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

AbbVie

Status: Not yet enrolling

Conditions: Migraine

Study type: Observational

Funder types: Industry

Identifiers

NCT07310290

P25-590

Details and patient eligibility

About

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.

Enrollment: 189 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

189 participants in 1 patient group

Ubrogepant

Description:

Participants will receive Ubrogepant as prescribed by their physician according to local label.