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:

• People aged 18 to 75 years (inclusive), of any gender
• People with a body mass index (a measure of body weight relative to height) below 35
• People who have had migraines (with or without aura) for at least 1 year, diagnosed according to recognised international headache guidelines
• People whose migraines first started before the age of 50
• People whose migraine attacks, when untreated or when treatment has not worked, typically last between 4 and 72 hours
• People who have had 2 to 8 moderate-to-severe migraine attacks per month on average over the last 3 months
• People who have had fewer than 15 days with any type of headache per month on average over the last 3 months
• People already taking a daily migraine prevention medication may be eligible, provided the dose has been stable for at least 3 months before joining and is not expected to change during the trial
• People diagnosed with chronic migraine who, because of stable preventive treatment, currently have fewer than 15 headache days and 2 to 8 moderate-to-severe attacks per month, and who meet all other criteria, may also be eligible
• People who are able to understand and fill in study questionnaires using an electronic device

Who may not be able to join:

• People who have a history of certain specific migraine types, including migraine with brainstem aura, retinal migraine, or hemiplegic migraine
• People with poorly controlled, unstable, or recently diagnosed heart or blood vessel disease, including: a heart or circulation condition diagnosed within the past 6 months; a previous stroke, mini-stroke, heart attack, or heart surgery; an abnormal heart tracing (ECG) at the screening visit; poorly controlled diabetes or high blood pressure; or severe circulation problems in the limbs
• People with structural problems inside the nose, sores or abnormalities of the nasal lining, or any condition that could affect how a nasal (inhaled through the nose) medication is absorbed
• People with taste disturbances or taste disorders
• People with ongoing acute or long-term pain conditions, or any other pain that the trial doctor believes could make it difficult to assess the study results
• People who have regularly used ergotamine or triptan medications on 10 or more days per month for 3 or more months, or who have regularly used non-prescription pain relief (such as paracetamol, anti-inflammatory drugs, or gabapentin) on 15 or more days per month for 3 or more months
• People with certain abnormal blood test results related to hepatitis B, hepatitis C, syphilis, or HIV at the screening visit
• People with a history of alcohol or drug misuse within the past year, or a positive drug screening test at the screening visit
• Women who are pregnant or breastfeeding, or who test positive for pregnancy at the screening visit
• People with a known allergy or sensitivity to the trial medication or any of its ingredients

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