Phase 3 Migraine Trial, Recruiting

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

Who might be able to join this trial:

• People aged 18 to 75 years old at the time of signing the consent form, of any gender.
• People who have had migraines (with or without aura) for more than one year, where untreated migraines typically last between 4 and 72 hours.
• People who have had at least 2 but no more than 10 moderate or severe migraine attacks per month in each of the 2 months before the screening visit.
• Men are eligible regardless of reproductive considerations.
• Women who are post-menopausal (defined as at least 12 months without a period, or at least 6 months without a period with a confirming hormone blood test result, or at least 6 weeks after surgical removal of both ovaries).
• Women who have had a hysterectomy or removal of both fallopian tubes.
• Women of reproductive potential who agree to abstain from heterosexual activity, or who agree to use an acceptable form of contraception from the first dose of study medication until the end of the study (acceptable methods include hormonal contraception, IUD, IUS, bilateral tubal occlusion, vasectomised partner, condoms, or barrier methods with spermicide — confirm specifics with the trial site).
• People who are willing and able to give written consent to participate.
• People who are able to read, understand, and complete study questionnaires and a digital diary on a personal smartphone.
• People who are willing and able to attend all scheduled visits and follow all study procedures.
• People who are willing to download a study-specific app on their own compatible smartphone.

Who may not be able to join:

• Women who are pregnant, breastfeeding, or planning to become pregnant during the trial.
• People who have difficulty telling the difference between their migraines and tension-type headaches.
• People whose migraines are usually mild, or typically go away on their own within less than 2 hours.
• People who have had more than 15 headache days per month, or who have taken medication for headaches on more than 10 days per month, in any of the 3 months before screening.
• People who have a specific type of migraine known as brainstem (basilar-type), hemiplegic, or retinal migraine.
• People whose migraines first began after age 50.
• People who are taking migraine prevention medication where the dose has changed in the 3 months before screening, or where a change is expected during the study (any stopped preventive medication must have been stopped at least 30 days before screening).
• People who have, in the investigator's opinion, other significant pain conditions, uncontrolled major depression, a history of psychosis, dementia, or other significant neurological conditions besides migraine (note: people with well-controlled depression on permitted medication may still be considered eligible — confirm with trial site).
• People who, in the investigator's opinion, are at immediate risk of harming themselves or others, or who have reported suicidal thoughts with intent in the past 2 months or suicidal behaviour in the past 6 months.
• People who have had a significant or unstable health condition affecting the hormone system, blood, immune system, kidneys, lungs, nervous system, digestive system, liver, or urinary system within the past 3 years that, in the investigator's opinion, could affect their safety or the study results.
• People with a history of cancer within the past 5 years (some types of treated skin cancer may be allowed — confirm with trial site).
• People with uncontrolled, unstable, or recently diagnosed heart or circulation problems, including heart attack, stroke, or a mini-stroke (TIA) within the 6 months before screening.
• People with a history of HIV.
• People who have had stomach or small intestine surgery (such as gastric bypass or banding) or have a condition that causes poor absorption of food or medication (removal of the gallbladder or appendix is generally allowed — confirm with trial site).
• People who test positive at screening for hepatitis B or hepatitis C.
• People whose kidney function blood test result at screening falls below the study's required level (confirm specific threshold with trial site).
• People whose liver enzyme or bilirubin blood test results at screening are above the study's accepted limits (confirm specific thresholds with trial site).
• People whose heart electrical activity measurement (QTcF interval) at screening is above the accepted level for their gender (confirm specifics with trial site).
• People whose blood pressure at screening is above 160 mmHg (systolic) and/or 95 mmHg (diastolic) after rest, even after a repeat measurement.
• People with a known or suspected history of alcohol or recreational drug misuse at screening.
• People who have used cannabis, THC, or CBD products within 3 months before screening, or cocaine or illicit narcotics within 6 months before screening.
• People who return a positive drug screening test at the time of screening (some exceptions may apply for prescribed medications such as benzodiazepines or stimulants — confirm with trial site).
• People who are taking, or expected to take, medications that are not permitted under the study protocol.
• People who have used prescription opioid (opiate) medications within 14 days of screening, or who anticipate needing opioids during the study.
• People who have regularly used ergotamine-based medications for 10 or more days per month for 3 or more months before screening.
• People who have used non-narcotic pain relievers for 15 or more days per month for 3 or more months before screening.
• People with a known or suspected allergy or sensitivity to the study medication or related products.
• People with a history of multiple significant allergies or a severe allergic reaction (anaphylaxis) to any prescription or non-prescription drugs or foods.
• People who have surgery planned at any point during the trial period.
• People whose blood haemoglobin (red blood cell) level at screening is below the study's required level for their gender, or who have a known blood disorder affecting haemoglobin (confirm specific values with trial site).
• People who have previously signed a consent form for this trial.
• People who have participated in a clinical trial of a biological medicine (such as an antibody therapy) within the past 90 days, or a small-molecule medicine within the past 30 days or 5 half-lives (whichever is longer), or who have ever signed consent for a specific related study (Study K-304 P004).
• People who are employees of the company sponsoring the trial, or who are an immediate family member of a sponsor or study site employee.
• People who, in the investigator's opinion, have any other condition or circumstance that could affect their safety or the reliability of the study results.

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