Migraine Study Self Scheduler

Basic Criteria 

1. Age 18 to 75 years old 
2. Been diagnosed with migraines — with or without aura (visual or sensory warning signs before the headache) — for more than one year, either by a doctor or confirmed by having taken a migraine medication for over a year.  
3. In the past two months, how many migraines do you typically have each month? 

Answers Must Be NO 

1. Have you had gastric bypass, gastric banding, or other stomach/intestinal surgery, or have you been diagnosed with a condition that affects how your body absorbs nutrients?
2. Are you currently pregnant, breastfeeding, or planning to become pregnant during the study? 
3. In the last 3 months, have you had more than 15 headaches per month?  
4. In the last 3 months have you taken medication for headaches on more than 10 days per month? 
5. Do you have difficulty telling your migraines apart from regular tension headaches? 
6. Do your migraines tend to be mild and usually go away on their own in under two hours without treatment? 
7. Have you ever been diagnosed with a brainstem (migraine that starts in the “base” of your brain (the brainstem) migraine, causing temporary weakness on one side of the body, or a migraine affecting vision in one eye? 
8. Were you older than 50 when you had your very first migraine? 
9. In the last 3 months, has your doctor changed the daily dose of any migraine medication you take, or do you expect a change during the study? 
10. Do you have a history of, or are you currently dealing with, alcohol or recreational drug misuse? 
11. In the last 3 months, have you used marijuana or any products containing THC or CBD?  
12. In the last 6 months, have you used hard drugs like cocaine or illicit opioids/narcotics? 
13. In the last 14 days, have you used any prescription opioid pain medication, or do you expect to need one during the study? 
14. In the last 3 months have you regularly used ergotamine-type migraine medications (like Migranal or Cafergot) for more than 10 days?  
15. In the last 3 months, have you taken non-prescription pain relievers (like ibuprofen or acetaminophen) if yes, would you say you have taken it for more than 15 days per month? 
16. Other than migraine, have you ever been diagnosed with any significant pain condition, dementia, psychosis?  
17. Do you have a diagnosis of depression that is currently not well controlled? 
18. Have you had thoughts of harming yourself with intent or a plan in the past 2 months, or any self-harm behavior in the past 6 months? 
19. In the last 3 years, have you been diagnosed with — or currently show signs of — a significant hormone, blood, immune system (including Sjögren’s syndrome), kidney, lung, nervous system, digestive, gallbladder/liver duct, or urinary condition that a doctor felt was serious? 
20. Have you had cancer in the last 5 years?
21. Have you had a heart attack, unstable chest pain (acute coronary syndrome), a heart procedure/surgery, stroke, or mini stroke (TIA) in the last 6 months? 
22. Do you have unstable (not on medication) heart conditions (example, hyper/hypotension, chest pains, if unsure of conditions, document and reach out to clinical team)? 
23. Have you ever been diagnosed with HIV? 
24. Are you positive for hepatitis B? 
25. Have you ever had a positive result for hepatitis C? 
26. Do you have a history of any severe allergies or intolerances (food, drug, or latex), or have you ever had a serious allergic reaction to food or medication? 
27. Do you have any surgery scheduled during the time you will be in this study? 
28. Have you ever taken part in this same study before? 
29. Have you participated in a clinical trial for an investigational biologic drug in the last 90 days, or an investigational non-biologic drug in the last 30 days? 
30. Are you, or is an immediate family member (spouse, parent, child, or sibling), an employee of this study site or the study sponsor? 

Answers Must Be YES 

1. (For female participants who could become pregnant) Are you willing to use an acceptable form of birth control (or abstain from sex) for the duration of the study? 
2. Acceptable methods of birth control are:  

• combined (estrogen and progestogen containing) hormonal contraception: oral, intravaginal, transdermal 
• progestogen-only hormonal contraception: oral, injectable, implantable 
• IUD, IUS, bilateral tubal occlusion 
• vasectomized partner, heterosexual abstinence  
• male or female condom with or without spermicide 
• cap, diaphragm or sponge with spermicide  
• A combination of male condom with either cap, diaphragm or sponge with spermicide (double barrier methods) 
• A female who is of non-childbearing potential defined by at least 1 of the following criteria:  
• Postmenopausal for a minimum of 12 months of spontaneous amenorrhea OR 
• Post hysterectomy or bilateral salpingectomy, based on the subject’s 

1. Are you willing to provide written informed consent to participate? 
2. Do you have your own smartphone you’d be willing to use to download a study app for tracking symptoms? 
3. Are you willing and able to attend all required study visits and follow the study’s procedures?