Phase 3 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 who have had a diagnosis of migraine (with or without aura) for at least 6 months, based on recognised international headache guidelines.
• People whose migraines typically last between 3 and 72 hours when untreated or not fully treated, with at least 48 hours of being pain-free between episodes.
• People who have had 1 to 14 migraine attacks per month, each with moderate to severe headache pain, in the 2 months before the first study visit.
• People who are currently using or have previously used at least one oral medication (either over-the-counter or prescription) to treat migraine attacks.
• People (in the main part of the study) who took a single-blind placebo during the screening period to treat a qualifying migraine and completed a pain check at 2 hours after taking it.
• People who weigh at least 20 kg (44 pounds) and less than 135 kg (298 pounds).
• People who are able to swallow tablets, or who the study doctor believes can learn to do so.
• People who are able to understand and fill in study questionnaires and an electronic diary — those who need reading assistance may be helped by a parent or guardian.

Who may not be able to join:

• People who have a significant medical condition affecting the blood, hormones, lungs, kidneys, liver, digestive system, heart, or nervous system.
• People who, in the study doctor's opinion, have other pain conditions, significant psychiatric conditions, or other major neurological disorders besides migraine.
• People who have had a cancer diagnosis in the 5 years before the first study visit.
• People who have a history of gastrointestinal conditions (such as chronic diarrhoea or inflammatory bowel disease) that could affect how the body absorbs or processes the study drug.
• People who are assessed as having a significant risk of self-harm or harm to others — including those who have reported suicidal thoughts with intent, or suicidal behaviour, in the past 6 months.
• People who, in the study doctor's opinion, currently have an alcohol or drug abuse or dependence problem at the time of the first study visit.
• People (in the main part of the study) who had no headache at the 2-hour check after taking the single-blind placebo during screening, as this suggests they may be responding to placebo rather than the study treatment.
• People who have a current diagnosis of chronic migraine as defined by international headache guidelines.
• People who are overusing medication for migraine — for example, using opioids or barbiturates more than 2 days per month, triptans or ergots 10 or more days per month, or simple pain relievers 15 or more days per month, in the 3 months before the first study visit (confirm specific thresholds with trial site).
• People who have difficulty telling their migraine headaches apart from tension-type or other headaches.
• People who have a history of migraine with double vision, loss of consciousness, weakness on one side of the body (hemiplegic migraine), or retinal migraine, as defined by international headache guidelines.
• People who currently have a diagnosis of new daily persistent headache, cluster headache, or painful nerve conditions affecting the head, as defined by international headache guidelines.
• People who have needed hospital admission (not counting emergency department visits) for migraines 3 or more times in the 6 months before the first study visit.
• People who require a medication or dietary item (such as grapefruit juice) that is on the trial's prohibited list and cannot be stopped or switched to an alternative at the first study visit.
• People who have received an injectable antibody treatment targeting the CGRP pathway (a type of migraine preventive treatment) within the 6 months before the first study visit.
• People who have had an allergic or significant adverse reaction to a CGRP receptor-blocking drug, or to any ingredient in the study drug (ubrogepant) or placebo.
• People who are currently in another clinical trial or have participated in one involving an investigational drug or device within the 30 days before the first study visit.

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