Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:12 AM
Ignite Modification Date:
2025-12-25 @ 2:12 AM
NCT ID:
NCT06625060
Eligibility Criteria:
Inclusion Criteria:
1. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF. Participant has provided written informed 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 to the 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 to randomisation on study Day 1 based on information recorded in the eDiary; migraine frequency: ≥6 migraine days in the 4 weeks prior to randomisation on study Day 1 based 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 to randomisation on study Day 1 based on information recorded in the eDiary; migraine frequency: ≥8 migraine days in the 4 weeks prior to randomisation on study Day 1 based 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), except medication overuse headache (MOH);
3. Current uncontrolled psychiatric or psychological condition, or one that could confound assessment of headaches/migraines or interfere with study participation;
4. Risk of self-harm or harm to others as evidenced by past suicidal behaviour or endorsing 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 be exacerbated by botulinum toxin treatment, such as:
\- Grade 3 or 4 on the Dysphagia Severity Scale (severe dysphagia) with swallowing difficulties and requiring a change in diet.
6. Clinically relevant skin condition or infection that could interfere with injection of study intervention;
7. Participant has any medical condition or situation that would make them unsuitable for participation in the study;
8. Participant receiving more than one allowable concomitant migraine preventive treatment;
9. Known history of an inadequate response to \>4 medications prescribed for the prevention of migraine (2 of which have different mechanisms of action to botulinum toxin);
10. Use of any of the following medications in the specified timeframe prior to the screening visit:
* Botulinum toxin for migraine within 24 weeks (or for any other medical/aesthetic reason within 16 weeks);
* Prior use of mAbs blocking CGRP pathway within 12 weeks for preventative treatment of migraine
* Prior use of oral CGRP receptor antagonist (gepants) for preventative treatment of migraine within 2 weeks;
* Anaesthetic or steroid injection in any region targeted for treatment with study 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-invasive neuromodulation therapies such as nerve stimulation (gammaCore), transcranial magnetic stimulation (cephaly), external trigeminal nerve stimulation, transcutaneous electrical nerve stimulation and peripheral neuroelectrical stimulation);
* Use of other intervention to treat migraine that is assessed to interfere with study evaluations within 4 weeks (e.g. acupuncture in the head and neck region, cranial traction, nociceptive trigeminal inhibition, occipital nerve block treatments and dental splints for headache);
* Use of opioids or barbiturates for more than 2 days/month within the last 4 weeks.
11. Concurrent participation in another interventional clinical study (or within specified timeframe according to national or local legislation or requirements);
12. Diagnosis of other significant pain disorders that could confound the assessment of headaches/migraines or interfere with study participation, including but not limited to chronic pain disorders such as fibromyalgia, chronic low back pain and complex regional pain syndrome;
13. Pregnant women, nursing women, premenopausal women, or WOCBP (i.e. not surgically sterile or 1 year postmenopausal) not willing to practice an acceptable contraceptive method, at the beginning of the study and for a minimum of 12 weeks following the administration of study treatment;
14. Male subjects who are not vasectomised and who have female partners of childbearing potential and are not willing to use condoms with spermicide for a minimum of 12 weeks following the initial double-blind administration of the treatment;
15. History of alcohol or drug abuse within 5 years of the screening visit (excluding medication 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, excipients or 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 myasthenia gravis, Lambert-Eaton syndrome or amyotrophic lateral sclerosis that in the opinion of the investigator would compromise the safety of the study participant.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT06625060
Study Brief:
Protocol Section:
NCT06625060