Study of IPN10200 compared to placebo for prevention of episodic or chronic migraine in adults

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What is this study about?

This study focuses on people with episodic migraine or chronic migraine, which are conditions causing severe headaches. The research evaluates a new medication called IPN10200, which contains Clostridium botulinum neurotoxin, administered as an intramuscular injection. Some participants will receive the study medication while others will receive a placebo. The purpose is to determine if IPN10200 is effective in preventing migraines and to assess its safety.

The study medication or placebo will be given as a single treatment cycle. Throughout the study, participants will need to track their headaches and migraine days using an electronic diary. The study will monitor various aspects of participants’ health, including any changes in their condition and how their body responds to the treatment. The total duration of participation for each person will be 36 weeks.

During the study, researchers will evaluate how the treatment affects the number of days participants experience migraines each month. They will also monitor the use of other migraine medications and assess whether the study medication helps reduce both the frequency and severity of headaches. Regular health checks will be performed to ensure participant safety throughout the study period.

1 Initial screening and diagnosis confirmation

Your eligibility for the study will be verified based on your migraine history and current condition

The study accepts patients aged 18-80 who have been diagnosed with migraine before age 50

You must have experienced migraines for at least 12 months before screening

2 Electronic diary setup and baseline monitoring

You will receive an electronic diary to record your headache experiences

For episodic migraine: You must have 14 or fewer headache days and at least 6 migraine days in 4 weeks

For chronic migraine: You must have 15 or more headache days and at least 8 migraine days in 4 weeks

3 Treatment administration

You will receive either IPN10200 or placebo through intramuscular injection

This is a single treatment cycle study

Neither you nor your doctor will know which treatment you receive

4 Follow-up monitoring

Regular check-ups will occur over 36 weeks

Blood tests will be taken at weeks 4, 12, and 36

You will undergo facial examinations and heart monitoring (ECG)

Your electronic diary entries will continue throughout the study

Regular vital signs and laboratory tests will be conducted

5 Safety and effectiveness monitoring

Your migraine frequency and severity will be tracked

Any use of acute migraine medications must be recorded in your electronic diary

Any side effects or health changes will be monitored and documented

Tests for antibodies will be conducted at specific intervals

Who Can Join the Study?

  • Must be able to provide written informed consent and agree to follow study requirements
  • Age between 18 and 80 years old
  • Must have been diagnosed with either episodic migraine or chronic migraine for at least 12 months before screening
  • Must have received first migraine diagnosis before age 50
  • For patients with episodic migraine:
    • Must have 14 or fewer headache days in 4 weeks before starting the study
    • Must have at least 6 migraine days in 4 weeks before starting the study
  • For patients with chronic migraine:
    • Must have 15 or more headache days in 4 weeks before starting the study
    • Must have at least 8 migraine days in 4 weeks before starting the study
  • Must have previously used at least one preventive treatment for migraines

Who Cannot Join the Study?

  • Age less than 18 years or over 65 years old
  • Currently pregnant or breastfeeding women
  • History of any other type of headache disorder that could interfere with the diagnosis of migraine
  • Use of other preventive medications for migraine within 30 days before the study
  • Previous failure to respond to 2 or more classes of preventive migraine medications
  • History of serious allergic reactions to similar medications
  • Significant medical conditions that could affect the study results
  • Current participation in other clinical trials
  • History of substance abuse in the past 12 months
  • Mental health conditions that could interfere with study participation
  • Unable to follow study procedures or complete required documentation
  • History of chronic pain conditions other than migraine
  • Recent surgery within the past 3 months
  • Uncontrolled high blood pressure
  • History of severe cardiovascular disease (heart problems)

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Etg Neuroscience Sp. z o.o. Warsaw Poland
Centre Hospitalier Universitaire De Nimes Nimes France
Lukmed 2 Sp. z o.o. Siedlce Poland
Promed P.Lach R.Glowacki Sp. j. Cracow Poland
Pratia Brno s.r.o. Brno-Stred Czechia
Silmedic Sp. z o.o. Katowice Poland
Neurohk s.r.o. Chocen Czechia
Hospital Clinico Universitario De Valladolid Valladolid Spain
Specjalistyczne Gabinety Sp. z o.o. Cracow Poland
NeuropsychiatrieHK s.r.o. Prazske Predmesti Czechia
Schmerzklinik Kiel Gmbh & Co. KG Klinik fuer neurologisch-verhaltensmedizinische Schmerztherapie Kiel Germany
NeuroPoint Gesellschaft fur vorbeugende Gesundheitspflege GmbH Ulm Germany
Hospital Clinic De Barcelona Barcelona Spain
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Virgen del Rocío University Hospital Sevilla Spain
Synexus Polska Sp. z o.o. Poznan Poland
Ko-Med Centra Kliniczne Sp. z o.o. Zamosc Poland
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Universitaire Amiens Picardie Amiens France
Hopital Beaujon Clichy France
Centrum Leczenia MIGRE Wroclaw Poland
Kopfschmerzzentrum Frankfurt Frankfurt Germany
Uijlxnxjkkiabszlrvcon Ekokf Aqb Essen Germany
Hndjxrws Uthuaeploulzp Mkhgcza Dm Vmkovpbqsa Santander Spain
Slrygtva ulo Psogwhljytbdgwva Gpxftaxerx Goeppingen Germany
Fzbdftazec Gykc Offenbach Am Main Germany
Hjlhrzrs Vfsq dtjbhemo Barcelona Spain
Ijmkxleo Zfsgjgc Dz Bqnzzrggraeoxpxwm Oświęcim Poland
Plbpeg fff Nzomqnpttt uen Pxgaidwrtwz Dbh Cintsbpdo Ocvucihh Gera Germany

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

Trial status

Country Status Recruitment Start
Czechia Czechia
Not recruiting
15.08.2025
France France
Not recruiting
15.08.2025
Germany Germany
Not recruiting
15.08.2025
Poland Poland
Not recruiting
15.08.2025
Spain Spain
Not recruiting
15.08.2025

Trial locations

IPN10200 is an investigational medication being studied for preventing both episodic and chronic migraine in adults. It is being tested as a single treatment cycle to see if it can reduce the frequency of migraine headaches. The medication is being evaluated for its safety and how well the body tolerates it. The researchers are also studying whether the body might develop an immune response to the medication.

Episodic Migraine – A neurological condition characterized by recurring headache attacks that occur less than 15 days per month. These headaches typically cause moderate to severe throbbing pain, often on one side of the head, and can last between 4-72 hours. Episodes are frequently accompanied by nausea, sensitivity to light and sound, and may be preceded by visual or sensory disturbances called auras.

Chronic Migraine – A persistent neurological condition where headaches occur on 15 or more days per month, with at least 8 of those days featuring migraine characteristics, for more than three months. The headaches often cause pulsating pain of varying intensity and can be accompanied by nausea, vomiting, and heightened sensitivity to environmental stimuli. The condition can fluctuate in severity and frequency over time, with symptoms similar to episodic migraine but occurring more frequently.

Trial ID:
2024-511101-28-00
Protocol code:
CLIN-10200-454
NCT ID:
NCT06625060
Trial Phase:
Therapeutic exploratory (Phase II)

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