RECRUITINGOBSERVATIONAL

Study to Assess the Real-World Effectiveness of Ubrogepant in Adult Participants When Treating During the Prodrome Phase of Migraine Attacks

PHASES: Prodrome in tHe reAl World: aSsESsing Ubrogepant Acute Use

About This Trial

Migraine is a neurological disease characterized by moderate or severe headaches, associated with nausea, vomiting, and/or sensitivity to light and sound. This study will assess changes in migraine attack severity for adult participants treating with oral ubrogepant across migraine attacks. Ubrogepant is a drug that is approved for the acute treatment of migraine in adults. Approximately 189 participants will be enrolled in approximately 15 sites across the US. Participants will receive ubrogepant as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 13 weeks. There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.

Who May Be Eligible (Plain English)

Who May Qualify: - History of 4 to 10 migraine days per month with moderate to severe headache pain in each month of the 3 months prior to Visit 1 --a. Participants with a diagnosis of chronic migraine who report having 4 to 10 migraine days per month with moderate to severe headache pain in each month of the 3 months prior to Visit 1 due to concomitant preventive treatment are allowed in the study - Participant is currently prescribed ubrogepant and has been using ubrogepant for at least 3 months for the acute treatment of migraine in adults, according to the US Food and Drug Administration (FDA)-approved indication - Adult participants with current clinical diagnosis of migraine or chronic migraine according to International Classification of Headache Disorders (ICHD)-3 Who Should NOT Join This Trial: - Currently participating in a concurrent clinical or non-interventional study. - Concomitant use with a strong Cytochrome P450 3A4 (CYP3A4 ) inhibitor. - Current diagnosis of new persistent daily headache, trigeminal autonomic cephalgia, status migrainosus or painful cranial neuropathy as defined by ICHD-3 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * History of 4 to 10 migraine days per month with moderate to severe headache pain in each month of the 3 months prior to Visit 1 --a. Participants with a diagnosis of chronic migraine who report having 4 to 10 migraine days per month with moderate to severe headache pain in each month of the 3 months prior to Visit 1 due to concomitant preventive treatment are allowed in the study * Participant is currently prescribed ubrogepant and has been using ubrogepant for at least 3 months for the acute treatment of migraine in adults, according to the US Food and Drug Administration (FDA)-approved indication * Adult participants with current clinical diagnosis of migraine or chronic migraine according to International Classification of Headache Disorders (ICHD)-3 Exclusion Criteria: * Currently participating in a concurrent clinical or non-interventional study. * Concomitant use with a strong Cytochrome P450 3A4 (CYP3A4 ) inhibitor. * Current diagnosis of new persistent daily headache, trigeminal autonomic cephalgia, status migrainosus or painful cranial neuropathy as defined by ICHD-3

Locations (3)

Neurology and Pain Specialty Center /ID# 278508

Aliso Viejo, California, United States

Chicago Headache Center & Research Inst /ID# 272345

Naperville, Illinois, United States

Tri City Research Center, LLC /ID# 278800

Grand Island, Nebraska, United States