Phase 2 Migraine Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You are willing and able to sign a consent form agreeing to take part in the study.
• You are male or female and are 25 years of age or older.
• You have been diagnosed with migraines for at least 12 months, based on standard medical guidelines for headache disorders.
• You have been experiencing chronic migraines for at least the 3 months before your screening appointment, based on standard medical guidelines.
• If you are currently taking migraine prevention medications (including Botox injections), your dose has been stable for at least 3 months and you are not planning to change it during the study.
• If you are a female who could become pregnant, you are using a reliable form of birth control.
• You have tried at least 2 migraine prevention treatments in the past that either did not work well enough or caused side effects you could not tolerate.
• You are able to follow the study steps, keep a headache diary, and fill out questionnaires.
• You completed your headache diary at least 90% of the time during the one-month preparation period before the study begins.

Who may not be able to join:

• You have another type of ongoing primary headache condition, such as cluster headaches (confirm with trial site).
• You have headaches caused by another medical condition, such as problems with fluid or pressure in the brain (confirm with trial site).
• You are currently pregnant, trying to become pregnant, or breastfeeding.
• You have a significant history of or are currently experiencing a serious mental health condition, such as severe depression, severe anxiety, psychosis, or schizophrenia.
• You have a current or past history of substance use disorder.
• You have regularly used cannabis (for any reason) in the past 12 months.
• You have a significant history of heart or blood vessel disease, such as a heart attack, stroke, or poor circulation in the limbs.
• You have a history of high blood pressure above 160/100 that has not been treated with medication.
• You have any history of seizures or a seizure disorder.
• You have liver disease or abnormal liver test results at the start of the study (confirm with trial site).
• You have severe kidney disease or your kidneys are not working as well as expected (confirm with trial site).
• You have a condition that causes excessive sleepiness or daytime drowsiness, such as narcolepsy, or you regularly use sleep-inducing medications.
• You have any other medical condition that the study doctors believe could put your health at risk if you join the trial.
• You have used certain headache treatments — such as nerve blocks, sphenopalatine ganglion blocks, or brain stimulation devices — during the month before the study starts or plan to use them during the 12-week study period.
• You have used short-term treatments like steroid courses or dihydroergotamine protocols during the month before the study or plan to use them during the 12-week study period.
• You have used triptan, dihydroergotamine, opioid, or barbiturate medications 10 or more days per month in the 3 months before joining the study.
• You have used common pain relievers (such as acetaminophen, ibuprofen, or aspirin) or anti-inflammatory medications 15 or more days per month in the 3 months before joining the study.

Important: Always verify eligibility with the trial site directly before applying.