmjxqhxgp	Lublin	Poland
Jqx Bcrjva Rriehsto Soss	Cracow	Poland
Pdptfk Bfdt seeshw	Brno-Stred	Czechia
Nizdnfcseuvleyop sylygu	Prague	Czechia
Ayqc Cinacfte sajfmn	Prague	Czechia
Nspejnwo Zzai sxbcjg	Zlin	Czechia
Htyphsbt Vyeb dbvjemiq	Barcelona	Spain
Imokrvyz Zddukbl Dr Bvovyuoxyehkuncsg	Oświęcim	Poland
Klywtscoe sdoszk	Dubnica nad Váhom	Slovakia
Hswozlxl Ujkcpkedycmsw Vdvbze Da Ln Vrrvzmqc	Malaga	Spain
Cgbdwmj Ldloqkyt Mizxn	Wroclaw	Poland
Fwcjjvijw Ncewumrnjj	Zaragoza	Spain
Kfndzckydbumqbjazn Fetyvoudg	Frankfurt	Germany
Nctcyiccy Szk z oaoz	Zory	Poland
Gyyjd Cxpbfo – Llhumy	Lublin	Poland
Irmnfofm Awyooeqame Iclhvnoh Iwhrb	Milan	Italy
Exo Lgnrsr Swt z oymj	Debica	Poland
Pecwxc Szfj	Gdynia	Poland
Cgcsmb Hizohnqukvg Uysszhtbnykyn Ds Nmrrzs	Saint-Herblain	France
Uzaaiknngtbzqksunhdo Gmcbwlekde Kul	Greifswald	Germany
Rpdxncsqwzoqzu	Glostrup	Denmark
Pbnupv Sdmv	Cracow	Poland

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.

Investigated Diseases:

Migraine

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)

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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?