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NCT05503082 · ClinicalTrials.gov record · last posted 2024-08-20

Ubrogepant treatmeNt in mIgraine Patients Utilizing mOnoclonal aNtibodies

Study acronym: UNION
StatusActive, Not Recruiting
PhasePhase 4
Started2022-09-06
View on ClinicalTrials.gov ↗
Record status
This record was last updated August 20, 2024 (before its estimated September 2024 completion). Its status may not reflect the trial's current state.
from the ClinicalTrials.gov record
This is a prospective open-label randomized study assessing similar endpoints included in the pivotal trial for ubrogepant, which are pain freedom and freedom from the most bothersome symptom at two hours. Patients between 18-75 years old with a one-year history of migraine who experience ≥3 migraine days/month will be screened. This study will include migraine patients treated with or without injectable CGRPmAbs. As was the case in the clinical trials, this will be a single-attack study. Patients will be randomized to treat a single migraine attack with ubrogepant 50mg or 100mg. Patients will record dosing time, most bothersome symptom (nausea, photophobia, or phonophobia - chosen by patient), pain freedom, pain relief, the use of a 2nd dose if required, and adverse reactions. Patients will follow up within 30 days post treatment. Patients will be assessed for adverse events, and the safety data will be compared with the original clinical trial.

Amendment record 4 amendments on the ClinicalTrials.gov record

This ClinicalTrials.gov record has been amended 4 times since 2022-08-14; most recent amendment 2024-08-19. DataLookout shows field-level changes from the day a trial enters its daily monitoring; earlier amendments are counted here from the ClinicalTrials.gov version history. See every version on ClinicalTrials.gov ↗

2024-08-19
Status change RecruitingActive, Not Recruitingv4
2023-02-03
Status change Not Yet RecruitingRecruitingv1
Trial Details
NCT Number NCT05503082
Lead Sponsor Chicago Headache Center & Research Institute
Collaborators: AbbVie
Conditions Headache, Migraine
Enrollment 164 participants
Start Date 2022-09-06
Primary Completion 2024-09 (estimated)
Study Completion 2024-11 (estimated)
Updated on ClinicalTrials.gov 2024-08-20