A Study to Evaluate IPN10200 Safety and Efficacy in the Prevention of Episodic or Chronic Migraine in Adults

Inclusion Criteria:

1. Capable of giving signed informed consent, which includes compliance with therequirements and restrictions listed in the ICF. Participant has provided writteninformed consent and signed privacy/data protection documentation;

2. Male or female ≥18 to 80 years of age at the time of signing the informed consent;

3. Diagnosis of either EM or CM, per ICHD-3 criteria, for at least 12 months prior tothe screening visit;

4. Diagnosis of migraine at ≤50 years of age;

5. Participants in the EM group: History of EM diagnosis and headache frequency (i.e.migraine and non-migraine headache): ≤14 headache days in the 4 weeks prior torandomisation on study Day 1 based on information recorded in the eDiary; migrainefrequency: ≥6 migraine days in the 4 weeks prior to randomisation on study Day 1based on information recorded in the eDiary;

6. Participants in the CM group: History of CM diagnosis and headache frequency (i.e.migraine and non-migraine headache): ≥15 headache days in the 4 weeks prior torandomisation on study Day 1 based on information recorded in the eDiary; migrainefrequency: ≥8 migraine days in the 4 weeks prior to randomisation on study Day 1based on information recorded in the eDiary;

7. Participant with a history of use of at least one preventive treatment for migraine.

Exclusion Criteria:

1. History or current diagnosis of migraine with brainstem aura, retinal migraine,complications of migraine, tension-type headache, trigeminal autonomic cephalalgias,hypnic headache, hemicrania continua or new daily persistent headache;

2. Headache attributed to another disorder (e.g. secondary headaches), exceptmedication overuse headache (MOH);

3. Current uncontrolled psychiatric or psychological condition, or one that couldconfound assessment of headaches/migraines or interfere with study participation;

4. Risk of self-harm or harm to others as evidenced by past suicidal behaviour orendorsing items 3, 4, or 5 on the C-SSRS at screening or Day 1.

5. Participants presenting with a swallowing disorder of any origin which might beexacerbated by botulinum toxin treatment, such as:

• Grade 3 or 4 on the Dysphagia Severity Scale (severe dysphagia) with swallowingdifficulties and requiring a change in diet.

6. Clinically relevant skin condition or infection that could interfere with injectionof study intervention;

7. Participant has any medical condition or situation that would make them unsuitablefor participation in the study;

8. Participant receiving more than one allowable concomitant migraine preventivetreatment;

9. Known history of an inadequate response to >4 medications prescribed for theprevention of migraine (2 of which have different mechanisms of action to botulinumtoxin);

10. Use of any of the following medications in the specified timeframe prior to thescreening visit:

• Botulinum toxin for migraine within 24 weeks (or for any othermedical/aesthetic reason within 16 weeks);

• Prior use of mAbs blocking CGRP pathway within 12 weeks for preventativetreatment of migraine

• Prior use of oral CGRP receptor antagonist (gepants) for preventative treatmentof migraine within 2 weeks;

• Anaesthetic or steroid injection in any region targeted for treatment withstudy medication within 4 weeks;

• Use of cannabidiol or other types of cannabinoids within 30 days;

• Use of medical device to treat migraine within 4 weeks (e.g. non-invasiveneuromodulation therapies such as nerve stimulation (gammaCore), transcranialmagnetic stimulation (cephaly), external trigeminal nerve stimulation,transcutaneous electrical nerve stimulation and peripheral neuroelectricalstimulation);

• Use of other intervention to treat migraine that is assessed to interfere withstudy evaluations within 4 weeks (e.g. acupuncture in the head and neck region,cranial traction, nociceptive trigeminal inhibition, occipital nerve blocktreatments and dental splints for headache);

• Use of opioids or barbiturates for more than 2 days/month within the last 4weeks.

11. Concurrent participation in another interventional clinical study (or withinspecified timeframe according to national or local legislation or requirements);

12. Diagnosis of other significant pain disorders that could confound the assessment ofheadaches/migraines or interfere with study participation, including but not limitedto chronic pain disorders such as fibromyalgia, chronic low back pain and complexregional pain syndrome;

13. Pregnant women, nursing women, premenopausal women, or WOCBP (i.e. not surgicallysterile or 1 year postmenopausal) not willing to practice an acceptablecontraceptive method, at the beginning of the study and for a minimum of 12 weeksfollowing the administration of study treatment;

14. Male subjects who are not vasectomised and who have female partners of childbearingpotential and are not willing to use condoms with spermicide for a minimum of 12weeks following the initial double-blind administration of the treatment;

15. History of alcohol or drug abuse within 5 years of the screening visit (excludingmedication overuse for headache);

16. Body mass index (BMI) ≥35 kg/m² at the screening visit;

17. Known clinically significant hypersensitivity to any of the study drugs, excipientsor materials used to administer the study drug;

18. Patients who, in the clinician's judgment, are actively suicidal, and therefore,deemed to be at significant risk for suicide.

19. A diagnosis of a neuromuscular disorder or respiratory disorder, such as myastheniagravis, Lambert-Eaton syndrome or amyotrophic lateral sclerosis that in the opinionof the investigator would compromise the safety of the study participant.