Study to Assess the Real-World Effectiveness of Ubrogepant in Adult Participants When Treating During the Prodrome Phase of Migraine Attacks
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Migraine. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
PHASES: Prodrome in tHe reAl World: aSsESsing Ubrogepant Acute Use
Overview
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.
Primary outcome measures
- Percentage of Participants with Absence of moderate to severe headache over 24 hours post-dose during prodrome. [Time frame: Up to approximately 13 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 3 centers
- Neurology and Pain Specialty Center /ID# 278508 — Aliso Viejo
- Chicago Headache Center & Research Inst /ID# 272345 — Naperville
- Tri City Research Center, LLC /ID# 278800 — Grand Island
Identifiers
NCT: NCT07310290 · P25-590