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:

• Adults between 18 and 75 years old who have been diagnosed with Chronic Daily Headache that has not responded well to medical treatments.
• People whose headaches occur on 15 or more days per month, and have done so for at least 3 months at a time, as defined by international headache guidelines.
• People whose condition has not improved after trying at least 3 different headache prevention treatments.
• People whose headaches are severely disabling, based on a standard headache disability scoring tool (MIDAS score of 21 or higher, Grade IV).
• People who score 6 (very severe) or 7 (extremely severe) on a standard headache severity rating scale (GAMS).
• People whose headaches are at least moderate to severe in pain intensity (above 5 on a standard pain scale) in at least half of their headaches.
• People who have had a Chronic Daily Headache diagnosis for at least 12 months before the screening appointment, confirmed through medical records and/or their own account.
• People whose current headache prevention treatment has not adequately reduced headache frequency, duration, or severity at a standard dose for at least 6 weeks, as reported to their treating doctor.
• People who have been on a stable headache medication and prevention treatment for the 3 months before screening.
• People who record 15 or more headache days per month in a personal diary during the study's baseline period.
• People who complete their daily headache diary on at least 75% of days during the 28-day baseline period.
• People who still meet all eligibility criteria when reassessed at the end of the baseline period.

Who may not be able to join:

• People who have started a new migraine prevention treatment within the past 3 months.
• People with a known allergy or sensitivity to lidocaine (a local anaesthetic).
• People currently using a Lidoderm (lidocaine) patch, unless it has been removed for at least 3 days before the procedure.
• People with a severe allergy or anaphylactic reaction to iodinated contrast dye (a substance used in certain medical scans).
• People who have any abnormal findings inside the brain on a CT or MRI scan taken within the past 12 months.
• People with a chronic subdural hematoma (a type of blood collection on the brain).
• People who have had a stroke or heart attack within the past 3 months.
• People with a history of reduced kidney function (based on a blood test result) within the past 3 months (confirm with trial site).
• People with a history of abnormal heart rhythm recordings (ECG) within the past 3 months, specifically those with prolonged QT syndrome.
• People taking medications that may affect heart rhythm, such as certain anti-nausea or anti-vomiting medicines (confirm with trial site).
• People taking any medication that controls heart rhythm, other than beta blockers.
• People with symptomatic peripheral arterial disease (reduced blood flow to the limbs causing symptoms).
• People with a known inherited or acquired bleeding disorder (not including blood-thinning or antiplatelet medications).
• People with evidence of active substance use disorders, addictive disorders, or recreational use of illicit drugs within the 12 months before screening, based on medical records, self-report, or a urine drug test.
• People with active ongoing chronic pain conditions, such as fibromyalgia or chronic pelvic pain.
• People with a history of a major psychiatric disorder, or who currently show moderately severe or severe depression based on a standard questionnaire (PHQ-9 score of 15 or higher at screening).
• People with a history of anxiety disorder or major depressive disorder may still be considered if their depression score is below 15 on the PHQ-9 and they are taking no more than one medication for each condition, for at least 2 months before screening (confirm with trial site).
• People who are pregnant, planning to become pregnant, or planning to make a partner pregnant during the study, unless reliable contraception is in place.
• People who, in the opinion of the trial investigator, have any other condition that would make participation unsuitable.

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