Using ubrogepant during the migraine prodrome to reduce attack severity

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

This project will try taking oral ubrogepant during the migraine prodrome to see if it reduces attack severity in adults who already take ubrogepant.

Quick facts

• Study type: Observational
• Enrollment: 189 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: AbbVie (industry)
• Locations: 3 sites (Aliso Viejo, California and 2 other locations)
• Trial ID: NCT07310290 on ClinicalTrials.gov

What this trial studies

This observational study will enroll adults with a clinical diagnosis of migraine who have 4–10 migraine days per month and who have been using prescription ubrogepant for at least 3 months. About 189 participants across roughly 15 US sites will continue their prescribed ubrogepant as part of routine care and record timing and severity of migraine attacks over a follow-up period of up to 13 weeks. The study compares patient-reported attack severity when ubrogepant is taken during the prodrome phase versus usual acute treatment timing using real-world data. No study drug is provided and participants attend regular clinic visits according to their usual care.

Who should consider this trial

Good fit: Adults with an ICHD-3 diagnosis of migraine who experience 4–10 migraine days per month and have been prescribed and using ubrogepant for at least 3 months are ideal candidates.

Not a fit: Patients not prescribed ubrogepant, using strong CYP3A4 inhibitors, enrolled in other concurrent studies, or who do not meet the 4–10 migraine days per month criterion are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, taking ubrogepant during the prodrome could lessen headache severity and associated symptoms, improving symptom control and reducing the impact of attacks.

How similar studies have performed: Ubrogepant is approved for acute migraine relief, but using it specifically during the prodrome phase has limited evidence from large real-world studies and remains relatively untested.

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

Where this trial is running

Aliso Viejo, California and 2 other locations

• Neurology and Pain Specialty Center /ID# 278508 — Aliso Viejo, California, United States (RECRUITING)
• Chicago Headache Center & Research Inst /ID# 272345 — Naperville, Illinois, United States (RECRUITING)
• Tri City Research Center, LLC /ID# 278800 — Grand Island, Nebraska, United States (RECRUITING)

Study contacts

• Study coordinator: Krystal Spenta

Conditions: Migraine, Ubrogepant, UBRELVY