Do you suffer from pain caused by Episodic or Chronic Migraines?
This clinical research study is looking at the safety and effectiveness of an investigational medication option for preventing episodic or chronic migraine headaches.
A migraine is a headache with severe throbbing pain or a pulsating sensation, usually on one side of the head. It is often accompanied by feeling or being sick and a sensitivity to bright lights and sound. Migraines are caused by a series of events when the brain gets stimulated or activated, which causes the release of chemicals that cause pain. The experimental medication, IPN10200, is being evaluated to see if it stops the release of these chemical messengers.
Participants will need to complete a daily electronic migraine Diary (eDiary) and questionnaires throughout the study. The total study duration for a participant will be up to 44 weeks.
Would you like to take part?
As a volunteer in a research study, you will receive study-related medical care from the study doctor and regular follow up of your condition to monitor the safety and effectiveness of the care you will receive. Study volunteers are an important part of moving medical care forward.
You may qualify to participate in this study if you:
- Are capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF.
- Are male or female ≥18 to 80 years of age at the time of signing the informed consent
- Have a diagnosis of either episodic migraines (EM) or chronic migraines (CM), per ICHD-3 criteria, for at least 12 months prior to the screening visit
- Were diagnosed with migraine headaches at ≤50 years of age;
- 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 randomization on study Day 1 based on information recorded in the eDiary; migraine frequency: ≥6 migraine days in the 4 weeks prior to randomization on study Day 1 based on information recorded in the eDiary;
- 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 randomization on study Day 1 based on information recorded in the eDiary; migraine frequency: ≥8 migraine days in the 4 weeks prior to randomization on study Day 1 based on information recorded in the eDiary;
- Have a history of use of at least one preventive treatment for migraine
You may not qualify to participate in this study if you:
- Have a 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;
- Have headaches attributed to another disorder (e.g. secondary headaches), except medication overuse headache (MOH);
- Have any current uncontrolled psychiatric or psychological condition, or one that could confound assessment of headaches/migraines or interfere with study participation;
- Are at risk of self-harm or harm to others as evidenced by past suicidal behavior or endorsing items 3, 4, or 5 on the C-SSRS at screening or Day 1.
- Present 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.
- Have any clinically relevant skin condition or infection that could interfere with injection of study intervention;
- Have any medical condition or situation that would make them unsuitable for participation in the study;
- Are receiving more than one allowable concomitant migraine preventive treatment;
- Have a 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);
- Use 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.
- Are participating in another interventional clinical study (or within specified timeframe according to national or local legislation or requirements);
- Have any 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;
- Are a pregnant woman, nursing woman, premenopausal woman, 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;
- Are a male subject who is not vasectomised and who has 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;
- Have a history of alcohol or drug abuse within 5 years of the screening visit (excluding medication overuse for headache);
- Have a body mass index (BMI) ≥35 kg/m² at the screening visit;
- Have any known clinically significant hypersensitivity to any of the study drugs, excipients or materials used to administer the study drug;
- Are, in the clinician’s judgment, actively suicidal, and therefore, deemed to be at significant risk for suicide.
- Have 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
There are other eligibility requirements that the study doctor will review. Only the study doctor can determine whether you are eligible to participate in the study or not.
