Migraine
Conditions
Keywords
Migraine, Ubrogepant, UBRELVY
Brief summary
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.
Interventions
None listed
Sponsors
AbbVie
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants with Absence of moderate to severe headache over 24 hours post-dose during prodrome. | Up to approximately 13 weeks | Prodrome is often the earliest phase of migraine attack and consists of various symptoms including sensitivity to light, fatigue, neck pain, sensitivity to sound, dizziness and difficulty thinking/concentrating. |
Countries
United States
Contacts
CONTACTKrystal Spenta
STUDY_DIRECTORABBVIE INC.
AbbVie
Outcome results
None listed