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

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.

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Neurology and Pain Specialty Center /ID# 278508, Aliso Viejo, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Percentage of Participants with Absence of moderate to severe headache over 24 hours post-dose during prodrome.

Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Krystal Spenta

CONTACT

[email protected]

844-663-3742

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

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

Acronym: PHASES

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Dec 30, 2025
Registry last updated: Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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