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Ubrogepant treatmeNt in mIgraine Patients Utilizing mOnoclonal aNtibodies
NCT05503082 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- DRUG Ubrogepant 50 MG [Ubrelvy]
- DRUG Ubrogepant 100 MG [Ubrelvy]
Study Locations (2)
Illinois
- Chicago Headache Center & Research Institute — Chicago
- Chicago Headache Center & Research Institute — Naperville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 164 participants |
| Start Date | 2022-09-06 |
| Est. Completion | 2024-11 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05503082
The ClinicalTrials.gov registry entry for NCT05503082 describes a study currently listed as active not recruiting. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 164 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Chicago Headache Center & Research Institute, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Headache, Migraine appearing as the primary indexed condition, and to 2 interventions — of which Ubrogepant 50 MG [Ubrelvy] is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05503082 reports 2 study locations spanning 1 distinct geographic area — top geographies include Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05503082 about?
NCT05503082 is a clinical study titled "Ubrogepant treatmeNt in mIgraine Patients Utilizing mOnoclonal aNtibodies". 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 migrain...
What is the current status of trial NCT05503082?
This trial is currently active not recruiting. It is a Phase 4 study. The enrollment target is 164 participants. The study started on 2022-09-06. Estimated completion is 2024-11.
What conditions does trial NCT05503082 study?
This clinical trial studies the following conditions: Headache, Migraine. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05503082?
The interventions under investigation include: Ubrogepant 50 MG [Ubrelvy] (DRUG), Ubrogepant 100 MG [Ubrelvy] (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05503082?
This trial is sponsored by Chicago Headache Center & Research Institute, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05503082 being conducted?
This trial has 2 study locations across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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